Roche Diagnostics VENTANA product portfolio
Transcription
Roche Diagnostics VENTANA product portfolio
HOME Roche Diagnostics International Ltd. CH-6343 Rotkreuz Switzerland www.roche.com www.ventana.com Roche Diagnostics VENTANA product portfolio © 2011 Ventana Medical Systems, Inc. and Roche Diagnostics International Ltd. VENTANA, the VENTANA logo, BENCHMARK, CONFIRM, DISCOVERY, INFORM, NexES, OPTISURE, PATHWAY, SYMPHONY, ultraView and VANTAGE are trademarks of Roche. All other trademarks are the properties of their respective owners. E2123 1011A 06562604001 third edition October, 2011 <PREV NEXT> Roche Diagnostics VENTANA Product Portfolio | Third Edition HOME Intelligent Systems | Intelligent Diagnostics | Intelligent Results | <PREV NEXT> We innovate staining platforms and workflow solutions that enable you to handle patient samples individually, even at your highest volumes. You can count on the people who created the first fully automated IHC, ISH and FISH slide staining capabilities to deliver the highest level of sophistication and consistency to your lab. Guided by science, we have developed the industry’s largest, most advanced portfolio of pre-diluted, ready-to-use reagents to support your lab. All of our antibodies are specially optimised for use on our cutting-edge instrumentation, to maximise the efficiency, precision and quality of routine and complex stains. Our Patient Focused Solution is an Intelligent System that gives you total confidence in your ability to deliver the right patient result. www.ventana.com | www.roche.com i HOME <PREV Now available | The lab of the future. Experience the ease and confidence that comes with optimised, ready-touse reagents, fully integrated automated staining platforms and worldclass workflow—all from a strategic partner who is positioned to deliver the most precise and personal cancer diagnostic solutions to any lab, anywhere in the world, right now. ii NEXT> HOME <PREV NEXT> Table of Contents Workflow Solutions 1 VENTANA VANTAGE Workflow Solution 3 Workflow Consulting 7 H&E 11 VENTANA SYMPHONY Fully Automated H&E System 13 Special Stains 17 VENTANA NexES Special Stains System 19 Special Stains 22 Ancillary Reagents 33 IHC & ISH 35 VENTANA BenchMark ULTRA System 37 VENTANA BenchMark XT System 41 VENTANA BenchMark GX System 45 Detection Chemistries 49 Primary Antibodies by disease state 55 Primary Antibodies by alphabetical listing 68 Immunofluorescence Antibodies 179 Research Primary Antibodies 183 Molecular Probes 185 Ancillary Reagents 193 VENTANA Digital Pathology 211 iScan Coreo Au Slide Scanner 213 Virtuoso Image Management Software 217 Customer Services 221 Technical Consultation Centre 223 Education and Training 227 Index 233 Disclaimer While we have made every effort to provide accurate and complete information in this catalogue, various data may change or be updated by the company at any time without notice. The company provides no warranty, express or implied, as to the accuracy, reliability or completeness of furnished data. Photos are an indication only and do not guarantee staining results. Some products may not be available in your country. Check with your local Roche representative for the availability of products in your region and the applicable General Terms & Conditions. www.ventana.com | www.roche.com iii HOME iv Smart System. Smart Diagnostics. Smart Results. Powering cancer intelligence. 800.227.2155 <PREV NEXT> WORKFLOW SOLUTIONS HOME <PREV NEXT> Workflow Solutions | VENTANA VANTAGE Workflow Solution 3 Workflow Consulting 7 www.ventana.com | www.roche.com 1 HOME 2 <PREV NEXT> VENTANA VANTAGE Workflow Solution | WORKFLOW SOLUTIONS HOME <PREV NEXT> VENTANA VANTAGE Workflow Solution The VENTANA VANTAGE workflow solution is the first of its kind in the industry. Finally, labs can enjoy complete chain of custody, lean integrated processes and full visibility into lab operations any time, from anywhere. Our complete solution for histology labs—hardware, software and Workflow Consulting—offers a commanding view of your complex operation from a single strategic perspective. It is an end-to-end product that automates, streamlines and integrates lab work as well as information flow to provide maximum productivity and to mitigate risks. The VENTANA VANTAGE workflow solution is designed using Lean Six Sigma principles and includes expert Workflow Consulting support to help you obtain immediate and ongoing workflow benefits. What’s on YOUR mind? I need real-time insight to manage my workflow. • See a comprehensive dashboard of lab performance at any time • Identify opportunities for improvement in quality, staffing and efficiency • Facilitate compliance and audit reporting at a moment’s notice I need fast turnaround times and workflow efficiencies. • Partner with lean histology experts to improve your workflow • Introduce lean single piece flow through intuitive touchscreens • Simplify workflow steps, minimise the need for paper and remove non value-added activities I need to eliminate errors and mitigate risk. • Obtain positive specimen identification for all cassettes, blocks and slides, with barcode scanners at each workstation • Immediately locate any patient’s slide, at any point in the process, from any place with internet access • Mitigate errors with “one label, one time” slide identification www.ventana.com | www.roche.com 3 WORKFLOW SOLUTIONS | VENTANA VANTAGE Workflow Solution HOME <PREV Workflow Your integrated workflow management solution Enterprise class software delivers workstation-specific tools to ergonomic touchscreens and integrates with your VENTANA instruments. As your lab processes specimens with the VENTANA VANTAGE workflow solution, sample integrity is verified, comprehensive workflow information is captured and meaningful performance analysis is delivered via dashboards, reports and more. The VENTANA VANTAGE workflow solution is turnkey, can often be implemented rapidly and integrates with the leading Laboratory Information Systems (LIS). Take the stress out of managing your lab’s workflow. With VENTANA VANTAGE, you can focus on the value-added activities that help make your lab successful. Establish complete chain of custody The VENTANA VANTAGE workflow solution brings all of our automated platforms together, creating a complete, unbroken chain of custody that encompasses your entire lab. Locate any specimen, block or slide immediately Ask VENTANA VANTAGE to locate any patient’s slide, on any instrument, at any point in your process—and count on immediate, accurate results. Eliminate redundancies, reduce errors Eliminate data re-entry, relabelling and labelling errors with “one label, one time” technology and barcode scanners at every workstation. Populate patient details accurately Retrieve patient details with a quick barcode scan, expediting review and reducing opportunities for errors. Ordering Information 4 Product Part Number Description VENTANA VANTAGE Workflow Solution For further information, contact local sales representative The VENTANA VANTAGE workflow solution suite is designed to improve productivity and mitigate risks in anatomical pathology. This solution incorporates Lean Six Sigma principles and provides comprehensive specimen tracking, greater quality control and unparalleled informatics. NEXT> VENTANA VANTAGE Workflow Solution | WORKFLOW SOLUTIONS HOME <PREV NEXT> Better together | VENTANA VANTAGE Workflow Consulting adds the power of lean expertise, industry experience and personal attention to the achievement of your laboratory’s goals. www.ventana.com | www.roche.com 5 HOME 6 <PREV NEXT> Workflow Consulting | WORKFLOW SOLUTIONS HOME <PREV NEXT> Workflow Consulting Workflow Consulting empowers today’s highly complex labs to simplify, streamline and succeed. Your partner in Lean automation for years, we are expanding our hands-on services to help you maximise your results and lower your costs. Lean Six Sigma: These are big buzz words in today’s top-performing industries. But the best, most powerful tools in the world are worthless until we learn to use them in our everyday lives. What do the words really mean and how will they help you run your lab at maximum efficiency every day? Our workflow consultants will help you understand and apply Lean principles to address the real-world issues you face in your lab. What’s on YOUR mind? I need fast turnaround times and worflow efficiency. • Standardise your processes to ensure consistent quality outcomes • Optimise your workflow to reduce sample transport time, wait time and waste • Identify where adding VENTANA products can eliminate non-value-added activities I need to eliminate errors and minimise risk. • Locate potential sources of mislabelling and cross contamination in your lab’s workflow • Suggest improvements to accurately track rework and reduce its occurrence • Share best practices and lessons learned I need to improve performance without increasing cost. • Recommend staffing model adjustments to balance your workflow and reduce overtime • Review layout designs that maximise the use of space at your facility www.ventana.com | www.roche.com 7 WORKFLOW SOLUTIONS | Workflow Consulting HOME <PREV Workflow Consulting Our consultants are trained experts in Lean Six Sigma—and they are your biggest advocates as prior lab staff themselves. Our team brings you: Experience Have a tough challenge? We have probably tackled one like it before. Our team has completed more than 125 anatomical pathology lab projects to date all around the world. A typical Workflow Consulting engagement is five days, during which the consultant observes and documents Lean workflow opportunities, compiles findings and shares detailed improvement recommendations with the lab’s leadership and staff. Proven success Our track record for success is proven in many labs worldwide. In fact, one recent customer reports a drop in slide identification errors—from 1.87% slide errors to .00003%—after a workflow assessment and VENTANA VANTAGE installation. Cutting-edge practices We are focused on integrating new technologies, IT systems and hardware with the most efficient workflow to help you reach optimal performance. Partnership Our consultants are your partners in long-term lab improvement, so if you have questions three weeks or three months after the project is complete, we are at your service. Accessioning to archiving Our workflow consultants will partner with you to make your lab’s process easy, fast and reliable. When we look at your lab, we see the big picture. Working closely with your team, we will identify and address the opportunities to optimise your workflow. Optimise your lab’s performance from the moment you receive a sample to the time you deliver a valued patient’s response. 8 NEXT> Workflow Consulting | WORKFLOW SOLUTIONS HOME <PREV NEXT> Better together | Partnered with VENTANA VANTAGE, our total workflow solution (hardware, software and consulting) provides real-time information and reports to help you see how and where you are improving. www.ventana.com | www.roche.com 9 HOME 10 <PREV NEXT> H&E HOME <PREV NEXT> H&E | VENTANA SYMPHONY Fully Automated H&E System 13 Ventana part number in black, Roche item number in blue. www.ventana.com | www.roche.com 11 HOME Ventana part number in black, Roche item number in blue. <PREV NEXT> VENTANA SYMPHONY Fully Automated H&E System | H&E HOME <PREV NEXT> VENTANA SYMPHONY Fully Automated H&E System The VENTANA SYMPHONY automated H&E slide staining platform offers individual slide staining with fresh reagent application for every test, protecting against tissue cross-contamination that occurs in “dipand-dunk” staining baths. Specially designed to enhance lab efficiency, to improve staining quality and to mitigate risks, the VENTANA SYMPHONY system makes the H&E staining process more precise and personal than ever before. What’s on YOUR mind? I need fast turnaround times and workflow efficiency. • Free your technicians to focus on value-added work with one-touch H&E slide processing that delivers true walkaway automation • Optimise lean workflow opportunities with integration of VENTANA VANTAGE workflow solution I need to provide accurate results so physicians can make accurate diagnoses. • Count on consistent, reproducible results throughout the day with fresh reagent application on every slide • Improve diagnostic capability with excellent visualisation of micro-anatomic detail I need to reduce errors and mitigate risk. • Ensure positive patient identification with barcoded patient slides • Protect against cross-contamination with individual slide staining for every patient slide • Reduce technician exposure to toxins with xylene-free VENTANA SYMPHONY Clear Ventana part number in black, Roche item number in blue. www.ventana.com | www.roche.com 13 H&E | VENTANA SYMPHONY Fully Automated H&E System HOME <PREV Specifications General Characteristics Capability • Provides continuous loading of up to 500 slides at a time with throughput of approximately 160-200 slides per hour. Universal Slide tray holds up to 20 individual slides and can be stacked or “nested” for pathologist review. “Slide Detect” ID—slide tracking supporting multiple barcode formats • Simultaneous processing of multiple slide trays including drying, de-paraffinisation, staining and coverslipping Reagents • All VENTANA SYMPHONY solutions are sealed, pre-packaged, ready-to-use and monitored with RFID for inventory management. VENTANA SYMPHONY solutions can be changed “on the fly” without process interruption DI Water Supply • NCCLS type II or type III DI water quality flow of greater than 650 ml/min (22 oz/min) while maintaining a dynamic pressure of greater than 18.9 psi static pressure to 30 psi Communication • Standard category 5, RJ 45 network port, located within 426 cm (14’) of the left side of instrument Network port with TCP/IP ports 80 and 443 open Configuration • Free standing Certifications • CSA (C and US indicators), EMC, CE and C-TICK compliant Features • CareGiver remote support—an automated remote monitoring and diagnostics solution that enables continuous monitoring and remote service • Fresh solutions are used for each slide, resulting in consistent and reproducible results Environmental Requirements Ventilation • The facility ventilation duct should be 7.62 cm (3”) in diameter and be located between 31 cm to 457 cm (1’ and 15’) of instrument. The ventilation flow specification must be a minimum of 35 cfm and a maximum of 70 cfm Liquid Waste Disposal • Location of drain must be within 457 cm (15’) of right side of instrument and not exceed 91 cm (3’) in height Electrical Specifications • Dedicated/isolated 20-amp circuit • 230 ± 10% volts nominal AC, 50/60 Hz - NEMA 6-20R standard receptacle Physical Characteristics Space requirements • • • • Recommended width is greater than 249 cm (98”). This will allow doors to open 180 degrees Height must be greater than 219 cm (86”); (off casters, levelled and ventilated) Depth must be greater than 131 cm (51.5”); this is spaced 13 cm (5") from wall Instrument physical dimensions (H x W x D): 188 cm x 125 cm x 72 cm (74” x 49” x 28”) Ventana part number in black, Roche item number in blue. 14 NEXT> VENTANA SYMPHONY Fully Automated H&E System | H&E HOME <PREV NEXT> Ordering Information Product Part Number Description Quantity VENTANA SYMPHONY Staining System 100799600 06114270001 Fully automated H&E staining platform individually processing patient samples from drying through staining and glass coverslipping. 1 SYMPHONY B 900-204 05279496001 Intended to be used as a bluing reagent. When used in conjunction with SYMPHONY N1 and N2+, SYMPHONY B will change the hue of nuclear staining from purple to blue. 1L box SYMPHONY C 900-202 05279470001 Intended for staining cytoplasmic and other non-nuclear components varying shades of red to pink providing excellent differentiation between collagen, smooth muscle and other eosinophilic structures. 1L box SYMPHONY Clear 900-209 05279518001 Xylene-free solution used for the deparaffinisation and clearing of tissue sections during the staining process. 2L bottle SYMPHONY D 900-210 05279526001 Used for the differentiation of nuclear components stained with SYMPHONY N2+ in regressive staining protocols. 1L box SYMPHONY N1 900-201 05279461001 Intended for staining nuclei and other basophilic cell structures purple to dark purple; used for progressive staining. 1L box SYMPHONY N2+ 900-213 05279542001 Intended for staining nuclei and other basophilic cell structures dark purple to black; used for progressive and regressive staining. 1L box SYMPHONY W 900-203 05279488001 Wash solution used in rinsing steps that occur between aqueous applications during the staining process. 1L box SYMPHONY OPTISURE Glass Coverslips 900-221 05448590001 Specialised glass coverslips applied following the staining and dehydration steps of the VENTANA SYMPHONY staining process to provide enhanced optical clarity and archivability to stained tissue sections. OPTISURE coverslips have a dry mounting medium pre-applied and are packaged in cassettes that are loaded onto the VENTANA SYMPHONY System. 1440 (12 cassettes of 120 coverslips) SYMPHONY N2+ Cleaning Kit 900-217 05279593001 Used for cleaning SYMPHONY N2+ lines. 1 kit SYMPHONY Desiccant Filter 2094800 05258898001 Removes moisture from air, creating optimal humidity within the coverslipping module. 1 filter SYMPHONY Tray Kit (25 mm) 900-301 05279631001 Replacement trays; each tray accomodates 20 slides. 5 trays/pack SYMPHONY Tray Kit (26 mm) 900-311 05279674001 Replacement trays; each tray accomodates 20 slides. 5 trays/pack Better together | Install the VENTANA SYMPHONY stainer with the VENTANA VANTAGE workflow solution for complete chain of custody. Maximise quality with ready-to-use, optimised reagents specially made for use on the VENTANA SYMPHONY. Ventana part number in black, Roche item number in blue. www.ventana.com | www.roche.com 15 HOME Ventana part number in black, Roche item number in blue. 16 <PREV NEXT> HOME <PREV NEXT> Special Stains | VENTANA NexES Special Stains System 19 Special Stains 22 Ancillary Reagents 33 www.ventana.com | www.roche.com 17 HOME Ventana part number in black, Roche item number in blue. 18 18 <PREV NEXT> VENTANA NexES Special Stains System | SPECIAL STAINS HOME <PREV NEXT> VENTANA NexES Special Stains System The VENTANA NexES Special Stains system keeps staining processes consistent and productive. The system offers proven reliability in the field, and new features give you greater staining flexibility. This, in addition to a broad menu of complex and routine special stains, gives you the power to create greater efficiencies. What’s on YOUR mind? I need fast turnaround times and workflow efficiency. • Walkaway automation ensures workflow efficiency • Eliminate time wasted on manual reagent preparation with ready-to-use reagent kits • Improve workflow by freeing your most experienced technicians for value-added tasks • Count on pre-programmed protocol options to get you up and running quickly and keep you operating efficiently week after week I need to provide consistent, high-quality stains so physicians can make accurate diagnoses. • Choose your optimal incubation time and counterstain options for many stains • Select alternate temperature batch mode operation, to improve clarity and workflow for many stains • Eliminate variability from technician-to-technician with quality-controlled reagents • Customise and save your best protocols from a menu of options I need to mitigate risk in my lab. • Reduce technician exposure to harmful chemicals • Ensure correct results with quality-controlled reagent kits www.ventana.com | www.roche.com 19 SPECIAL STAINS | VENTANA NexES Special Stains System HOME <PREV Specifications General Characteristics Capability • Special stains slide processing Slide Carousel • 1–20 slides Reagent Carousel • 25 reagent positions Slides • 25 x 75 mm, 1 x 3 inches or 26 x 76 mm Superfrost Plus Bulk Solutions • 2 bulk solutions DI Water Supply • NCCLS Type II water or equivalent (referred to as deionised water) Temperature Control • 37°C–70°C Modularity • 1–8 VENTANA NexES Special Stains systems may be controlled from one PC Configuration • Bench mounted with 20 liter waste bottle Certifications • CSA and CE compliant Environmental Requirements Heat • 1700 BTU Room Temperature • 15° C to 30° C (59° F to 86° F). Note: The instrument may be unable to maintain proper reaction temperature if laboratory ambient temperature exceeds the specified maximum temperature. Humidity • 5% to 95%, non-condensing Location • Flat, level surface. Remove from sources of direct heat and moisture. Bulk fluid module can be placed up to one metre above or below staining module. Electrical Specifications Voltage • 120/230 VAC ± 10% Current • 5/8 amps Frequency • 50/60 Hz Physical Characteristics Staining Module (SM) Bulk Fluid Module (BFM) Size (W x D x H) • 40.5 cm x 51 cm x 34 cm (16” x 20” x 13.5”) • 34 cm x 37 cm x 34 cm (13.5” x 14.5” x 13.5”) Weight • 18 kg (40 lbs.) • 13.6 kg (30 lbs.) Clearances • Top 38.1 cm (15”) • Sides 10.2 cm (4”) • Rear 15.2 cm (6”) Ventana part number in black, Roche item number in blue. 20 NEXT> VENTANA NexES Special Stains System | SPECIAL STAINS HOME <PREV NEXT> Ordering Information Product Part Number Description VENTANA NexES Special Stains Full System 220V F-SS-950100 05284791001 Fully automated special stains system applying pre-packaged, ready-to-use test kits. Full system order volume includes a) NexES staining module; b) NexES computer system; c) flat screen; d) E-Bar label printer and e) HP printer. VENTANA NexES Special Stains Add-on Module(s) F-SS-950101 05284805001 Fully automated special stains system applying pre-packaged, ready-to-use test kits. Add-on module order volume includes one NexES staining module. VENTANA NexES Special Stains Accessories Product Part Number Description Heavy Metal Extraction System 860-104 05279453001 Heavy Metal Extraction System Vapour Extraction Filter 860-101 05279445001 Vapour Extraction Filter Waste Container with Sealed Cap 1200800 05244820001 Waste Container with Sealed Cap Reagent Tray 1826900 05253578001 Reagent Tray E-Bar II Barcode Slide Label System and Accessories Product E-Bar II Barcode Slide Label System Part Number 1632800 05250862001 Description E-Bar electronic barcode labelling and printing system - printer ~100-240 v, 50/60 Hz. Cable, Parallel Interface Power Cord (US/CAN) Power Cord (INTL) Printer Ribbon, E-Bar Head Cleaning Pen 1347100 1490500 1490100 1632900 1490000 Insert Sheet, Quick Setup Insert Sheet, Ordering Information E-Bar Mylar Shields (5 shields/pkg) Power Supply E-Bar Label Kit E-Bar Label Kit 1418702 05248850001 5 rolls of 500 labels and 5 mylar shields. Printer ribbon not included. E-Bar Printer Ribbon 1632900 05250889001 Prints 8,100 labels. Labels 1358501 05247829001 1 roll of 500 labels. 1490400 1490300 1829000 1490200 1418702 Better together | Maximise your lab’s overall performance—integrate VENTANA NexES Special Stains system easily with the VENTANA BenchMark series of instruments, the VENTANA SYMPHONY individual slide stainer and the VENTANA VANTAGE workflow solution. Ventana part number in black, Roche item number in blue. www.ventana.com | www.roche.com 21 SPECIAL STAINS | Special Stains HOME Special Stains <PREV Stains for Mucins: Alcian Blue, Mucicarmine, PAS, Alcian Blue for PAS, Diastase for PAS, Light Green for PAS Congo Red Tsaining Part Number Control Components/Storage Quantity 860-002 05279186001 Colon Alcian Blue Stain NFR Counterstain 75 tests 15º-30º C 15º-30º C Description Alcian Blue Staining Kit demonstrates weakly acidic mucopolysaccharides. At pH 2.5, Alcian Blue stains sulphated mucins, usually epithelial in origin (and usually PAS-negative), with some occurrences in connective tissue, e.g. in subcutaneous tissue in thyroid deficiency, (myxedema) and in myxomas. It also stains carboxylated sialomucins found in the mucins of submaxillary glands, small intestine and upper colon, and sulphated and carboxylated acid mucopolysaccharides. Some examples of components that stain positive with alcian blue are goblet cells, hyaluronic acid (found in umbilical cord and connective tissue in dermis), salivary glands and gastric lining cells. Alcian Blue (pH 2.5) may be helpful in detecting genetic disorders of acid mucosubstance metabolism and collagen diseases where various acid mucosubstances are increased. The presence of acid mucosubstances tends to decline with advancing age. Mucicarmine Staining Kit Part Number Control Components/Storage Quantity 860-011 05279275001 Bowel Iron Hematoxylin A Iron Hematoxylin B Tartrazine Counterstain Mucicarmine Stain 75 tests 2º-30º C 2º-30º C 2º-30º C 2º-8º C Description Mucicarmine Staining Kit is used to detect acid mucopolysaccharides (mucin). Mucin is a secretion of acid mucopolysaccharides and other substances produced by a variety of epithelial and connective tissue cells. In certain inflammatory processes and certain intestinal carcinomas, epithelial cells secrete excess mucin. Mucicarmine Staining Kit detects mucins of epithelial origin. Fibroblastic or connective tissue mucins may stain poorly. The purpose of this stain is primarily to determine the site of a primary tumour or to distinguish undifferentiated mucin-negative squamous cell lesions from mucin-positive adenocarcinomas. As is the case with current manual stains, mucicarmine stain may not be appropriate for detection of metastatic cancers of the stomach. The stain may also be used as an aid in the identification of Cryptococcus neoformans, a pathogenic fungus containing mucin in its capsule. Carmine and aluminium mordant combine to stain the epithelial mucin a deep rose to red colour. Although the mechanism is not completely understood, it is believed that the aluminium forms a chelate complex with carmine by dye‑like formation, to produce a net positive charge. The complex then attaches to the acid groups of the mucin. Tartrazine Counterstain is applied to provide a contrasting yellow background. Mucin stains deep rose. Cell nuclei stain black. Other tissue elements stain yellow by the counterstain. The capsule of Cryptococcus neoformans stains dark red. Ventana part number in black, Roche item number in blue. 22 NEXT> Special Stains | SPECIAL STAINS HOME PAS Staining Kit Part Number Type Control Components/Storage Quantity <PREV NEXT> 860-014 05279291001 PAS with Hematoxylin Liver 2º-30º C Periodic Acid 2º-30º C Neutralizer 2º-30º C Hematoxylin Counterstain 2º-8º C Schiff’s Reagent (3 vials)* 75 tests *Note: Open only one Schiff’s Reagent vial at a time. Each vial is stable for ONE month after opening. Description PAS Staining Kit is used to demonstrate the presence of glycogen in tissue. PAS-positive reticular fibres, basement membrane, fungus and neutral mucopolysaccharides are also detected. PAS Staining Kit may also be used to aid in distinguishing a PAS-positive, secreting adenocarcinoma from undifferentiated PAS-negative squamous cell carcinoma. PAS Staining Kit uses Periodic Acid to oxidise glycols to aldehydes. Schiff’s Reagent forms a colourless dialdehyde compound that is transformed to the coloured final staining of glycol-containing cellular components. PAS staining in tissue sections and digestion with diastase is useful as an aid in the diagnosis of glycogen storage disease. The PAS Staining Kit stains glycogen bright magenta, with cell nuclei staining light purple. Alcian Blue for PAS Part Number Type Control Components/Storage Quantity 860-003 05279194001 PAS/Alcian Blue Colon Alcian Blue Stain 15º-30º C 75 tests Note: This is not a stand-alone reagent; it must be used in conjunction with PAS Staining Kit. Description Alcian Blue for PAS is an accessory reagent that is used with the PAS Staining Kit. In conjunction with the PAS Staining Kit, acid mucin stains bright blue, while neutral polysaccharides stain bright magenta. Ventana part number in black, Roche item number in blue. www.ventana.com | www.roche.com 23 SPECIAL STAINS | Special Stains HOME Diastase Kit Part Number Type Control Components/Storage Quantity <PREV 860-004 05279208001 Diastase for PAS Liver Diastase 2º-8º C 75 tests Note: This is not a stand-alone reagent; it must be used in conjunction with PAS Staining Kit. Description Diastase is an enzyme which selectively digests (breaks down) glycogen. It is used to remove glycogen from tissue. This produces “negative PAS” staining of the glycogen. Any remaining PAS staining after diastase digestion must be due to non-glycogen protein-bound neutral polysaccharides, such as mucin or fungus. Diastase for PAS is an accessory reagent that is used with the PAS Staining Kit to a) identify glycogen with certainty, by its removal and/or b) eliminate it from the tissue section when it is interfering with the identification of other PAS-positive tissue structures. Because the glycogen is removed, the magenta staining is absent, but the nuclei still stain light purple with the Hematoxylin Counterstain. Light Green for PAS Part Number Type Control Components/Storage Quantity 860-010 05279267001 PAS/Light Green Liver Light Green Counterstain 15º-30º C 75 tests Note: This is not a stand-alone reagent; it must be used in conjunction with PAS Staining Kit. Description Light Green for PAS is an accessory reagent that is used with the PAS Staining Kit. In conjunction with the PAS Staining Kit, fungal elements stain magenta against a light green background. Ventana part number in black, Roche item number in blue. 24 NEXT> Special Stains | SPECIAL STAINS HOME <PREV NEXT> Stains for Connective Tissue: Elastic, Jones, Jones Light Green , Reticulum II, Trichrome II Blue, Trichrome III Blue, Trichrome III Green Elastic Staining Kit Part Number Type Control Components/Storage Quantity 860-005 05279216001 Elastic (Modified Hart’s) Kidney, Lung, Skin Elastic Clarifier Decolorizer Oxidizer Elastic Tissue Stain Van Gieson Solution 75 tests 15º-30º C 15º-30º C 15º-30º C 15º-30º C 15º-30º C Description Elastic Staining Kit demonstrates elastic fibres in tissue sections. Elastic Staining Kit is a modification of Hart’s method for elastic fibres. A resorcin-fuchsin solution is used to stain elastic fibres dark blue or purple to black. Collagen appears pink to red. Van Gieson’s Solution is applied to provide contrasting yellow background tissue. This stain is useful in demonstrating atrophy of elastic tissue in cases of emphysema and the thinning and loss of elastic fibres in arteriosclerosis and other vascular diseases. In normal aorta, a majority of the tissue is elastic and stains dark blue to purple. In kidney, the renal arteries will stain dark blue to purple, while the cortex will stain pink to red. In lung, the pulmonary artery and bronchial walls contain elastin and will stain dark blue to purple. Under high power, the alveoli also demonstrate an intricate meshwork of elastic fibres. The Elastic Staining Kit stains elastic fibres in tissue dark blue‑purple against a yellow background. Collagen in the tissue appears pink to red. Jones H&E Staining Kit Part Number Type Control Components/Storage Quantity 860-019 05279348001 Jones H&E (Hematoxylin and Eosin Counterstains) Kidney 2º-30º C Jones Toner 2º-30º C Jones Fixer 2º-30º C Jones Hematoxylin 2º-30º C Jones Eosin 2º-8º C Jones Periodic Acid 2º-8º C Jones Silver A 2º-8º C Jones Silver B 40 tests Description Jones Staining Kit demonstrates capillary basement membrane and is a modification of Jones Methanamine Silver procedure. Methanamine in this stain is used to demonstrate the carbohydrate component of basement membrane. Periodic acid is used to oxidise carbohydrates to aldehyde groups. Jones Silver A, a silver nitrate solution, provides the silver ions. Jones Silver B provides the alkaline conditions that reduce the silver ions to metallic silver. Toner reagent contains gold chloride to form a more stable gold complex and to remove the yellow tones from the tissue. Fixer, with thiosulfate, stops the reaction and removes any unreduced silver from the section. The purpose of this stain is primarily to distinguish pathological abnormalities in kidney diseases. Hematoxylin and Eosin Counterstains are applied to provide contrasting background. The Jones Staining Kit stains basement membrane black against a light pink background. Basement membranes appear as black ink drawn lines and these fine lines should be seen in the glomeruli of the kidney. Ventana part number in black, Roche item number in blue. www.ventana.com | www.roche.com 25 SPECIAL STAINS | Special Stains HOME <PREV Jones Light Green Staining Kit Part Number Type Control Components/Storage Quantity 860-020 05279356001 Jones (Hematoxylin and Light Green Counterstains) Kidney 2º-30º C Jones Toner 2º-30º C Jones Fixer 2º-30º C Jones Hematoxylin 2º-30º C Jones Light Green 2º-8º C Jones Periodic Acid 2º-8º C Jones Silver A 2º-8º C Jones Silver B 40 tests Description Jones Light Green Kit demonstrates capillary basement membrane and is a modification of Jones Methanamine Silver procedure. Methanamine in this stain is used to demonstrate the carbohydrate component of basement membrane. Periodic acid is used to oxidise carbohydrates to aldehyde groups. Jones Silver A, a silver nitrate solution, provides the silver ions. Jones Silver B provides the alkaline conditions that reduce the silver ions to metallic silver. Toner reagent contains gold chloride to form a more stable gold complex and to remove the yellow tones from the tissue. Fixer, with thiosulfate, stops the reaction and removes any unreduced silver from the section. The purpose of this stain is primarily to distinguish pathological abnormalities in kidney diseases. Hematoxylin and Light Green Counterstain are applied to provide contrasting background. The Jones Light Green Kit stains basement membrane black against a light green background. Basement membrane appear as black ink drawn lines and these fine lines should be seen in the glomeruli of the kidney. Reticulum II Staining Kit Part Number Type Control Components/Storage Quantity 860-024 05279399001 Reticulum (Modified Gordon and Sweets) Liver, Spleen Oxidizer Decolorizer Sensitizer Reticulum II Reducer Toner Fixer II NFR Counterstain Reticulum II Silver A 75 tests 2º-30º C 2º-30º C 2º-30º C 2º-30º C 2º-30º C 2º-30º C 2º-30º C 2º-8º C Description Reticulum II Staining Kit is used to demonstrate reticular fibres. The purpose of this stain is primarily to aid in the differential diagnosis of certain tumour types. In certain tumours, reticulum is located in a characteristic position in relation to the actual tumour cells. Reticulum stains can be used to show disease states in organs such as the liver, spleen and kidney by demonstrating reticular patterns not normal to the organ. In normal liver, the fibres are well-defined strands, but in necrotic or cirrhotic liver, the fibres have discontinuous patterns. Reticulum II Staining Kit is a modification of Gordon and Sweets Stain. Oxidizer, with potassium permanganate, oxidises the tissue to enhance staining of reticular fibres. Decolorizer, with oxalic acid, removes excess potassium permanganate. Sensitizer, with ferric ammonium sulphate, is added to form a metal-organic compound. The metal-organic compound is replaced by the silver in Reticulum II Silver A. Reducer is applied to develop the deposited silver into visible silver. Toner reagent contains gold chloride for better contrast and clarity. Fixer, with thiosulphate, stops the reaction and removes any unreacted silver from the section. Nuclear Fast Red counterstain is applied to provide contrasting background. The Reticulum II Staining Kit stains reticular fibres black against a pink to red background. Ventana part number in black, Roche item number in blue. 26 NEXT> Special Stains | SPECIAL STAINS HOME <PREV NEXT> Trichrome II Blue Staining Kit Part Number Control Components/Storage Quantity 860-013 05279283001 Liver, Kidney, Skin, Colon Bouins Solution Hematoxylin A Hematoxylin B Trichrome Red Trichrome Mordant Trichrome Blue II Trichrome Clarifier 75 tests 15º-30º C 15º-30º C 15º-30º C 15º-30º C 15º-30º C 15º-30º C 15º-30º C Description Trichrome II Staining Kit is used to study connective tissue, muscle and collagen fibres in tissue. Trichrome II Staining Kit is a modification of Masson’s Trichrome Stain. Bouin’s Solution is applied to tissue sections to intensify the final colouration. Cytoplasm and muscle are stained with Trichrome Red, containing Biebrich Scarlet and acid fuchsin. Nuclei are stained with iron hematoxylin. After application of Trichrome Mordant, the collagen is stained with Trichrome Blue, which contains aniline blue. Trichrome Clarifier, an acetic acid solution, is applied to create a more delicate and transparent shade of colour in the tissue section. Trichrome III Blue Staining Kit Part Number Type Control Components/Storage Quantity 860-022 05279364001 Trichrome Blue (Modified Masson’s) Liver, Kidney, Skin, Colon Bouin’s Solution Bouin’s Solution 2 Trichrome III Hematoxylin A Trichrome III Hematoxylin B Trichrome III Enhancer Trichrome III Red Trichrome III Red 2 Trichrome III Mordant Trichrome III Blue Trichrome III Blue 2 75 tests 2º-8º C 2º-8º C 2º-8º C 2º-8º C 2º-8º C 2º-8º C 2º-8º C 2º-8º C 2º-8º C 2º-8º C Description Trichrome III Blue Staining Kit is used to study connective tissue, muscle and collagen fibres. Trichrome III Blue Staining Kit is a modification of Masson’s Trichrome Stain. Bouin’s Solution is applied to tissue sections to intensify the final colouration. Cytoplasm and muscle are stained with Trichrome Red, containing Biebrich scarlet and acid fuchsin. Nuclei are stained with iron hematoxylin. After application of Trichrome III Mordant, the collagen is stained with Trichrome III Blue, which contains aniline blue. The Trichrome III Blue Staining Kit stains collagen blue, muscle and erythrocytes red and cell nuclei blue‑black. Ventana part number in black, Roche item number in blue. www.ventana.com | www.roche.com 27 SPECIAL STAINS | Special Stains HOME <PREV Trichrome III Green Staining Kit Part Number Type Control Components/Storage Quantity 860-023 05279372001 Trichrome Green (Modified Masson’s) Liver, Kidney, Skin, Colon Bouin’s Solution Bouin’s Solution 2 Trichrome III Hematoxylin A Trichrome III Hematoxylin B Trichrome III Enhancer Trichrome III Red Trichrome III Red 2 Trichrome III Mordant Trichrome III Green Trichrome III Green 2 75 tests 2º-8º C 2º-8º C 2º-8º C 2º-8º C 2º-8º C 2º-8º C 2º-8º C 2º-8º C 2º-8º C 2º-8º C Description Trichrome III Green Staining Kit is used to study connective tissue, muscle and collagen fibres. Trichrome III Green Staining Kit is a modification of Masson’s Trichrome Stain. Bouin’s Solution is applied to tissue sections to intensify the final colouration. Cytoplasm and muscle are stained with Trichrome Red, containing Biebrich scarlet and acid fuchsin. Nuclei are stained with iron hematoxylin. After application of Trichrome III Mordant, the collagen is stained with Trichrome III Green, which contains fast green FCF. The Trichrome III Green Staining Kit stains collagen green, muscle and erythrocytes red and cell nuclei blue to black. Ventana part number in black, Roche item number in blue. 28 NEXT> Special Stains | SPECIAL STAINS HOME <PREV NEXT> Stains for Micro-Organisms: AFB III, Alcian Yellow, GMS II, Steiner AFB III Staining Kit Part Number Type Control Components/Storage Quantity 860-027 05279437001 Acid-Fast Bacillus (Modified Ziehl-Neelson) Tissue positive for acid-fast bacteria 15º-30º C AFB Stain 15º-30º C AFB Decolorizer II 15º-30º C AFB III Blue 75 tests Description AFB III Staining Kit is used to selectively demonstrate mycobacterium and other acid fast organisms and components in tissue. AFB III Staining Kit is a modification of the Ziehl-Neelsen stain. A carbol fuchsin solution is used to stain acid fast organisms and components red. Aniline blue counterstain is applied to provide contrasting blue background. Alcian Yellow Staining Kit Part Number Control Components/Storage Quantity 860-017 05279321001 Gastric tissue positive for H. pylori 2º-8º C Alcian Yellow Toluidine Blue 2º-8º C Alcian Yellow Sensitizer 2º-8º C Alcian Yellow Oxidizer 2º-8º C Alcian Yellow Stain 2º-8º C Alcian Yellow Clarifier (3 vials*) 75 tests *Note: Open only one Alcian Yellow Clarifier vial at a time. Each vial is stable for ONE month after opening. Description Helicobacter pylori is a gram negative bacterium that has been shown to be the causative organism in some gastric and duodenal ulcers. It is the most common cause of antral gastritis and has been linked to the development of the distal gastric carcinoma and low grade gastric lymphoma. Helicobacter pylori has been shown to survive in the acid environment of the stomach and is able to destroy the neutral mucin that the surface epithelial cells secrete. Identification in a gastric biopsy and prompt treatment with antibiotics can lead to a fast recovery for the patient. Alcian Yellow Staining Kit stains the Helicobacter pylori blue, the background blue and the mucin yellow. Ventana part number in black, Roche item number in blue. www.ventana.com | www.roche.com 29 SPECIAL STAINS | Special Stains HOME GMS II Staining Kit Part Number Type Control Components/Storage Quantity <PREV 860-028 05412749001 Gomori’s Methanamine Silver (Modified) Tissue positive for fungi or Pneumocystis carinii 2º-30º C Oxidizer 2º-30º C Neutralizer 2º-30º C Toner 2º-30º C Fixer 2º-30º C Light Green Counterstain 2º-8º C GMSII Silver A 2º-8º C GMSII Silver B (2 vials) 75 tests Description GMS II Staining Kit selectively demonstrates polysaccharides in the cell walls of fungi and other opportunistic organisms, such as Pneumocystis carinii. GMS Staining Kit is a modification of Gomori’s Methanamine Silver procedure. Tissue, fungal and microbial cell wall polysaccharides are oxidised to aldehyde groups by GMS Oxidizer. Chromic acid suppresses weaker background staining of collagen fibres and basement membranes. Neutralizer removes excess chromic acid. GMS Silver A, a silver nitrate reagent, provides the silver ions. GMS Silver B provides the alkaline conditions that reduce the silver ions to metallic silver. Toner reagent contains gold chloride to form a more stable gold complex and remove the yellow tones from the tissue. Fixer, with thiosulphate, stops the reaction and removes any unreduced silver from the section. The purpose of this stain is primarily to distinguish pathogenic fungi, such as Aspergillus and Blastomyces as well as other opportunistic organisms, such as Pneumocystis carinii in tissue sections. Light Green Counterstain is applied to provide contrasting background. The GMS Staining Kit stains fungus black against a light green background. Aspergillus hyphae appear as black filaments. Pneumocystis carinii organisms appear as clusters of helmet-shaped black spots. Steiner Staining Kit Part Number Control Components/Storage Quantity 860-018 05279330001 Tissue positive for H. pylori, Cat Scratch, Spirochetes, Legionella, 2º-8º C Steiner Diffuser 2º-8º C Steiner Enhancer 2º-8º C Steiner Reducer 2º-8º C Steiner Silver 2º-8º C Steiner Diluent 40 tests Description Steiner Staining Kit is used to aid in the identification of causative organisms of infection such as spirochetes, Legionella pneumophilia, Helicobacter pylori and other bacteria. Organisms will stain dark brown to black. Background will stain golden yellow to amber. Other tissue elements stain golden yellow to amber; nuclei will stain amber to dark brown. Steiner Cleaning Kit Part Number Components/Storage Quantity 860-025 05279402001 Steiner Clean ambient Probe Cleaning Solution ambient 10 runs Note: Steiner Cleaning Kit must be ordered with the Steiner Staining Kit. It is a critical component for proper functioning of the VENTANA NexES Special Stains automated slide stainer Description Steiner Cleaning Kit is an accessory required for use with the Steiner Staining Kit. The Steiner Cleaning Kit is an alcohol solution that is used to prevent and remove build-up of gum mastic residue from the VENTANA NexES Special Stains automated slide stainer that is deposited during the Steiner assay. Ventana part number in black, Roche item number in blue. 30 NEXT> Special Stains | SPECIAL STAINS HOME <PREV NEXT> Other Special Stains: Congo Red, Giemsa, Iron Congo Red Staining Kit Part Number Control Components/Storage Quantity 860-026 05279429001 Tissue positive for Amyloid Congo Red Stain Glycine Buffer Congo Red Hematoxylin 40 tests 2º-8º C 2º-8º C 2º-8º C Description Congo Red Staining Kit is used to selectively demonstrate amyloid in tissue sections. The staining reaction is based on the application of congo red which stains the patterns of atypical proteins (amyloid). The b-pleated sheets of amyloid are suitable in size and shape to accommodate the congo red molecules, which are held in the lattice work of the b-pleated sheets. Birefringence is an intrinsic property of the amyloid fibril congo red complex. Congo red may also stain unexpected structures such as: keratin, elastic and dense collagen fibres. Without both the red staining of congo red and the apple green birefrengence under polarisation a definite identification cannot be made. The hematoxylin is applied as a contrasting blue nuclear stain. The Congo Red Staining Kit stains amyloid a bright pink to red and nuclei blue. Amyloid may appear as circular or ribbon-like pink staining deposits throughout the tissue. It has a particular predilection for deposition in blood vessel walls and basement membranes. Nuclear staining may vary from light to dark blue depending on the tissue section and thickness (6-10 microns). Giemsa Staining Kit Part Number Control Components/Storage Quantity 860-006 05279224001 Bone Marrow Giemsa Stain 75 tests 15º-30º C Description Giemsa Staining Kit differentiates leucocytes in bone marrow and other hematopoietic tissue (lymph nodes). The stain can also be used to demonstrate some micro-organisms, such as H. pylori. A buffered thiazine-eosinate solution is used to stain cells differentially with a characteristic blue or pink colour. The Giemsa Staining Kit stains leucocytes purple, erythrocytes pink and mast cells and many other cell types characteristically blue. Nuclei stain red to purple. The pathogenic gram-negative spiral bacteria, H. pylori, stains blue. Ventana part number in black, Roche item number in blue. www.ventana.com | www.roche.com 31 SPECIAL STAINS | Special Stains HOME Iron Staining Kit Part Number Control Components/Storage Quantity 860-009 05279259001 Liver Iron Reagent A Iron Reagent B Nuclear Fast Red Counterstain 75 tests <PREV 15º-30º C 15º-30º C 15º-30º C Description Iron Staining Kit detects the presence of ferric iron in tissue. The iron is separated from protein by hydrochloric acid. The free ferric iron reacts with the potassium ferrocyanide to form an insoluble bright blue ferric ferrocyanide or Prussian blue. A Nuclear Fast Red counterstain is applied to provide a pink to red contrasting background. Iron pigment stains bright blue. Heavy deposits of iron appear dark blue. Cytoplasm stains pink and nuclei stain pink to red. Ventana part number in black, Roche item number in blue. 32 NEXT> Ancillary Reagents | SPECIAL STAINS HOME <PREV NEXT> Ancillary Reagents Product Part Number Description Quantity Special Stains Wash Solution (10x) 860-015 05279305001 Special Stains Wash Solution is used to dilute the special stains reagents that are dispensed onto the slide and to wash the slides in between reagent applications on the VENTANA NexES Special Stains automated slide stainer. It is used at a 1X concentration and therefore requires a 1:10 dilution prior to use. The quality of the water used to prepare the Special Stains Wash Solution is critical to obtaining proper staining results. De-ionised water is recommended for its preparation. 2L bottle (concentrate) Liquid Coverslip (Low Temperature) 250-009 05260981001 Liquid Coverslip is applied atop aqueous reagents by the VENTANA NexES Special Stains automated slide stainer to prevent reagent evaporation and ensure complete slide coverage. 2L bottle (ready to use) Special Stains Cleaning Kit 860-016 05279313001 The Special Stains Cleaning Kit is used to neutralise and clean the reagent aspiration and dispense mechanism of the VENTANA NexES Special Stains system and prevent reagent carry-over. It is recommended to perform a cleaning run at the end of each workday and after each Trichrome III Blue or Trichrome III Green run. Components: Cleaning Solution A, Cleaning Solution B, Cleaning Solution C 50 cleaning cycles Sections AFB Alcian Blue Alcian Yellow Congo Red 3-5µm 4µm 3-5µm 6-10µm Elastic Giemsa GMS Iron 4µm 4µm 4µm 4µm Jones and Jones LG Mucicarmine PAS/Diastase PAS/Alcian Blue 2-4µm 4µm 4µm 4µm PAS Reticulum Steiner Trichrome 4µm 2-5µm sections < 4µm may cause light or broken fibres 5µm for tissue sections (< 5μm may cause light and pale staining) 2-3µm for biopsies (kidney/liver) Water Quality Type I Type II Type III Conductivity at 25º C (microohms/cm) 0.1 1.0 10 Resistivity at 25º C (megaohms-cm) 10 1.0 0.1 Silicate (mg/L Si02) 0.05 0.1 1.0 pH — — 5.0-8.0 Bacteria Growth (cfu/mL) 10 (preferably bacteria free) 1000 n/a Particulate Matter 0.22 mm filter n/a n/a Organics activated carbon n/a n/a Ventana part number in black, Roche item number in blue. www.ventana.com | www.roche.com 33 HOME Ventana part number in black, Roche item number in blue. 34 <PREV NEXT> IHC & ISH HOME <PREV NEXT> IHC & ISH | VENTANA BenchMark ULTRA System 37 VENTANA BenchMark XT System 41 VENTANA BenchMark GX System 45 Detection Chemistries 49 Primary Antibodies by disease state 55 Primary Antibodies by alphabetical listing 68 Immunofluorescence Antibodies 179 Research Antibodies 183 Molecular Probes 185 Ancillary Reagents 193 Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 35 HOME Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). <PREV NEXT> VENTANA BenchMark ULTRA | IHC & ISH HOME <PREV NEXT> VENTANA BenchMark ULTRA Multi-Modal Slide-Staining System The VENTANA BenchMark ULTRA system is the next generation in IHC/ISH staining instrumentation. Using 30 individual slide processors, its patient-centred workflow integrates multi-modal access for real-time STAT processing. Turnaround times are significantly reduced resulting in faster reporting of patient results, hence giving the next generation in lean laboratory workflow. The VENTANA BenchMark ULTRA is the first multi-modal system to perform simultaneous IHC and ISH testing on a single and random access platform. Multi-parameter testing such as dual and triple stains may be performed independently of other slides, allowing rapid results. The VENTANA BenchMark ULTRA system is optimised for a full range of ready-to-use immunohistochemical reagents, as well as for a variety of in situ hybridisation tests, simplifying complex molecular testing into a routine automated procedure. The VENTANA BenchMark ULTRA system can be linked to the existing Laboratory Information System (LIS) to manage information from a single computer to increase workflow efficiency and patient safety. Proprietary flexible hardware and software • 30 independently functioning slide staining chambers preserve sample integrity and eliminate the need for batch processing • Add or remove individual slides at any time • Access reagents at frequent intervals • Run unexpected test requests as STAT without interrupting cases already in process • Count on visual and audio alerts to signal access to slides and reagents • Reagent Detect Sensor quickly and accurately reads added reagent Immediately process STAT and late-arriving samples • Quickly respond to unexpected test requests without impacting other cases in process • Efficiently add reagents as needed to enable immediate processing • Ensure fast delivery of slides to pathologists visual instrument interface Provide consistent high-quality stains • Optimise antibody and probe performance with enhanced protocol flexibilities • Efficiently process dual and triple IHC stains • Deploy next-generation molecular tissue testing today Eliminate bottlenecks • Add samples throughout the day to eliminate the need to batch slides • Extend test order cut-off times, improving throughput and productivity all day • Free technicians’ time for value-added tasks using lean workflow processes Improve turnaround times and efficiency • Deliver fast turnaround times with Lean Six Sigma “single piece flow” processing • Process all slides in each patient’s case together to eliminate sorting • See the exact status of patient samples with an intuitive visual instrument interface * 2009 Medical Design Excellence Award www.ventana.com | www.roche.com 37 IHC & ISH | VENTANA BenchMark ULTRA HOME Specifications <PREV General Characteristics Fully Automated • Baking, deparaffinisation, cell conditioning and staining, including IHC , ISH, SISH, Dual ISH, immunofluorescence, multiparameter IHC staining (dual, triple), counterstain and titration Slide Position • 1–30 slides with independent processing/functionality and temperature control for each position Reagent Carousel • 35 reagent positions Slides • 25 x 75 mm, 1 x 3 inches or 26 x 76 mm Superfrost Plus Bulk Solutions • Up to 7 different bulk solutions can be changed “on the fly” without process interruption Waste • Two – 20 litre carboys, can be changed “on the fly” without process interruption DI Water Supply • NCCLS Type II water or equivalent (deionised water) Temperature Control • Ambient to 100ºC Modularity • One to eight VENTANA BenchMark ULTRA (and/or VENTANA Discovery ULTRA) staining systems may be controlled from one VENTANA BenchMark ULTRA computer system Configuration • Free standing Certifications • CSA Features • Automated IHC/ISH platform manages STAT requests with no impact to in-process slides • Superior throughput – 90 slides per 8 hour shift • Enhanced protocol flexibilities Environmental Requirements Heat • 400 BTU/Hr idle, 1000 BTU/Hr running Room Temperature • 20ºC to 32ºC (68ºF to 90ºF) Humidity • 10% to 90%, non-condensing Electrical Specifications Voltage • ~ 230-240 / 100-120 V Current • 4/6 amps Frequency • 60/50 Hz Physical Characteristics Size (W x D x H) • 111.76 cm x 84.07 cm x 158.50 cm (44.00” x 33.10” x 62.40”) Weight • 294.8 kg (650 lbs.) Clearances • Top 38.1 cm (15”) • Sides 10.2 cm (4”) • Rear 15.2 cm (6”) Better together | Install the VENTANA BenchMark ULTRA stainer with the VENTANA VANTAGE workflow system for complete specimen tracking. Maximise stain quality with enhanced protocol flexibilities exclusive to the VENTANA BenchMark ULTRA. The products that appear on this page are IVD (for in vitro diagnostic use). 38 NEXT> VENTANA BenchMark ULTRA | IHC & ISH HOME <PREV NEXT> Ordering Information Product VENTANA BenchMark ULTRA Full System Part Number Description F-BKU-750 000 05465079001 750-602 F-ISH-200 001 F-IHC-250 005 750-600 1697400 2505700 322-001 05342724001 05280907001 05280893001 05342716001 05425485001 05424577001 05263212001 Part Number Description Full System, 220 V Computer System Flat Screen Monitor Printer Staining Module Accessory Kit #1 Accessory Kit #2 Power Strip 1632800 1358501 1650800 1196700 06376525001 F-IHC-200 000 05250862001 05247829001 05250986001 05244676001 06376525001 05287693001 E-Bar II Barcode Slide Label System Blank Flap-Label Roll Waste Container and Cart (20L) Graduated Carboy (20L) Bottle Ship Kit Multi-Plug 6 Positions Continental 1650800 1196700 06376525001 F-IHC-200 000 05250986001 05244676001 06376525001 05287693001 Waste Container and Cart (20L) Graduated Carboy (20L) Bottle Ship Kit Multi-Plug 6 Positions Continental VENTANA BenchMark ULTRA Add-on Module F-BKU-750 001 05465117001 750-600 1697400 2505700 322-001 05342716001 05425485001 05424577001 05263212001 Staining Module Accessory Kit #1 Accessory Kit #2 Power Strip VENTANA Lab Manager, System Disk (For Central Management Capability) 2105200 05259002001 This networked software product provides single-point management of multiple advanced staining systems. Customers with multiple hosts can share reagents and protocols. Singlehost customers can add a second host and start mulitiple runs at the same time. VENTANA Interface Point, System Disk (For VENTANA LIS Connectivity Capability) 1364000 05247861001 This networked product provides an interface between the VENTANA staining system and the laboratory information system (LIS). The interface automates data entry at the stainer and also provides for automatic status updates back to the LIS. Add-on Module, 220 V VENTANA BenchMark Series Accessories Product Part Number Description Dispenser Rack 321-044 06265553001 Reagent dispenser storage rack — grey Graduated Carboy 1196700 05244676001 20L receptacle for storage of diluted bulk solutions Temperature Verifier 970-021 Slides (10) 05424615001 Used for independent testing of slide heater function; 10 slides Waste Cart BMK 06141960001 Rolling cart used to hold waste container on VENTANA BenchMark series instruments 1488000 E-Bar II Barcode Slide Label System and Accessories Product Part Number Description E-Bar II Barcode Slide Label System 1632800 05250862001 E-Bar electronic barcode labelling and printing system - printer ~100-240 v, 50/60 Hz. E-Bar Label Kit 1418702 05248850001 5 rolls of 500 labels and 5 mylar shields. Printer ribbon not included. E-Bar Printer Ribbon 1632900 05250889001 Prints 8,100 labels. Labels 1358501 05247829001 1 roll of 500 labels. Cable, Parallel Interface Power Cord (US/CAN) Power Cord (INTL) Printer Ribbon, E-Bar Head Cleaning Pen 1347100 1490500 1490100 1632900 1490000 Insert Sheet, Quick Setup Insert Sheet, Ordering Information E-Bar Mylar Shields (5 shields/pkg) Power Supply E-Bar Label Kit 1490400 1490300 1829000 1490200 1418702 Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 39 HOME Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 40 Intelligent Systems. Intelligent Diagnostics. Intelligent Results. <PREV NEXT> VENTANA BenchMark XT | IHC & ISH HOME <PREV NEXT> VENTANA BenchMark XT Automated Slide Processing System The VENTANA BenchMark XT system offers the flexibility needed to expand your test menu, process more slides and improve your turnaround times. Our fully automated random-access platform can simultaneously run IHC and ISH tests, allowing you to process all patient cases in a single run. What’s on YOUR mind? I need faster turnaround times and greater efficiency. • Increase your slide throughput by 25% and eliminate up to 80% of manual tasks (compared to manual and semiautomated staining processes) I need to provide consistent high-quality stains so physicians can make accurate diagnoses. • Improve consistency and reproducibility for IHC, ISH and FITC applications on a fully automated platform with precisely controlled, baking-through-staining technology I need to free technicians’ time for value-added work. • Eliminate manual steps associated with baking, deparaffinisations and antigen retrieval with walkaway automation • Simplify IHC and ISH processing through barcodedriven technology, coupled with pre-diluted antibodies and probes I need to mitigate risk and reduce errors in my lab. • Eliminate the potential for errors with barcode-driven technology that match protocols and reagents to patient slides I need greater flexibility. • Process your IHC, ISH and FITC steps independently or simultaneously • Optimise your protocols with flexible options including variable incubation times and temperatures www.ventana.com | www.roche.com 41 IHC & ISH | VENTANA BenchMark XT Specifications HOME <PREV General Characteristics Fully Automated • Baking, deparaffinisation, cell conditioning and staining, including IHC, ISH, SISH, Dual ISH, immunofluorescence, multiparameter IHC (dual, triple), counter stain and titration Slide Tray BenchMark XT • 1-30 slides with independent temperature control for each position Reagent Carousel • 35 reagent positions Slides • 25 x 75 mm, 1 x 3 inches or 26 x 76 mm Superfrost Plus Bulk Solutions • Up to 7 different bulk solutions in 3 to 6-litre on-board containers DI Water Supply • NCCLS Type II water or equivalent (referred to as deionised water) Temperature Control • 37° C to 100° C ± 2.0° C Modularity • One to eight VENTANA BenchMark XT, VENTANA BenchMark GX, VENTANA NexES Special Stains or VENTANA Discovery systems may be controlled from one PC (excluding VENTANA BenchMark ULTRA) Configuration • Free standing Certifications • CSA Unique Features • Fully automated, baking-through-staining technology • 90 slides per 8–hr. shift • Random-access platform – process ISH and IHC simultaneously Environmental Requirements Heat • 400 BTU/Hr idle, 1000 BTU/Hr running Room Temperature • 20ºC to 32ºC (68ºF to 90ºF) Humidity • 10% to 90%, non-condensing Electrical Specifications Voltage • ~ 230-240 / 100-120 V Current • 4/6 amps Frequency • 60/50 Hz Physical Characteristics Size (W x D x H) • 88.9 cm x 66.0 cm x 153.0 cm (35” x 26” x 60.25”) Weight • 175 kg (385 lbs.) Clearances • Top 38.1 cm (15”) • Sides 10.2 cm (4”) • Rear 15.2 cm (6”) Better together | Ordering Information Install the VENTANA BenchMark XT platform with the VENTANA VANTAGE workflow system for complete chain of custody. Maximise stain quality with prediluted, optimised reagents specially made for use on the VENTANA BenchMark XT. The products that appear on this page are IVD (for in vitro diagnostic use). 42 NEXT> VENTANA BenchMark XT | IHC & ISH Ordering Information Product Part Number HOME Description Part Number <PREV NEXT> Description VENTANA BenchMark XT Full system F-BXT-750 000 05281229001 Full System, 220 V 750-012 F-ISH-200 001 F-IHC-250 005 750-700 1963500 1981600 05264979001 05280907001 05280893001 05265231001 05256146001 05256577001 Computer System Flat Screen Monitor Printer Staining Module Accessory Kit #1 Accessory Kit #2 VENTANA BenchMark XT Add-on Module F-BXT-750 001 05281237001 Add-on Module, 220 V 750-700 1963500 1981600 322-001 05265231001 05256146001 05256577001 05263212001 Staining Module Accessory Kit #1 Accessory Kit #2 Power Strip IHC VENTANA BenchMark XT Application F-BXT-750 701 05281245001 Software ISH VENTANA BenchMark XT Application F-BXT-750 702 05281253001 Software VENTANA Lab Manager, System Disk (For Central Management Capability) 2105200 05259002001 This networked software product provides single-point management of multiple advanced staining systems. Customers with multiple hosts can share reagents and protocols. Singlehost customers can add a second host and start mulitiple runs at the same time. VENTANA Interface Point, System Disk (For VENTANA LIS Connectivity Capability) 1364000 05247861001 This networked product provides an interface between the VENTANA staining system and the laboratory information system (LIS). The interface automates data entry at the stainer and also provides for automatic status updates back to the LIS. 322-001 1632800 1358501 1650800 1196700 F-IHC-200 000 06376517001 05263212001 05250862001 05247829001 05250986001 05244676001 05287693001 06376517001 Power Strip E-Bar II Barcode Slide Label System Blank Flap-Label Roll Waste Container and Cart (20L) Graduated Carboy (20L) Multi-Plug 6 Positions Continental Bottle Ship Kit, BenchMark XT/LT F-IHC-200 000 06376517001 1650800 1196700 05287693001 06376517001 05250986001 05244676001 Multi-Plug 6 Positions Continental Bottle Ship Kit, BenchMark XT/LT Waste Container and Cart (20L) Graduated Carboy (20L) VENTANA BenchMark Series Accessories Product Part Number Description Dispenser Rack 321-044 06265553001 Reagent dispenser storage rack — grey Graduated Carboy 1196700 05244676001 20L receptacle for storage of diluted bulk solutions Temperature Verifier 970-021 Slides (10) 05424615001 Used for independent testing of slide heater function; 10 slides Waste Cart BMK 06141960001 Rolling cart used to hold waste container on VENTANA BenchMark series instruments 1488000 E-Bar II Barcode Slide Label System and Accessories Product Part Number Description E-Bar II Barcode Slide Label System 1632800 05250862001 E-Bar electronic barcode labelling and printing system - printer ~100-240 v, 50/60 Hz. E-Bar Label Kit 1418702 05248850001 5 rolls of 500 labels and 5 mylar shields. Printer ribbon not included. E-Bar Printer Ribbon 1632900 05250889001 Prints 8,100 labels. Labels 1358501 05247829001 1 roll of 500 labels. Cable, Parallel Interface Power Cord (US/CAN) Power Cord (INTL) Printer Ribbon, E-Bar Head Cleaning Pen 1347100 1490500 1490100 1632900 1490000 Insert Sheet, Quick Setup Insert Sheet, Ordering Information E-Bar Mylar Shields (5 shields/pkg) Power Supply E-Bar Label Kit 1490400 1490300 1829000 1490200 1418702 Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 43 HOME Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 44 Intelligent Systems. Intelligent Diagnostics. Intelligent Results. <PREV NEXT> VENTANA BenchMark GX | IHC & ISH HOME <PREV NEXT> VENTANA BenchMark GX Automated Slide Processing System The VENTANA BenchMark GX automated slide preparation system offers the flexibility you need to expand your test menu, process more slides and improve your turnaround times. Best of all, this sophisticated and elegant solution empowers you to manage multiple systems from a single computer. Quality Enhance staining quality, consistency and reproducibility in a controlled, kinetically optimised reaction environment. Productivity Experience the benefits of walk away automation, increase your slides-per-hour performance by up to 25% and eliminate up to 80% of manual tasks. Flexibility Automate any or all slide preparation steps, from baking through counterstaining. Process your SISH, IHC, ISH or FITC slides and optimise your protocols with flexible options. set-up set-up baking through counterstaining baking through counterstaining VENTANA BenchMark GX Slide Preparation System run 1 0 1 2 Slide Stainer Only run 2 3 4 5 6 7 8 8 hr. shift run 1 set-up cell conditioning (epitope retrevial) dewax baking staining counterstaining www.ventana.com | www.roche.com 45 IHC & ISH | VENTANA BenchMark GX HOME <PREV Specifications General Characteristics Fully Automated • Baking, deparaffinisation, cell conditioning and staining, including IHC, ISH, SISH, Dual ISH, immunofluorescence, multiparameter IHC (dual, triple), counter stain and titration Slide Tray BenchMark GX • 1-20 slides with independent temperature control for each position Reagent Carousel • 25 reagent positions Slides • 25 x 75 mm, 1 x 3 inches or 26 x 76 mm Superfrost Plus Bulk Solutions • Up to 7 different bulk solutions in 3 to 6-litre on-board containers DI Water Supply • NCCLS Type II water or equivalent (referred to as deionised water) Temperature Control • 37° C to 95° C ± 2.0° C Modularity • One to eight VENTANA BenchMark GX, VENTANA BenchMark XT, VENTANA NexES Special Stains or VENTANA Discovery systems may be controlled from one PC (excluding VENTANA BenchMark ULTRA) Configuration • Free standing Certifications • CSA Unique Features • Fully automated, baking-through-staining technology • 60 slides per 8–hr. shift Environmental Requirements Heat • 1200 BTU/Hr running Room Temperature • 15ºC to 30ºC (64ºF to 86ºF) Humidity • 10% to 90%, non-condensing Electrical Specifications Voltage • ~ 200-240 / 100-120 V Current • 2/4 amps Frequency • 60/50 Hz Physical Characteristics Size (W x D x H) • Staining Module: 40.5 cm x 54.6 cm x 34.0 cm (16” x 21.5” x 13.5” ) • Automated Fluidics Module: 50.8 cm x 54.6 cm x 38.1 cm (20” x 21.5” x 15” ) • Base Cabinet Module: 50.8 cm x 54.6 cm x 52.1 cm (20” x 21.5” x 20.5” ) Weight • Staining Module: 25 kg (55 lbs.) • Automated Fluidics Module: 26.4 kg (58 lbs.) • Base Cabinet Module: 13.6 kg (30 lbs.) Clearances • Top 38.1 cm (15”) • Sides 10.2 cm (4”) • Rear 15.2 cm (6”) The products that appear on this page are IVD (for in vitro diagnostic use). 46 NEXT> VENTANA BenchMark GX | IHC & ISH HOME <PREV NEXT> Ordering Information Product VENTANA BenchMark GX Full System VENTANA BenchMark GX Add-on Module Part Number Description Part Number Description Full System, 220 V 750-012 F-ISH-200 001 F-IHC-250 005 750-850 750-861 750-872 100761200 0564979001 05280907001 05280893001 05894662001 05894638001 05894654001 05894689001 Computer System Flat Screen Monitor Printer Staining Module AFM Waste Module Drawer 322-001 1632800 1358501 1650800 F-IHC-200 000 750-ACC 05865379001 1196700 05263212001 05250862001 05247829001 05250986001 05287693001 05266017001 05865379001 05244676001 Power Strip E-Bar II Slide Label System Blank Flap- Label Roll Waste Container and Cart (20L) Multi-Plug 6 Positions Continental Accessory Kit Bottle Ship Kit Graduated Carboy (20L) 1650800 F-IHC-200 000 750-ACC 05865379001 1196700 05250986001 05287693001 05266017001 05865379001 05244676001 Waste Container and Cart (20L) Multi-Plug 6 Positions Continental Accessory Kit Bottle Ship Kit Graduated Carboy (20L) Add-on Module, 220 V 750-850 750-861 750-872 100761200 05894662001 05894638001 05894654001 05894689001 Staining Module AFM Waste Module Drawer VENTANA Lab Manager, System Disk (For Central Management Capability) 2105200 05259002001 This networked software product provides single-point management of multiple advanced staining systems. Customers with multiple hosts can share reagents and protocols. Singlehost customers can add a second host and start mulitiple runs at the same time. VENTANA Interface Point, System Disk (For VENTANA LIS Connectivity Capability) 1364000 05247861001 This networked product provides an interface between the VENTANA staining system and the laboratory information system (LIS). The interface automates data entry at the stainer and also provides for automatic status updates back to the LIS. VENTANA BenchMark Series Accessories Product Part Number Description Dispenser Rack 321-044 06265553001 Reagent dispenser storage rack — grey Graduated Carboy 1196700 05244676001 20L receptacle for storage of diluted bulk solutions Temperature Verifier 970-021 Slides (10) 05424615001 Used for independent testing of slide heater function; 10 slides Waste Cart BMK 06141960001 Rolling cart used to hold waste container on VENTANA BenchMark series instruments 1488000 E-Bar II Barcode Slide Label System and Accessories Product Part Number Description E-Bar II Barcode Slide Label System 1632800 05250862001 E-Bar electronic barcode labelling and printing system - printer ~100-240 v, 50/60 Hz. E-Bar Label Kit 1418702 05248850001 5 rolls of 500 labels and 5 mylar shields. Printer ribbon not included. E-Bar Printer Ribbon 1632900 05250889001 Prints 8,100 labels. Labels 1358501 05247829001 1 roll of 500 labels. Cable, Parallel Interface Power Cord (US/CAN) Power Cord (INTL) Printer Ribbon, E-Bar Head Cleaning Pen 1347100 1490500 1490100 1632900 1490000 Insert Sheet, Quick Setup Insert Sheet, Ordering Information E-Bar Mylar Shields (5 shields/pkg) Power Supply E-Bar Label Kit 1490400 1490300 1829000 1490200 1418702 Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 47 HOME <PREV Let CareGiver safeguard your lab Now available for VENTANA BenchMark ULTRA and VENTANA SYMPHONY instruments, CareGiver remote system performance monitoring protects your lab 24/7 with four fool-proof safeguards: 1. Reduce costly down time with remote troubleshooting, plus predictive intelligence that identifies potential problems before they occur 2. Reduce cost of service with proactive preventive maintenance planning and ability to proactively diagnose and solve existing and potential issues 3. Easily access industry experts with CareGiver using desktop sharing for application support and user training 4. Receive timely and convenient software upgrades with convenient remote deployment that minimises disruptions to your workflow 48 Intelligent Systems. Intelligent Diagnostics. Intelligent Results. NEXT> Detection Chemistries | IHC & ISH HOME <PREV NEXT> Detection Chemistries AEC Detection Chemistry AEC Detection Kit Part Number Quantity Status Components 760-020 05266041001 250 tests IVD Inhibitor Biotinylated lg Streptavidin HRP AEC AEC H202 IHC ISH Description Basic AEC Detection Kit is an indirect biotin streptavidin system for detecting mouse and rabbit primary antibodies. The kit is intended for use with formalin-fixed, paraffin-embedded tissue or frozen tissue. The AEC chromogen produces a dark red precipitate that is readily detected by light microscopy. All reagents are provided pre-diluted and ready-to-use for convenient operation on VENTANA BenchMark series automated slide stainers. Note: The AEC depositions are soluble in organic solvents. Aqueous mounting medium should be used. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 49 IHC & ISH | Detection Chemistries DAB Detection Chemistries HOME OptiView DAB IHC Detection Kit NEW Part Number Quantity Status Components 760-700 06396500001 250 tests IVD OptiView Peroxidase Inhibitor OptiView HQ Universal Linker OptiView HRP Multimer OptiView DAB OptiView H2O2 OptiView Copper <PREV IHC ISH Description OptiView DAB IHC Detection Kit is an indirect, biotin-free system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The OptiView detection system uses a proprietary, non-endogenous hapten system to provide enhanced sensitivity and specificity. OptiView’s exclusive software gives users more control over their IHC protocol than ever before on the VENTANA BenchMark series automated slide stainers. This control allows the OptiView detection system to be optimised for any need ranging from very low-expressing antigens to shorter turnaround times. All reagents are provided pre-diluted and ready-to-use for convenient operation on VENTANA BenchMark series automated slide stainers. ultraView Universal DAB Detection Kit Part Number Quantity Status Components 760-500 05269806001 250 tests IVD ultraView Universal DAB Inhibitor ultraView Universal HRP Multimer ultraView Universal DAB Chromogen ultraView Universal DAB H202 ultraView Universal DAB Copper IHC ISH Description ultraView Universal DAB is a multimer-technology based detection system intended for the specific and sensitive detection of mouse and rabbit primary antibodies. The kit is biotin-free, thus it eliminates non-specific staining resulting from endogenous biotin. ultraView Universal DAB consists of a robust chemistry that provides a clean background for the sensitive and specific visualisation of the targeted antigen and is especially useful for the detection of antigens present in low concentrations. The primary antibody–HRP labelled antibody complex is visualised using DAB resulting in a brown/black target signal. This detection system is optimised for use on the VENTANA BenchMark series automated slide stainers. All reagents are provided pre-diluted and ready-to-use for convenient operation on VENTANA BenchMark series automated slide stainers. iVIEW DAB Detection Kit Part Number Quantity Status Components 760-091 05266157001 250 tests IVD iVIEW Inhibitor iVIEW Biotinylated lg iVIEW Streptavidin HRP iVIEW DAB iVIEW DAB H202 iVIEW Copper IHC ISH Description iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse and rabbit primary antibodies. The DAB chromogen produces a dark brown precipitate that is readily visualised by light microscopy. All reagents are provided pre-diluted and ready-to-use for convenient operation on VENTANA BenchMark series automated slide stainers. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 50 NEXT> Detection Chemistries | IHC & ISH Fast Red Detection Chemistries ultraView Universal Alkaline Phosphatase Red Detection Kit H O IHC M E ISH <PREV Part Number Quantity Status Components NEW 760-501 05269814001 250 tests IVD ultraView Red Alkaline Phosphatase ultraView Red Enhancer ultraView Red Naphthol ultraView Red Fast Red A ultraView Red Fast Red B NEXT> Description ultraView Universal Red is a multimer-technology based detection system intended for the specific and sensitive detection of mouse and rabbit primary antibodies. The kit is biotin-free, thus it eliminates non-specific staining resulting from endogenous biotin. ultraView Universal Red consists of a robust chemistry that provides a clean background for the sensitive and specific visualisation of the targeted antigen and is especially useful for the detection of antigens present in low concentrations. The primary antibody–alkaline phosphatase labelled antibody complex is visualised using Fast Red/Naphthol resulting in a bright red target signal. This detection system is optimised for use on the VENTANA BenchMark series automated slide stainers. All reagents are provided pre-diluted and ready-to-use for convenient operation on VENTANA BenchMark series automated slide stainers. ultraView Red ISH DIG Detection Kit Part Number Quantity Status Components IHC 800-505 05907128001 100 tests IVD ultraView Red ISH DIG Mouse anti-DIG Antibody ultraView Red ISH DIG Multimer ultraView Red ISH DIG pH Enhancer ultraView Red ISH DIG Naphthol ultraView Red ISH DIG Fast Red ISH Description ultraView Red ISH DIG Detection Kit is an indirect, biotin-free system for detecting DIG labelled probes. The kit is intended to identify targets by chromogenic red in situ hybridisation (ISH) in sections of formalin-fixed, paraffin-embedded tissue that are stained on VENTANA BenchMark series automated slide stainer. The clinical interpretation of any staining or the absence of staining, must be complemented by histological examination and evaluation of proper controls. Evaluation must be made by a qualified reader within the context of the patient’s clinical history and other diagnostic tests. All reagents are provided pre-diluted and ready-to-use for convenient operation on VENTANA BenchMark series automated slide stainers. ultraView Alkaline Phosphatase (AP) Red ISH Detection Kit Part Number Quantity Status Components 800-504 05278929001 100 tests IVD ultraView AP Red ISH HybReady ultraView AP Red ISH Multimer ultraView AP Red ISH pH Solution ultraView AP Red ISH Enhancer ultraView AP Red ISH Fast Red ultraView AP Red ISH Naphtol IHC ISH Description The ultraView Alkaline Phosphatase (AP) Red ISH Detection kit is an indirect, biotin-free system for detecting rabbit anti-DNP antibodies. This kit, in conjunction with a linking antibody, is used to identify DNP-labelled targets by in situ hybridisation (ISH) in sections of formalin-fixed, paraffinembedded tissue and yields a permanent red colour deposition at the site of probe-target interaction that is readily visualised by light microscopy. The ultraView AP Red ISH Detection kit is based on multimer technology and is a complement to ultraView SISH Detection to enable routine dual ISH staining. All reagents are provided pre-diluted and ready-to-use for convenient operation on VENTANA BenchMark series automated slide stainers. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 51 IHC & ISH | Detection Chemistries HOME NBT-BCIP Detection Chemistries ISH iVIEW Blue Detection Kit Part Number Quantity Status Components 800-092 05278511001 200 tests IVD iVIEW Blue Biotinylated Ig ISH iVIEW Blue Anti-Fluorescein iVIEW Blue Streptavidin Alkaline Phosphatase iVIEW Blue Enhancer iVIEW Blue NBT iVIEW Blue BCIP <PREV IHC ISH Description ISH iView Blue Detection Kit is an indirect biotin streptavidin system for detecting fluorescein-labelled probes. The kit is intended for use with formalin-fixed, paraffin-embedded tissue. ISH iView Blue Detection Kit utilises an alkaline phosphatase enzyme and NBT/BCIP substrate chromogen reaction, which yields an intense blue permanent colour deposition at the site of probe-target interaction that is readily visualised by light microscopy. All reagents are provided pre-diluted and ready-to-use for convenient operation on VENTANA BenchMark series automated slide stainers. ISH iVIEW Blue Plus Detection Kit Part Number Quantity Status Components IHC 760-097 05266181001 100 tests IVD ISH iVIEW Blue Plus HybReady ISH iVIEW Blue Plus anti-DNP ISH iVIEW Blue Plus Amp iVIEW Blue Plus Biotinylated Ig iVIEW Blue Plus Streptavidin Alkaline Phosphatase iVIEW Blue Plus Enhancer iVIEW Blue Plus NBT iVIEW Blue Plus BCIP ISH Description ISH iVIEW Blue Plus Detection Kit is an indirect biotin streptavidin system for detecting DNP-labelled probes. The kit is intended for use with formalinfixed, paraffin-embedded tissue. ISH iVIEW Blue Plus Detection Kit utilises an alkaline phosphatase enzyme and NBT/BCIP substrate chromogen reaction, which yields an intense blue permanent colour deposition at the site of probe-target interaction that is readily visualised by light microscopy. All reagents are provided pre-diluted and ready-to-use for convenient operation on VENTANA BenchMark series automated slide stainers. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 52 NEXT> Detection Chemistries | IHC & ISH HOME Silver Detection Chemistries ultraView SISH DNP Detection Kit Part Number Quantity Status Components IHC 800-098 05907136001 100 tests IVD ultraView Silver ISH DNP Rabbit anti-DNP Antibody ultraView Silver ISH DNP HRP ultraView Silver ISH DNP Chromogen A ultraView Silver ISH DNP Chromogen B ultraView Silver ISH DNP Chromogen C <PREV NEXT> ISH Description ultraView SISH DNP Detection Kit is an indirect, biotin-free system for detecting DNP-labelled probes. The kit is intended to identify targets by silver in situ hybridisation (SISH) in sections of formalin-fixed, paraffin-embedded tissue that are stained on VENTANA BenchMark series automated slide stainer instruments. The clinical interpretation of any staining or the absence of staining, must be complemented by histological examination and evaluation of proper controls. Evaluation must be made by a qualified reader within the context of the patient’s clinical history and other diagnostic tests. All reagents are provided pre-diluted and ready-to-use for convenient operation on VENTANA BenchMark series automated slide stainers. ultraView SISH Detection Kit Part Number Quantity Status Components 780-001 05271967001 100 tests IVD ultraView SISH HRP ultraView SISH HybReady ultraView Silver Chromogen A ultraView Silver Chromogen B ultraView Silver Chromogen C IHC ISH Description ultraView SISH Detection Kit is an indirect, biotin-free system for detecting rabbit primary antibodies. The kit is intended to identify targets by in situ hybridisation (ISH) in sections of formalin-fixed, paraffin-embedded tissue. This kit is to be used with INFORM HER2 DNA probe, INFORM TOP2A DNA probe, INFORM EGFR DNA probe, INFORM MET DNA probe, INFORM Chromosome 7 probe and INFORM Chromosome 17 probe. All reagents are provided pre-diluted and ready-to-use for convenient operation on VENTANA BenchMark series automated slide stainers. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 53 HOME Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 54 Intelligent Systems. Intelligent Diagnostics. Intelligent Results. <PREV NEXT> Primary Antibodies by disease state | IHC & ISH HOME <PREV NEXT> Primary Antibodies by disease state Breast Diagnostics Derm Diagnostics Gastro-Intestinal and Colorectal Diagnostics Lung Diagnostics Lymphoma Diagnostics Prostate Diagnostics www.ventana.com | www.roche.com 55 HOME Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 56 <PREV NEXT> Primary Antibodies by disease state | IHC & ISH HOME <PREV NEXT> Breast Diagnostics Discover how our breast diagnostic solutions can change your practice today. Cornerstone breast markers Emerging breast markers • • • • • • • • • • • IGF-1R (G11) • TAG-72 (B72.3) • Topoisomerase IIa (JS5B4) α-Smooth Muscle Actin (1A4) Cytokeratin 5/6 (D5/16B4) E-cadherin (36) E-cadherin (EP700Y) Estrogen Receptor (SP1) GCDFP-15 (EP1582Y) HER-2/neu (4B5) Ki-67 (30-9) p120 (98) Progesterone Receptor (1E2) Other important breast markers • • • • • • Beta-catenin (14) Calponin-1 (EP798Y) MUC1 (H23) p53 (BP-53-11) p53 (DO-7) p63 (4A4) The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 57 HOME Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 58 58 Intelligent Systems. Intelligent Diagnostics. Intelligent Results. <PREV NEXT> Primary Antibodies by disease state | IHC & ISH HOME <PREV NEXT> Derm Diagnostics We offer the most complete panel of derm tests on the market today, so you can enable precise, personalised diagnoses. Cornerstone derm markers Emerging derm markers • • • • • • • • • • • • MITF (C5/D5) • Melanoma Associated Antigen (KBA.62) • Melanoma Associated Antigen (PLN2) CD30 (Ber-H2) CD34 (QBEnd/10) CD45 (2B11&PD7/26) CD45 (RP2/18) Cytokeratin, Pan (AE1/AE3 & PCK26) Factor XIIIa (AC-1A1) Factor XIIIa (EP3372) MART-1/melan A (A103) Melanosome (HMB45) S100 (4C4.9) S100 (Polyclonal) Other important derm markers • • • • • • • CD1a (EP3622) CD4 (SP35) CD7 (SP94) CD8 (SP57) CD68 (KP-1) NGFR (MRQ-21) Tyrosinase (T311) The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 59 IHC & ISH | Primary Antibodies by disease state HOME Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 60 <PREV NEXT> Primary Antibodies by disease state | IHC & ISH HOME <PREV NEXT> Gastro-Intestinal and Colorectal Diagnostics Discover how our gastro-intestinal (GI) and colorectal cancer (CRC) diagnostic solutions can change your practice today. Cornerstone GI & CRC markers Other important GI & CRC markers • • • • • • • • • • • • • • • • • • • • • Beta-catenin (14) c-KIT (9.7) CD2 (MRQ-11) CDX-2 (EPR2764Y) CEA (CEA31) Chromogranin A (LK2H10) COX-2 (SP21) Cytokeratin 7 (SP52) Cytokeratin 20 (SP33) Epithelial Related Antigen (MOC-31) Helicobacter pylori (SP48) S100 (4C4.9) S100 (polyclonal) Synaptophysin (MRQ-40) Villin (CWWB1) CD45 (RP2/18) Kappa (Polyclonal) Lambda (Polyclonal) p53 (DO7) p63 (4A4) Smooth Muscle Actin (1A4) Emerging GI & CRC markers • MUC2 (MRQ-18) • MUC5AC (MRQ-19) • MUC6 (MRQ-20) Microsatellite instability markers • • • • MLH1 (M1) MSH2 (G219-1129) MSH6 (44) PMS2 (EPR3947) The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 61 HOME Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 62 <PREV NEXT> Primary Antibodies by disease state | IHC & ISH HOME <PREV NEXT> Lung Diagnostics Our cornerstone and emerging markers can help you to enable more informed treatment decisions. Cornerstone lung markers Emerging lung markers • • • • • • • • • • Chromogranin A (LK2H10) Cytokeratin 5/6 (D5/16B4) Cytokeratin 7 (SP52) Cytokeratin 20 (SP33) Synaptophysin (MRQ-40) Thyroid Transcription Factor-1 (8G7G3/1) c-MET (SP44) IGF-1R (G11) MUC1 (H23) Napsin A (polyclonal) Other important lung markers • • • • • • • • Calretinin (SP65) CEA (CEA31) CD99 (O13) EGFR (3C6) Ep-CAM (Ber-EP4) Epithelial Related Antigen (MOC-31) Ki-67 (30-9) WT1 (6F-H2) The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 63 HOME Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 64 <PREV NEXT> Primary Antibodies by disease state | IHC & ISH HOME <PREV NEXT> Lymphoma Diagnostics Our complete menu of cornerstone and novel tests help you enable informed treatment decisions with stain sensitivity and consistency that you—and patients—can count on. Cornerstone lymphoma markers Emerging lymphoma markers • • • • • • • • • • • • • • • • • • • • • bcl-2 (124) CD3 (2GV6) CD5 (SP19) CD10 (SP67) CD15 (MMA) CD20 (L26) CD23 (SP23) CD30 (Ber-H2) CD45 (2B11&PD7/26) CD45 (RP2/18) CD68 (KP-1) CD138 (B-A38) Cyclin D1 (SP4-R) BOB.1 (SP92) CD19 (SP119) CD22 (SP104 CD71 (MRQ-48) HGAL (MRQ-49) LMO2 (1A9-1) PD-1 (MRQ-22) T-bet (MRQ-46) Other important lymphoma markers • • • • • • • • • • • • • • ALK1 (ALK01) bcl-6 (GI191E/A8) CD1a (EP3622) CD4 (SP35) CD7 (SP94) CD8 (SP57) CD56 (MRQ-42) CD79a (SP18) Kappa (polyclonal) Lambda (polyclonal) MUM1 (MRQ-43) PAX5 (SP34) TdT (polyclonal) ZAP-70 (2F3.2) The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 65 HOME Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 66 <PREV NEXT> Primary Antibodies by disease state | IHC & ISH HOME <PREV NEXT> Prostate Diagnostics In the PSA screening era, an estimated 50% of all prostate cancer is over-treated. Our ERG IVD antibody provides additional information, so you have confidence in your diagnosis. Cornerstone prostate markers Emerging prostate markers • • • • • • • ERG (EPR3864) Basal Cell Cocktail (34betaE12 + 4A4) Cytokeratin (34betaE12) Cytokeratin 5/6 (D5/16B4) p63 (4A4) PSA (Polyclonal) PSAP (PASE/4LJ) The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 67 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV Primary Antibodies by alphabetical listing a-1-Antichymotrypsin (ACT) (polyclonal) Part Number Type Control Localisation Quantity 760-2604 05267196001 Rabbit Polyclonal Histiocytic Tumours Cytoplasmic 50 tests Benign histiocytes Description a-1-Antichymotrypsin Rabbit Polyclonal Primary Antibody reacts with histiocytes and histiocytic neoplasms. Its major application is defining the presence of a-1-Antichymotrypsin in histiocytes and tumours derived from them. In eosinophilic granuloma and malignant histiocytosis, the reaction for this marker is heterogeneous in intensity and distribution. In fibrous histiocytomas, on the other hand, a diffuse homogeneous reaction may be observed. References 1. Isaacson P, et al., Lancet. 2:964-965, 1979. 2. Palmer PE, et al., Am J Clin Pathol. 62:350-354, 1974. 3. Palmer PE, et al., Cancer. 45:1424-1431, 1980. 4. Kindblom LG, et al., Hum Pathol. 13:834-840, 1982. 5. Raintoft I, et al., Hum Pathol. 10:419-424, 1979. a-1-Antitrypsin (AAT) (polyclonal) Part Number Type Control Localisation Quantity 760-2605 05267200001 Rabbit Polyclonal Tonsil, Lymph Node, Appendix Cytoplasmic 50 tests Benign histiocytes Description a-1-Antitrypsin (AAT) Rabbit Polyclonal Primary Antibody is considered to be very useful in the study of inherited AAT deficiency, benign and malignant hepatic tumours and yolk sac carcinomas. Positive staining for a-1-Antitrypsin may also be used in detection of benign and malignant lesions of a histiocytic nature. Sensitivity and specificity of the results have made this antibody a useful tool in the screening of patients with cryptogenic cirrhosis or other forms of liver disease with portal fibrosis of uncertain etiology. References 1. Isaacson P, et al., Lancet. 2:964-965, 1979. 2. Palmer PE, et al., Am J Clin Pathol. 62:350-354, 1974. 3. Palmer PE, et al., Cancer. 45:1424-1431, 1980. 4. Kindblom LG, et al., Hum Pathol. 13:834-840, 1982. 5. Raintoft I, et al., Hum Pathol. 10:419-424, 1979. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 68 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> a-1-Fetoprotein (AFP) (polyclonal) Part Number Type Control Localisation Quantity 760-2603 05267188001 Rabbit Polyclonal Foetal Liver Cytoplasmic 50 tests Hepatocellular carcinoma Description Positive staining with AFP Rabbit Polyclonal Primary Antibody is seen in hepatocytes of foetal liver and hepatoma. Since only the traces of AFP are found in adult serum, elevated levels suggest either a benign or malignant lesion of the liver, a yolk sac carcinoma or one of a few other tumours. In conjunction with elevated serum levels, AFP has been immunohistochemically demonstrated in yolk sac carcinomas of gonadal and extragonadal sites, in hepatic malignancies and a few other neoplasms. The antigen is not denatured by most fixatives. References 1. Jacobsen GK, et al., Am J Surg Pathol. 5:257-66, 1981. 2. Peyrol S, et al., Digestion. 18:351-370, 1978. 3. Tsung SH, et al., Arch Pathol Lab Med. 101:572-574, 1977. Actin, Muscle (HUC1-1) Part Number Type Control Localisation Quantity Isotype 4. Goodman ZD, et al., Cancer. 55:124-135, 1985. 5. Roth LM, et al., Cancer. 37:812-820, 1976. 760-2502 05266882001 Mouse Monoclonal Skeletal Muscle Cytoplasmic 50 tests IgG1 Large intestine and vessel smooth muscle Description Actin, Muscle (HUC 1-1) Mouse Monoclonal Primary Antibody may be used to aid in the identification of cells of normal and abnormal myocytic lineage as an aid in diagnosis of anaplastic tumours. Actin, Muscle (HUC 1-1) antibody is directed against an epitope present on muscle isoforms of actin, but not present on the cytoplasmic isoforms. Actin, at the ultrastructural level, consists of the diffusely distributed cytoplasmic microfilaments that characterise muscle cells. Monoclonal antibodies specific to muscle actins have allowed accurate localisation to cell types. The clone HUC 1-1 shows similar immunocytochemical and biochemical characteristics to those reported for clone HHF35. In tissue sections, the HHF35 staining pattern and localisation (cardiac, skeletal as well as smooth muscle and myoepithelial cells) roughly parallels desmin reactivity. References 1. Sawtell NM, et al., Cell Motil Cytoskeleton. 11(4):318-25, 1988. 2. True LD, Atlas of Diag Immunohistopathology. 1990; JB Lippincott Company Philadelphia. 3. Tsukada T, et al., Am J Pathol. 126(1):51-60, 1987. 4. Tsukada T, et al., Am J Pathol. 127(2):389-402, 1987. 5. Elias JM, Immunohistopathology. ASCP Press, Chicago, 1990. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 69 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV Actin, Muscle Specific (HHF35) Part Number Type Control Localisation Quantity Isotype 760-2601 05267161001 Mouse Monoclonal Skeletal Muscle Cytoplasmic 50 tests IgG1/K Skeletal muscle Description Actin is a major component of the cytoskeleton. This antibody recognises actin of skeletal, cardiac and smooth muscle cells. It is not reactive with other mesenchymal cells except for myoepithelium. Actin can be resolved on the basis of its isoelectric points into three distinctive components: alpha, beta and gamma in order of increasing isoelectric point. Muscle Specific Actin recognises alpha and gamma isotypes of all muscle groups. Non-muscle cells such as vascular endothelial cells and connective tissues are non-reactive. Also neoplastic cells of non-muscle-derived tissue such as carcinomas, melanomas and lymphomas are negative. This antibody is useful in the identification of rhabdoid cellular elements. References 1. Gown AM, et al., Am J Pathol. 125:191, 1986. 2. Schmidt R, et al., Am J Pathol. 131:199, 1988. 3. Azumi N, et al., Modern Pathology. 1:469-474, 1988. Actin, Smooth Muscle (1A4) Part Number Type Control Localisation Quantity Isotype 760-2833 05268303001 Mouse Monoclonal Appendix, Uterus Cytoplasmic 50 tests IgG Colonic and blood Description Actin is a major component of the cytoskeleton and is present in every cell type. Actin can be resolved on the basis of its isoelectric points into three distinctive components: alpha, beta and gamma in order of increasing isoelectric point. Smooth Muscle Actin antibody does not stain cardiac or skeletal muscle, but, it will stain myofibroblasts and myoepithelial cells. This antibody could be used together with Muscle Specific Actin to distinguish leiomyosarcoma from rhabdomyosarcoma. In most cases of rhabdomyosarcoma, this antibody gives negative results, whereas Muscle Specific Actin is positive in the rhabdomyoblasts. Leiomyosarcomas are positive with both Muscle Specific Actin and Smooth Muscle Actin antibodies. References 1. Cooke PH, J Cell Biol. 68:539-556, 1976. 2. Skalli O, et al., J Cell Biol. 103:2787-2796, 1986. 3. Gown AM, et al., J Cell Biol. 100:807-813, 1985. 4. Kuroda M, Biochem Biophys Acta. 843:20-213, 1985. 5. Lazarides E, J Histochem Cytochem. 223:507-528, 1975. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 70 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> Adrenocorticotropin (ACTH) (polyclonal) Part Number Type Control Localisation Quantity 760-2708 05268176001 Rabbit Polyclonal Normal Pituitary Cytoplasmic 50 tests Pituitary Description ACTH is a useful marker in classification of pituitary tumours. It reacts with ACTH-producing cells (corticotrophs). It also may react with other tumours (e.g. some small cell carcinomas of the lung) causing paraneoplastic syndromes by secreting ACTH. References 1. Pizarro CB, et al., Braz J Med Biol Res. 37(2):235-43, 2004 2. Viacava P, et al., J Endocrinol Invest. 26(1):23-8, 2003. 3. Kageyama K, et al., Am J Med Sci. 324(6):326-30, 2002. ALK1, CONFIRM (ALK01) Part Number Type Control Localisation Quantity Isotype 4. Fan X, et al., J Histochem Cytochem. 50(11):1509-16, 2002 5. Japon MA, et al., J Clin Endocrinol Metab. 87(4):1879-84, 2002. 800-2918 05278783001 Mouse Monoclonal Anaplastic Large Cell Lymphoma Cytoplasmic, Nuclear 50 tests IgG3/K Anaplastic large cell lymphoma Description CONFIRM ALK1 (ALK01) Mouse Monoclonal Primary Antibody recognises a formalin resistant epitope in both the p80 protein, identified as a hybrid of the anaplastic lymphoma kinase (ALK) protein, and the nucleophosmin (NPM) and the 200 kD normal ALK proteins. ALK1 (ALK01) antibody may also recognise any ALK protein chimeric produced as a result of variant translocations involving the ALK gene on chromosome 2. ALK1 (ALK01) antibody recognises varying degrees of ALK expression in both the cytoplasm and nucleus of anaplastic lymphoma cells. ALK protein expression is substantially specific for anaplastic lymphomas, except for weak expression in some normal cells in the central nervous system including neurons, glial cells and endothelial cells. ALK expression may also be seen in inflammatory myofibroblastic tumours and rare rhabdomyosarcomas. References 1. Pulford K, et al., Blood. 89(4):1394-404, 1997. 2. Griffin CA, et al., Cancer Res. 59(12):2776-80, 1999. 3. Falini B, et al., Am J Pathol. 153(3):875-86, 1998. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 71 IHC & ISH | Primary Antibodies by alphabetical listing HOME Annexin A1 (MRQ-3) Part Number Type Control Localisation Quantity Isotype <PREV 760-4435 05973945001 Mouse Monoclonal Hairy Cell Leukaemia Cytoplasmic, Membranous 50 tests IgG1 Spleen, hairy cell leukaemia Description Annexin (ANXA1) is strongly expressed on the cell membrane and occasionally in the cytoplasm of tumour cells in 97% of samples from patients with hairy cell leukaemia. By contrast, B-cell lymphomas other than hairy cell leukaemia, including typical splenic lymphoma with villous lymphocytes and patients with variant hairy cell leukaemia—as defined by current morphologic, phenotypic and clinical criteria—are ANXA1-negative. In a study by Falini, et al. ANXA1 immunodetection was 100% sensitive and specific for hairy cell leukaemia. Normal B cells from different lympho-hemopoietic tissues were ANXA1-negative. In this study the expression of ANXA1 in myeloid cells, macrophages or T-cell subset served as positive control. These findings validated the results of gene expression profiling in hairy cell leukaemia at the protein level by showing that ANXA1 is consistently expressed in this type of leukaemic disease, but not in other B-cell lymphomas. Negativity for ANXA1 was also present in patients with splenic lymphoma with villous lymphocytes, variant hairy cell leukaemia, prolymphocytic leukaemia, marginal zone and lymphoplasmacytoid lymphomas. Thus, ANXA1 is a molecule specific to hairy cell leukaemia that can be used to differentiate this disease from other B-cell lymphomas. Wang, et al. showed that high ANXA1 expression is frequent in oesophageal and oesophagogastric junction adenocarcinomas, is associated with more advanced pathologic T stage and the presence of distant metastasis and is an independent prognostic factor for patient survival. References 1. Falini B, et al., Lancet. 363(9424):1869-70, 2004. Erratum in: Lancet. 363(9427):2194, 2004. 2. Wang KL, et al., Clin Cancer Res. 12(15):4598-604, 2006. 3. Xia SH, et al., Oncogene. 21(43):6641-8, 2002. 4. Dreier R, et al., Histochem Cell Biol. 110(2):137-48, 1998. Basal Cell Cocktail NEW (34βE12+4A4) Part Number Type Control Localisation Quantity Isotype 790-4536 06364497001 (50 tests); 790-1010 06419445001 (250 tests) Mouse Monoclonal Normal Basal Cells in Prostate Tissue 4A4 = Nucleus, 34βe12 = Cytoplasm 50 Tests (790-4536), 250 Tests (790-1010) IgG2a/K Prostate carcinoma Description VENTANA Basal Cell Cocktail (34βE12+p63) Mouse Monoclonal Primary Antibody is an antibody cocktail of p63 (4A4) and keratin (34βE12). p63 (4A4) antibody reacts with the p63 molecule in the nuclei of human prostatic basal cells and urothelial tissues. Keratin (34βE12) antibody reacts with cytokeratins 1, 5, 10 and 14 and stains the cytoplasm of human prostatic basal cells. This antibody cocktail may be used to aid in the differentiation of benign and malignant prostatic lesions. References 1. Shah RB, et al., Am J Clin Pathol. 122:517-523, 2004. 2. Zhou M, et al., Am J Surg Pathol. 27:365–371, 2003. 3. Shah RB, et al., Am J Surg Pathol. 26:1161–1168, 2002 4. Yang A, et al., Mol Cell. 2:305-316, 1998. 5. Dairkee SH, et al., J Natl Cancer Inst. 80:691-695, 1988. 6. Gown AM, et al., Amer J Clin Pathol. 84:413-424, 1985. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 72 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME BCA-225 (Cu-18) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-2607 05267226001 Mouse Monoclonal Breast Carcinoma Cytoplasmic 50 tests IgG1 in situ and invasive breast carcinoma Description BCA-225 (Cu-18) Mouse Monoclonal Primary Antibody recognises a human breast carcinoma associated glycoprotein BCA-225 (220-225 kD). This protein differs in size and distribution from other breast carcinoma antigens. Unlike other antibodies against breast carcinoma antigens, this antibody does not react with benign or malignant colonic, stomach, prostate, liver, pancreas, thyroid or parotid tissues. Adenocarcinomas of the lung, ovary and endometrium also stain with this antibody. References 1. Ceriani RL, et al., Monoclonal Ab’s and Breast Cancer Boston, Martinus, Nijhoff, 1985. 2. Mesa-Tejada R, et al., Am J Pathol. 130:305-314, 1988. bcl-2, CONFIRM (124) Part Number Type Control Localisation Quantity Isotype 3. Loy TS, et al., Am J Clin Pathol. 96(3):326-9, 1991. 4. Ma CK, et al., Am J Clin Pathol. 99(5):551-7, 1993. 790-4464 05986826001 Mouse Monoclonal B Cells of the Mantle Zone, Interfollicular T Cells in Tonsil. Cytoplasmic 50 tests IgG1 Lymphoma Description CONFIRM bcl-2 (124) Mouse Monoclonal Primary Antibody is directed against human bcl-2 expressed by B cells of the mantle zone and interfollicular T cells. This antibody exhibits a cytoplasmic staining pattern and may be used to aid in the identification of follicular lymphomas and diffuse large cell lymphomas, and to differentiate follicular lymphomas from reactive lymph nodes. References 1. Chao DT, et al., Annu Rev Immunol. 16:395-419, 1998. 2. Pezzella F, et al., N Engl J Med. 329:690-4, 1993. 3. Campos L, et al., Blood. 81:3091-6, 1993. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 73 IHC & ISH | Primary Antibodies by alphabetical listing HOME bcl-6 (GI191E/A8) Part Number Type Control Localisation Quantity Isotype <PREV 760-4241 05269008001 Mouse Monoclonal Tonsil, Lymph Node Nuclear 50 tests IgG1 Tonsil Description bcl-6 is a transcriptional regulator gene which codes for a 706-amino acid nuclear zinc finger protein. Antibodies to this protein stain the germinal centre cells in lymphoid follicles, the follicular and interfollicular cells in follicular lymphoma, diffuse large B-cell lymphomas and Burkitt’s lymphoma, as well as the majority of the Reed-Sternberg cells in nodular lymphocyte predominant in Hodgkin’s disease. In contrast, bcl-6 (GI191E/A8) Mouse Monoclonal Primary Antibody rarely stains mantle cell lymphoma and MALT lymphoma. bcl-6 expression is seen in approximately 45% of CD30+ anaplastic large cell lymphomas but is consistently absent in other peripheral T-cell lymphomas. References 1. Dogan A, et al., Am J Surg Pathol. 24(6):846-852, 2000. 2. Shaffer AL, et al., Immunity. 13:199-212, 2000. Beta-Catenin (14) Part Number Type Control Localisation Quantity Isotype 3. Kraus Md, et al., Am J Surg Pathol. 24(8):1068-78, 2000. 4. Carbone A, et al., Blood. 90(6):2445-2450, 1997. 760-4242 05269016001 Mouse Monoclonal Fibromatosis of Breast or Abdomen Nuclear 50 tests IgG1 Breast carcinoma Description Beta-catenin is a 92 kD protein normally found in the cytoplasm of the cell in the submembranous location. This protein is associated with E-Cadherin and may be essential for the function of E-Cadherin. Mutations in the Beta-catenin gene result in nuclear accumulation of this protein. Nuclear accumulation of this protein has been demonstrated in fibromatosis lesions of the breast and abdomen and therefore is useful in differentiating this lesion from other spindle cell lesions that may occur in these locations. Nuclear accumulation of Beta-catenin has also been demonstrated in colorectal carcinoma. References 1. Alman BA, et al., Am J Pathol. 151(2):329-34, 1997. 2. Li C, et al., Am J Pathol. 153(3):709-14, 1998. 3. Kuhnen C, et al., Pathol Rex Pract. 196(5):299-304, 2000. 4. Abraham SC, et al., Hum Pathol. 33(1):39-46, 2002. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 74 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME BG8, Lewisy (F3) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-4450 05973767001 Mouse Monoclonal Lung Adenocarcinoma Cytoplasmic 50 tests IgG1 Adenocarcinoma of colon Description Blood group antigens have been examined as potential discriminators between pulmonary adenocarcinoma (PACA) and epithelioid mesotheloma (EM). Lewisy is the only one of these that appears to have some merit. BG8 is raised from the SK-LU-3 lung cancer line and its ability to distinguish between PACA and EM was first reported by Jordon and colleagues in 1989. Three groups have since reported their results. These studies included 231 cases of PACA and 197 cases of EM. Sensitivity and specificity for PACA were both 93%. Yaziji H, et al. reported a sensitivity of non-mesothelial antigens for adenocarcinoma as organ dependent, with BG8 performing at 98% in the breast cancer group and 100% in the lung cancer group. The specificity of the non-mesothelial (non-EM) antigens for adenocarcinoma was 98% for BG8. They concluded using logical regression analysis that a three-antibody immunohistochemical panel including calretinin, BG8 and MOC-31 would provide 96% sensitivity and specificity for distinguishing EM from adenocarcinoma from a variety of sources (lung, ovary, breast, stomach). References 1. Davidson B, et al., Virchows Arch. 435(1):43-9, 1999. 2. Jordan D, et al., Am J Pathol. 135(5):931-7, 1989. 3. King JE, et al., Histopathology. 48(3):223-32, 2006. Review. 4. Marchevsky AM, et al., Appl Immunohistochem Mol Morphol. 15(2):140-4, 2007. 5. Ordonez NG, et al., Am J Surg Pathol. 27(8):1031-51, 2003. BOB.1 NEW (SP92) Part Number Type Control Localisation Quantity 6. Ordonez NG, et al., Am J Surg Pathol. 24(4): 598-606, 2000. 7. Pan CC, et al., Appl Immunohistochem Mol Morphol. 13(4):34752, 2005. 8. Yaziji H, et al., MMod Pathol. 19(4):514-23, 2006. 760-4593 06433308001 Rabbit Monoclonal Tonsil Nuclear; Cytoplasmic 50 tests Follicular lymphoma Description BOB.1 (SP92) is used as an aid in the identification of B-cells in germinal centres and mantle cells and differentiation of lymphomas within the context of an antibody panel, the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist. References 1. Steimle-Grauer SA, et al. Virchows Arch. 442:284-293, 2003. 2. Valsami S, Pappa V, et al. Haematologica. 92(10):1343-50, 2007. 3. Stein H, et al. Blood. 97:496-501, 2001. 4. Hertel CB, et al. Oncogene. 21:4908-4920, 2002. 5. Pileri SA, et al. Am J Pathology. 162:243- 253, 2003. 6. Hoefnagel JJ, et al. Moder Pathology. 19 :1270-1276, 2006. 7. Greiner A, et al. Am J Pathol. 156:501-507, 2000. 8. Kuroda H, et al. Breast Cancer. 14(3):317-22, 2007. 9. Saez A-I, et al. Mod Pathol. 15(3):21-220, 2002. 10. Loddenkemper C, et al. J Pathol. 202:60-69, 2004. 11. Hoeller S, et al. Histopathology. 56, 217- 228, 2010. 12. Browne P, et al. Am J Clin Pathol 120:767-777, 2003. 13. Gibson SE, et al. Am J Clin Pathol. 126:916-924, 2006. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 75 IHC & ISH | Primary Antibodies by alphabetical listing c-KIT (CD117), PATHWAY FDA approved (9.7) Part Number Type Control Localisation Quantity Isotype 790-2951 05278317001 Rabbit Monoclonal GIST, Skin, Breast Cytoplasmic, Membranous 50 tests IgG Membranous — GIST Description: PATHWAY c-KIT (9.7) Rabbit Monoclonal Primary Antibody is intended for the qualitative detection of KIT protein in gastro-intestinal stromal tumours (GISTs). It is indicated as an aid in the selection of GIST within the context of the patient’s clinical history, tumour morphology and other diagnostic tests evaluated by a qualified pathologist. It may be used after the diagnosis of GIST as an aid in the selection of GIST patients who may qualify for imatinib mesylate (Gleevec/Glivec) therapy. PATHWAY c-KIT (9.7) antibody is optimised for use on the VENTANA BenchMark series automated slide stainers and for manual application in combination with iVIEW DAB Detection Kit and accessories. The clinical interpretation of any staining or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests. The Role of KIT Gene Mutations in the Development of GISTs: In their landmark 1998 publication, Dr. Hirota and his colleagues established not only that GISTs express KIT, but that KIT gene mutations are present in these tumours. Furthermore, they showed that the resulting mutant KIT isoforms demonstrate kinase activity in the absence of stem cell factor, the natural ligand for KIT. These observations have been confirmed by a growing number of groups and it is now established that KIT mutations are present in >85% of GISTs. The majority of mutations occurs in exon 11 (65-70% of GISTs) and includes a wide range of deletions, insertions, point mutations or combinations thereof. An insertion/reduplication of six base pairs in exon 9 is found in ~15% of GISTs, almost exclusively in those arising in the small intestine. Mutations also occur in exons 13 and 17, but are much rarer. Regardless of the exon involved, KIT gene mutations in GISTs are invariably in-frame and, when cloned and expressed in vitro, have constitutive kinase activation. Moreover, phosphorylation of KIT is consistently detectable in GIST tumour extracts, supporting a direct role for KIT in intracellular signaling. Clinical Significance: GISTs arise predominantly in the stomach (60%) and small intestine (25%), but also occur in the rectum (5%), oesophagus (5%) and a variety of other locations (5%), including appendix, gall bladder, mesentery and omentum. Affected patients range in age from the teens to the 90’s, but the majority are older and the peak is around age 60. A slight male predilection has been observed in most studies. There are no solid figures on the true incidence of GISTs, but it is estimated that ~4,500 new cases are diagnosed each year in the United States. In 1998, Drs. Seichi Hirota (Osaka University) and Lars-Gunnar Kindblom (University of Gothenburg) each independently observed that GISTs express the receptor tyrosine kinase KIT (CD117). Their observations provided a clue to the possible cell of origin for GISTs, namely the interstitial cells of Cajal (ICC). These inconspicuous, dendritic-like cells are widely distributed throughout the muscularis propria of the oesophagus, stomach, small and large bowel. They play an important role in gut motility by regulating slow-wave contractions. Like GISTs, ICC express KIT and the majority are also positive for CD34. The hypothesis that GISTs are pathogenetically related to ICC in the gut wall, as proposed by both Dr. Hirota and Dr. Kindblom, is now widely accepted. Subsequent studies from a large number of different laboratories have confirmed that KIT is the single most specific marker of GISTs. Immunodetectable KIT is present on the cell surface and/or cytoplasm of GIST tumour cells in approximately 90% of cases. Highly Sensitive and Specific: The scientifically advanced rabbit monoclonal antibody technology of PATHWAY c-KIT clone 9.7 is the source of optimised assay sensitivity and specificity. Directed against the c-terminal domain of the c-KIT protein, PATHWAY c-KIT recognises both wild-type and mutant forms of the c-KIT protein. PATHWAY c-KIT (9.7) specifically binds to antigen located in the cell membrane and cytoplasmic regions of mast cells, interstitial cells of Cajal (ICC) and GIST cells. The advanced performance of the PATHWAY c-KIT rabbit monoclonal antibody and standardised slide preparation assist the pathologist with the clear differentiation of positives and negatives in this qualitative assay. The following are examples of staining for c-KIT in GIST and physiologic tissues (intestine) using PATHWAY c-KIT. References 1. Blechman J, et al., J. Biol. Chem. 228:(6)4399-4406, 1993 2. Corless C, et al., Am. J. of Pathol. 160:1567-1572, 2002. 3. Fletcher C, et al., Human Pathol. 33:459-465, 2002. 4. Heinrich MC, et al., J. Clin. Oncol. 20:1692-703, 2002. 5. Heinrich M, et al., Proceedings of ASCO. 21:2a(abstract #6), 2002. 6. Hirota S, et al., Int. J .Clin. Oncol. 6:1-5, 2001. 7. Hirota S, et al., Science. 279:577-80, 1998. 8. Hirota S, et al., Am. J. Surg. Pathol. 24:326-7, 2000. 9. Isozaki K, et al., Am. J. of Pathol. 157:1581-5, 2000. 10. Kindblom LG, et al., Am. J. Pathol. 152:1259-69, 1998. 11. Maeyama H, et al., Gastroenterology. 120:210-5, 2001. 12. Miettinen M, et al., Virchows Arch. 438:1-12, 2001. 13. Nishida T, et al., Nat. Genet. 19:323-4, 1998. 14. Rubin BP, et al., Int. J. Surg. Pathol. 8:5-10, 2000. 15. Rubin BP, et al., Cancer Res. 61:8118-8121, 2001. 16. Taniguchi M, et al., Cancer Res. 59:4297-300, 1999. 17. Yarden Y, et al., EMBO Journal. 6:3341-3351, 1987. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 76 Primary Antibodies by alphabetical listing | IHC & ISH c-MET (Total), CONFIRM (SP44) Part Number Type Control Localisation Quantity 790-4430 05571219001 Rabbit Monoclonal Kidney, Gastric Carcinoma, Non-Small Cell Lung Carcinoma Cytoplasmic, Membranous 50 tests Colon carcinoma Description CONFIRM Total c-MET (SP44) Rabbit Monoclonal Primary Antibody is directed against a membranous and/or cytoplasmic epitope present in human normal epithelial or tumour cells. This antibody may be used to aid in the identification of normal and neoplastic c-MET expressing cells. References 1. Prat M, et al., Int J Cancer. 49(3):323-328, 1991. 2. Comoglio PM, et al., Nature Reviews Drug Disc. 7(6):504-516, 2008. C3d NEW (polyclonal) Part Number Type Control Localisation Quantity Isotype 3. Lutterbach B, et al., Cancer Research. 67(5):2081-2088, 2007. 4. Engelman JA, et al., Science. 316(5827):1039-1043, 2007. 760-4522 06419143001 Rabbit Polyclonal Acute Rejected Kidney Transplant Membranous, Cytoplasmic 50 tests IgG Description Complement component C3 plays a central role in the activation of complement system. Its activation is required for both classical and alternative complement activation pathways. C3d deposition in the renal transplant PTCs (peritubular capillaries) is indicative of AR (acute rejection) with subsequent high probability of graft loss. C3d antibody, combined with C4d antibody, can be utilised as a tool for diagnosis of AR and warrant prompt and aggressive anti-rejection treatment. References 1. Bickerstaff A, et. al., Am J Pathol, 173:347-357, 2008. 2. Kuypers DR, et. al., Transplantation, 76:102-108, 2003. 3. Eggertsen G, et. al, APMIS, 109:825-834, 2001. 4. Pfaltz K, et. al., J Cutan Pathol. 37:654-658, 2010. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 77 IHC & ISH | Primary Antibodies by alphabetical listing HOME C4d (polyclonal) Part Number Type Control Localisation Quantity Isotype <PREV 760-4436 05973937001 Rabbit Polyclonal Lymph Node, Tonsil, Kidney (Reject Transplant) Membranous, Cytoplasmic 50 tests IgG Kidney, acute rejection Description C4d is a stable split product remnant of classical complement activation which becomes covalently bound to endothelium and basement membrane after induction of the classical antibody-induced pathway. As an established marker of antibody-mediated acute renal allograft rejection and its proclivity for endothelium, this component can be detected in peritubular capillaries in both chronic renal allograft rejection as well as hyperacute rejection, acute vascular rejection, acute cellular rejection and borderline rejection. It has been shown to be a significant predictor of transplant kidney graft survival and is therefore an aid in treating acute rejection. References 1. Jianghua C, et al., Clin Transplant. 19(6):785-91, 2005. 2. Kayler LK, et al., Transplantation. 85(6):813-20, 2008. 3. Ranjan P, et al., Nephrol Dial Transplant. 23(5):1735-41, 2008. 4. Nadasdy GM, et al., Hum Pathol. 36(11):1178-85, 2005. CA 19-9 (121SLE) Part Number Type Control Localisation Quantity Isotype 5. Seemayer CA, et al., Nephrol Dial Transplant. 22(2):568-76, 2007. 6. Bouron-Dal Soglio D, et al., Hum Pathol. 39(7):1103-10, 2008. 760-2609 05267242001 Mouse Monoclonal Colon, Salivary Gland Cytoplasmic 50 tests IgM Malignant gastro-intestinal carcinoma Description CA 19-9 antigen is highly expressed in gastro-intestinal (gastric, pancreatic and colonic) adenocarcinomas and salivary gland mucoepidermoid carcinomas. CA 19-9 (121SLE) Mouse Monoclonal Primary Antibody is usually not reactive with breast, kidney and prostate carcinomas. References 1. Gatalica Z, et al., Applied IHC. 2(3):205-211, 1994. 2. Encabo G, et al., Bulletin Cancer (Paris). 73:256-9, 1986. 3. Basso D, et al., Med Sci Res. 17:13-4, 1989. 4. Tabuchi Y, et al., Cancer. 66:1529-33, 1990. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 78 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME CA 125 (OC125) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-2610 05267269001 Mouse Monoclonal Ovarian Carcinoma Cytoplasmic, Membranous 50 tests IgG1/K Serous adenocarcinoma of ovary Description CA-125 reacts with malignant ovarian epithelial cells. The antigen is formalin resistant permitting the detection of ovarian cancer by immunohistochemistry, although serum assays for this protein are widely used to monitor ovarian cancer. CA-125 also reacts with antigens in seminal vesicle carcinoma and anaplastic lymphoma. References 1. Dabawat S, et al., Int J Gyn Path. 2:275-285, 1983. 2. Davis H, et al., Cancer Res. 46:6143-6148, 1986. 3. Nouwen E, et al., Cancer Res. 46:866-876, 1986. Calcitonin (polyclonal) Part Number Type Control Localisation Quantity 4. Quirk J, et al., J Obst Gyn. 159:644-649, 1988. 5. Fukazawa I, et al., Gynecol Obstet. 243:41-50, 1988. 760-2611 05267277001 Rabbit Polyclonal Medullary Carcinoma of Thyroid Cytoplasmic 50 tests Medullary carcinoma of thyroid Description Immunohistochemical staining with Calcitonin Rabbit Polyclonal Primary Antibody has proven to be an effective way of demonstrating calcitonin-producing cells in the thyroid. C-cell hyperplasia and medullary thyroid carcinomas stain positive for calcitonin. Studies of calcitonin have resulted in the identification of a wide spectrum of C-cell proliferative abnormalities. References 1. Copp DH, et al., Endocrinology. 70:638-649, 1962. 2. Kameda Y, et al., Cell Tissue Res. 206:403-415, 1980. 3. Coombes RC, et al., Lancet. 1:1080-1083, 1974. 4. Dayal Y, et al., Cancer. 43:1331-1338, 1979. 5. DeLellis RA, et al., Am J Clin Pathol. 7(4):587-294, 1978. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 79 IHC & ISH | Primary Antibodies by alphabetical listing HOME Caldesmon (E89) Part Number Type Control Localisation Quantity Isotype <PREV 760-4375 05463459001 Rabbit Monoclonal Smooth Muscle from Bowel, Oesophagus, Uterus Cytoplasmic 50 tests IgG Breast, sclerosing adenosis Description Caldesmon is a regulatory protein found in smooth muscle and other tissues which interacts with actin, myosin, tropomyosin and calmodulin. Caldesmon (E89) Rabbit Monoclonal Primary Antibody labels smooth muscle and tumours of smooth muscle, myofibroblastic and myoepithelial differentiation. Caldesmon antibody has also been used to differentiate epithelioid mesothelioma from serous papillary carcinoma of the ovary. References 1. Comin CE, et al., Am J Surg Pathol. 31(8): 1139-48, 2007. 2. Watanabe K, et al., Hum Pathol. 30(4): 392-6, 1999. 3. McCluggage WC, Adv Anat Pathol. 11(3): 162-71, 2004. Calponin-1 (EP798Y) Part Number Type Control Localisation Quantity Isotype 4. Miettinen M, et al., Arch Pathol Lab Med. 130(10): 1466-78, 2006. 5. Comin CE, et al., Am J Surg Pathol. 30(4): 463-9, 2006. 760-4376 05435684001 Rabbit Monoclonal Smooth Muscle from Bowel, Oesophagus, Uterus Cytoplasmic 50 tests IgG Breast, sclerosing adenosis Description Calponin is a 34 kD polypeptide that interacts with actin, tropomyosin and calmodulin. It is involved in smooth muscle contraction mechanism and is restricted exclusively to smooth muscle tissue. Calponin-1 (EP798Y) Rabbit Monoclonal Primary Antibody has been found to be useful in differentiating benign sclerosing lesions of the breast from carcinoma. Calponin positivity has also been noted in malignant myoepithelioma and pleomorphic adenoma of salivary gland origin, as well as angiomatoid malignant fibrous histiocytoma. References 1. Wang NP, et al., Appl Immunohistochem. 5(3):141-151, 1997. 2. Nagao T, et al., Cancer. 83(7):1292-9m, 1998. 3. Savara AT, et al., Mod Pathol. 10(11):1093-1100, 1997. 4. Fanburg-Smith JC, et al., Hum Pathol. 30(11):1336-43, 1999. 5. Hornick JL, et al., Am J Surg Pathol. 27(9): 1183-96, 2003. 6. Werling RW, et al., Am J Surg Pathol. 27(1): 82-90, 2003. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 80 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME Calretinin, CONFIRM (SP65) Part Number Type Control Localisation Quantity <PREV NEXT> 790-4467 05992184001 Rabbit Monoclonal Mesothelioma, Normal Appendix Cytoplasmic, Nuclear 50 tests Pleura, malignant mesotheliona Description CONFIRM Calretinin (SP65) Rabbit Monoclonal Primary Antibody is directed against the calcium binding protein calretinin, that is expressed by normal and reactive mesothelium, eccrine glands of skin, Sertoli cells of the testis, ovarian stromal cells and adrenal cortical cells. This antibody exhibits a nuclear and cytoplasmic staining pattern and may be used to aid in the identification of mesothelioma and in distinguishing mesothelioma from adenocarcinoma. References 1. Kuznicki J, et al., Biochem J. 308(Pt 2):607–612, 1995. 2. Andressen C, et al., Cell Tissue Res. 271:181–208, 1993. 3. Rogers JH, J Cell Biol. 105(3):1343-53, 1987. 4. Lugli A, et al., Hum Pathol. 34(10):994-1000, 2003. 5. Cao QJ, et al., Int J Gynecol Pathol. 20:346-52, 2001. 6. Oates J, et al., Histopathology. 36(4):341-7, 2000. 7. Doglioni C, et al., Am J Surg Pathol. 20:1037-46, 1996. 8. Nagel H, et al., Pathol Res Pract. 194:759-64, 1998. 9. Ordonez NG, Mod Pathol. 11:929-33, 1998. 10. Leers MP, et al., Histopathology. 32:209-16, 1998. 11. McCluggage WG, et al., Histopathology. 38(5):403-8,2001. 12. Nogales FF, et al., Int J Gynecol Pathol. 21(1):34-40, 2002. 13. Cappello F, et al., Pathology. 33(2):142-8, 2001. 14. Attanoos RL, et al., Histopathology. 37(3):224-31, 2000. 15. Gotzos V, et al., Am J Surg Pathol. 23:701-11, 1999. Carcinoembryonic Antigen (CEA) NEW (CEA31) Part Number Type Control Localisation Quantity Isotype 760-4594 06433316001 Mouse Monoclonal Adenocarcinoma of Colon, Colon Mucosa Cytoplasmic 50 tests IgG1 Colorectal carcinoma Description CEA (CEA31) Mouse Monoclonal Primary Antibody used as an aid in the identification and diagnosis of adenocarcinomas within the context of an antibody panel, the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist. References 1. Go, VLW et al. Cancer. 37:562-566, 1976. 2. Delellis, RA et al. Am J Clin Pathol 50:587-594, 1978. 3. Kamino, H et al. Cancer. 61:1142-1148, 1988. 4. Tron, V et al. Arch Pathol Lab Med. 111:291-293, 1987. 5. Abutaily, AS et al. J Clin Pathol. 55(9):662-8, 2002. 6. Bhatnagar, J et al. Anticancer Res. 22(3):1849-57, 2002. 7. Carella, R et al. Am J Surg Pathol. 25(1):43-50, 2001. 8. Lagandijk, JH et al. J Clin Pathol. 52(4):283-90, 1999. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 81 IHC & ISH | Primary Antibodies by alphabetical listing HOME CD1a NEW (EP3622) Part Number Type Control Localisation Quantity Isotype <PREV 760-4525 06419160001 Rabbit Monoclonal Thymus Membranous 50 tests IgG1 Description CD1a, a protein of 43 to 49 kD, has been shown to be expressed on dendritic cells and cortical thymocytes. Langerhans cells in the skin and some epithelia also express this protein. This antigen is expressed on cells comprising Langerhans cell histiocytosis and Langerhans cell sarcoma. CD1a (EP3622) Rabbit Monoclonal Primary Antibody has been used to differentiate various cutaneous lymphomas (T-cell) from B-cell lymphomas and pseudolymphomas. References 1. Angel CE, et al., Blood. 113:1257-67, 2009. 2. Emile JF, et. al., Am J Surg Pathol. 19:636-641, 1995. 3. Stefano AP, et. al., Br J Haematol. 105:394-41, 1999. 4. Han X, et. al., Am J Clin Pathol, 127:578-544, 2007. CD2 (MRQ-11) Part Number Type Control Localisation Quantity Isotype 5. Pomplun S, et. al., Histopathol, 40:152-158, 2002. 6. Alexiev BA, et. al., Diagnostic Pathology, 2:13, 2007. 7. Adachi Y, et. al., Pathol Intl., 58 :169-173, 2008. 760-4377 05463467001 Mouse Monoclonal Tonsil, Lymph Node Cytoplasmic, Membranous 50 tests IgG1/K Tonsil Description CD2 is one of the earliest T cell lineage restricted antigens to appear during T cell differentiation and only a rare CD2+ cell can be found in the bone marrow. It is found in all T-lymphocytes and natural killer cells but not in B cells or any other cell population. CD2 can be considered a pan-T cell antigen and is therefore useful for the identification of virtually all normal T-lymphocytes. It is also very useful in the assessment of lymphoid malignancies as it is expressed in the majority of precursor and post-thymic lymphomas and leukaemias, and is not expressed by B neoplasms (Foon & Todd, 1986). As with other pan-T cell antigens, CD2 may be aberrantly deleted in some neoplastic T cell population, especially peripheral T cell lymphomas. Rarely slg+ B cell neoplasms have been described to form spontaneous E-rosettes but these reactions are not mediated via the CD2 receptor (Knowles, 1989). References 1. Aguilera NS, et al., Arch Pathol Lab Med. 130(12):1772-9, 2006. 2. Barrionuevo C, et al., Appl Immunohistochem Mol Morphol. 15(1):38-44, 2007. 3. Bovenschen HJ, et al., Br J Dermatol. 153(1):72-8, 2005. 4. Foon KA, et al., Blood. 68:1-31, 1986. 5. Gonzalez L, et al., Journal of Comparative Pathology. 125:41-7, 2001. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 82 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME CD3, CONFIRM (2GV6) Part Number Type Control Localisation Quantity <PREV NEXT> 790-4341 05278422001 Rabbit Monoclonal Tonsil, Spleen Cytoplasmic, Membranous 50 tests Tonsil Description CONFIRM CD3 (2GV6) Rabbit Monoclonal Primary Antibody (IgG) is directed against the non-glycosylated epsilon chain of the human CD3 molecule. CD3 is expressed in the membrane and cytoplasm of normal and neoplastic T cells. The CD3 antigen is first detectable in early thymocytes and its appearance probably represents one of the earliest signs of commitment to the T cell lineage. This antibody detects both normal and neoplastic T cells. References 1. Chetty R, et al., J Pathol. 173(4): 303-307, 1994. 2. Clark EA, et al., Immunology Today. 10(7): 225-28, 1989. 3. Clevers H, et al., Eur J Immunol. 18(5): 705-710, 1988. 4. Clevers H, et al., Ann Rev of Immunology. 6: 629-662, 1988. 5. Campana D, et al., J Immunol. 138(2): 648-655, 1987. CD4, CONFIRM (SP35) Part Number Type Control Localisation Quantity 6. Dennings SM, et al., Oxford University Press, Oxford-New YorkTokyo, 1987: 144-147. 7. Beverley, PC, et al., Eur J Immunol. 11(4): 329-334, 1981. 8. Meuer SC, et al., Nature. 303(5920): 808-810, 1983. 9. Mason DY, et al., J Clin Pathol. 42:1194-1200, 1989. 790-4423 05552737001 Rabbit Monoclonal Tonsil, Liver Membranous 50 tests Lymphoma Description CONFIRM CD4 (SP35) Rabbit Monoclonal Primary Antibody is intended for the qualitative detection of CD4 in sections of normal and neoplastic human tissues. CD4 is present on helper-inducer T-lymphocytes that recognise antigen in the context of MHC class 2 molecules. CD4 positive staining results may aid in identifying T-cell lymphomas and in identifying the T-helper-inducer cell subset of T-lymphocytes in normal tissues. References 1. Reinherz EL, et al. Proc. Natl. Acad. Sci. USA. 76(8):4061-5, 1979. 2. Brady RL, et al. Curr. Topics Microbiol. Immunol. 205:1-18, 1996. 3. Doyle C, et al. Nature. 330(6145):256-9, 1987. 4. Dalgleish AG, et al., Nature. 312(5996):763-7, 1984. 5. Garcia-Herrera A, et al., J Clin Oncol. 26(20):3364-71, 2008. 6. Maddon PJ, et al., Cell. 42(1):93-104, 1985. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 83 IHC & ISH | Primary Antibodies by alphabetical listing HOME CD5, CONFIRM (SP19) Part Number Type Control Localisation Quantity <PREV 790-4451 05929903001 Rabbit Monoclonal Tonsil, Lymphoma Cytoplasmic, Cell Membrane 50 tests Lymphoma Description CONFIRM CD5 (SP19) Rabbit Monoclonal Primary Antibody is directed against human CD5 expressed on the plasma membrane of virtually all human T cells and the B1a subset of human B cells found in the follicular mantle zones, bone marrow and peripheral blood. Staining CD5 is commonly used as part of several IHC panels to determine T cell and B cell sub-classifications. CD5 antibody may be used to aid in the identification of T cell lymphomas and certain B cell lymphomas, including mantle cell lymphoma. References 1. Dalloul A, Autoimmun. 8:349-353, 2009. 2. Dono M, et al., Int J Biochem Cell Biol. 36:2105-2111, 2004. 3. De Leon ED, et al., Mod Pathol. 11:1046-1051, 1998. CD7 NEW (SP94) Part Number Type Control Localisation Quantity Isotype 4. Cabezudo E, et al., Hematologica. 84:413-418, 1999. 5. Matolcsy A, et al., Am J Pathol. 147:207-216, 1995. 6. Suguro M, et al., Cancer Sci. 97:868-874, 2006. 790-4558 06537847001 Rabbit Monoclonal Tonsil, Thymus Membranous 50 tests Rabbit Ig T-cell lymphoma Description CD7 (SP94) Rabbit Monoclonal Primary Antibody is directed against the 40kD transmembrane glycoprotein CD7, which is present in thymocytes and mature T cells. CD7 (SP94) antibody may be used to aid in the identification of T cell lymphomas. References 1. Sempowski GD, et al. Crit Rev Immunol. 19:331-348, 1999. 2. Cotta AC, et al. Appl Immunohistochem Molec Morphol. 14: 291-295, 2006. 3. Al Saati T, et al. Appl Immunohistochem Molec Morphol. 9: 289-296, 2001. 4. Ormsby A, et al. J Am Acad Dermatol. 45:405–413, 2001. 5. Inaba T, et al. Leuk Lymphoma. 42:1161-1171, 2001. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 84 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME CD8, CONFIRM (SP57) Part Number Type Control Localisation Quantity <PREV NEXT> 790-4460 05937248001 Rabbit Monoclonal Tonsil, T cell lymphoma Cell Membrane 50 tests T-cell lymphoma Description CONFIRM CD8 (SP57) Rabbit Monoclonal Primary Antibody is intended for the qualitative detection of CD8 in sections of normal and neoplastic human tissues. The CD8 glycoprotein is present on cytotoxic/suppressor T-lymphocytes that recognise antigen in the context of MHC class 1 molecules. CD8 positive staining results may aid in identifying T cell lymphomas and in identifying the T cytotoxic/suppressor cell subset of T-lymphocytes in normal tissues. References 1. Reinherz EL, et al., Immunol Today. 4:5-8, 1983. 2. Reinherz EL, et al., Nature. 294:168-170, 1981. CD10 NEW (SP67) Part Number Type Control Localisation Quantity Isotype 3. Perussia B, et al., J Immunol. 131:223-231, 1983. 4. Bierer BE, et al., Ann Rev Immunol. 7:579-599, 1989. 790-4506 05857856001 Rabbit Monoclonal Tonsil Membranous, Cytoplasmic 50 tests Rabbit Ig Lymphoma Description CD10 (SP67) Rabbit Monoclonal Primary Antibody is directed against the CD10 molecule or common acute lymphoblastic leukaemia antigen (CALLA), expressed on the surface of early lymphoid cells and on various non-lymphoid tissues including breast myoepithelial cells, bile canaliculi, fibroblasts, kidney tubular brush borders and small intestine epithelium. This antibody exhibits a cell membranous and/or cytoplasmic staining pattern and may be used to aid in the identification of Burkitt’s lymphoma and follicular germ cell lymphoma, and in the classification of some carcinomas such as renal cell carcinoma. References 1. Gregory CD, et al. Apoptosis. 4:11-20, 1999. 2. Shipp MA, et al. Proc Natl Acad Sci USA. 85:4819-4823, 1988. 3. Kaufmann O, et al. Am J Clin Pathol. 111:117-122, 1999. 4. Shipp MA, et al. Proc Natl Acad Sci USA. 86:297-301, 1989. 5. Arber DA, et al. Appl Immunohistochem. 5:125-140, 1997. 6. Chu P, et al. Appl Immunohistochem & Molec Morphol. 8:257262, 2000. 7. Avery A, et al. Am J Surg Pathol. 24:203-210, 2000. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 85 IHC & ISH | Primary Antibodies by alphabetical listing HOME CD14 NEW (EPR3653) Part Number Type Control Localisation Quantity Isotype <PREV 760-4523 06419151001 Rabbit Monoclonal Tonsil Membranous, Cytoplasmic 50 tests IgG Description CD14 is a surface protein preferentially expressed on monocytes/macrophages. It binds lipopolysaccharide binding protein and recently has been shown to bind apoptotic cells. CD14 antibody labels Kupffer cells in liver sinusoids. In lymphoid tissues, dendritic cells are distinctly stained. Most other normal tissues are negative. This antibody labels monocyte-macrophages and Langerhans cells in Langerhans cell histiocytosis. Tumour cells are positive for CD14 in monocytic leukaemia and true histiocytic lymphomas. Sinusoidal histiocytes express CD14 and CD169, whereas most of the other monocyte-derived cells in reactive lymph node lack these markers. CD14 antibody labels numerous diffuse large B-cell lymphomas and splenic marginal zone lymphoma, but not other B-cell lymphomas. References 1. Gregory CD, et. al., Apoptosis. 4:11-20, 1999. 2. Larregina AT, et. al., Nature Immunol. 2:1151-1158, 2001. 3. Ziegler-Heitbrock HW, et. al., Immunol Today. 14:121-125, 1993. 4. Steiniger B, et. al., Immunology. 92:307-316, 1997. 5. Buckley PJ, et. al., Am J Pathol 128:505-520, 1987. CD15, CONFIRM (MMA) Part Number Type Control Localisation Quantity Isotype 6. Hartnell A, et. al., Blood. 97:288-296, 2001. 7. Marmey B, et. al., Hum Pathol. 37:68-77, 2006. 8. Hsiao CH, et. al., J Formos Med Assoc. 105:701-707, 2006. 9. Qubaja M, et. al., Vichows Arch. 454:411-419, 2009. 760-2504 05266904001 Mouse Monoclonal Hodgkin’s Lymphoma Cytoplasmic, Membranous 50 tests IgM Hodgkin’s lymphoma, Reed-Sternberg cells Description Antibodies against CD15 normally react in a strong cell surface membrane staining pattern with granulocytes and granulocyte precursors, monocytes, a subset of tissue macrophages and activated T-lymphocytes. CONFIRM CD15 (MMA) Mouse Monoclonal Primary Antibody also reacts against the Reed-Sternberg cells of Hodgkin’s disease and, because it recognises a carbohydrate antigen, is also expressed by a variety of carcinoma types, but is negative in malignant mesotheliomas. Antibodies against CD15 are used diagnostically to (1) support a diagnosis of acute myeloid leukaemia, (2) help support a diagnosis of Hodgkin’s disease and (3) help separate poorly differentiated adenocarcinomas from malignant mesothelioma. References 1. Pinkus GS, et al., Am J Pathol. 119:244-252, 1985. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 86 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME CD19 NEW (SP110) Part Number Type Control Localisation Quantity <PREV NEXT> 790-4587 06434681001 Rabbit Monoclonal Tonsil, Lymph Node Membranous 50 tests B-cell acute lymphocytic leukaemia Description CD19 (SP110) Rabbit Monoclonal Primary Antibody is directed against the CD19 protein. This antibody may be used to detect the CD19 standard and variant proteins in the vast majority of B cell lymphomas including follicular lymphoma, diffuse large B-cell lymphoma and Burkitt’s lymphoma. References 1. Mehra R, et al. Mod Path, 20:538-544, 2007. 2. Tedder T, et al. Immunol Today. 15:437-442, 1994. 3. Scheuermann R, et al. Leuk Lym. 18:385-3977, 1995. 4. Ginaldi L, et al. J Clin Pathol. 51:364-369, 1998. CD20, CONFIRM (L26) Part Number Type Control Localisation Quantity Isotype 5. Masir N, et al. Histopath. 2006;48:239-246. 6. Kraj M, et al. Leuk Res. 35:169-176, 2011. 7. Hultin LE, et al. Cytometry. 14:196–204, 1993. 8. Foss H, et al. Blood. 94:3108-31013, 1999. 760-2531 05267099001 Mouse Monoclonal Tonsil, Lymph Node Membranous 50 tests IgG2a/K Tonsil Description CONFIRM CD20 (L26) Mouse Monoclonal Primary Antibody specifically binds to antigens located in the plasma membrane and cytoplasmic regions of normal B lymphocytes and may also be expressed in Reed-Sternberg cells. This phosphoprotein is found on the surface of normal and malignant B cells and is thought to act as a receptor during B cell activation and differentiation. Plasma cells are negative for CD20. CD20 (L26) antibody can be used to detect B cells from peripheral blood, lymph node, spleen, tonsil and bone marrow. It is also used in the classification of a majority of B cell malignancies, including many acute leukaemias and chronic lymphocytic leukaemias. References 1. Coles FB, et al., Mod Pathol. 1(4): 274-278, 1988. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 87 IHC & ISH | Primary Antibodies by alphabetical listing HOME D21 C (2G9) Part Number Type Control Localisation Quantity Isotype <PREV 760-4245 05269059001 Mouse Monoclonal Tonsil, Lymph Node Membranous 50 tests IgG2a Tonsil, germinal centre Description CD21 antigen is an integral membrane glycoprotein of molecular weight 145 kD. CD21 (2G9) Mouse Monoclonal Primary Antibody is useful in the identification of follicular dendriditic cell matrix found in normal lymph nodes and tonsillar tissue. This antibody also labels follicular dendritic cell tumour/sarcomas. The antigen is absent on T-lymphocytes, monocytes and granulocytes. References 1. Dillon KM, et al., J Clin Pathol. 55(10):791-4, 2002. 2. Pileri SA, et al., Histopathology. 41:1-29, 2002. 3. Kunihiko M, et al., J Histochem Cytochem. 50:1475-1485, 2002. 4. Herrmann LM, et al., Am J Pathol. 162:1075-1081, 2003. CD21 (EP3093) Part Number Type Control Localisation Quantity Isotype 5. Biddle DA, et al., Modern Pathology. 15:50-58, 2002. 6. Cheuk W, et al., Am J Surg Pathol. 25(6):721-31, 2001. 7. Chang KC, et al., J Pathol. 201(3):404-12, 2003. 8. Chan AC, et al., Histopathol. 38(6):510-8, 2001. 760-4438 05973902001 Rabbit Monoclonal Lymph Node, Tonsil Cytoplasmic, Membranous 50 tests IgG1 Tonsillar hypertrophy Description CD21 antigen is an integral membrane glycoprotein of molecular weight 140 kD. CD21 (EP3093) Rabbit Monoclonal Primary Antibody is useful in the identification of follicular dendritic cell matrix found in normal lymph nodes and tonsillar tissue. This antibody also labels follicular dendritic cell tumour/sarcomas. The antigen is absent on T-lymphocytes, monocytes and granulocytes. References 1. Dillon KM, et al. J Clin Pathol. 55(10):791-4, 2002. 2. Pileri SA, et al. Histopathology. 41(1):1-29, 2002. 3. Maeda K, et al. J Histochem Cytochem. 50(11):1475-1485, 2002. 4. Herrmann LM, et al. Am J Pathol. 162(4):1075-1081, 2003. 5. Biddle DA, et al. Modern Pathology. 15(1):50-58, 2002. Erratum in: Mod Pathol. 15(4):475, 2002. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 88 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME CD22 NEW (SP104) Part Number Type Control Localisation Quantity <PREV NEXT> 790-4588 06391117001 Rabbit Monoclonal Tonsil, Lymphoma Membranous, Cytoplasmic 50 tests Tonsil Description CD22 (SP104) Rabbit Monoclonal Primary Antibody is directed against the type 1 integral membrane glycoprotein CD22. CD22 (SP104) antibody exhibits a cell membranous and/or cytoplasmic staining pattern, and may be used to aid in the identification of B-cell lymphomas. References 1. Townsend MJ, et al. Immunol Rev. 237:264-283, 2010. 2. Poe JC, et al. Nature Immunol. 5:1078- 1087, 2004. 3. Tedder TF, et al. Annu Rev Immunol. 15:481-504, 1997. CD23, CONFIRM (SP23) Part Number Type Control Localisation Quantity Isotype 4. Polson Ag, et al. Leukaemia. 24:1566-1573, 2010. 5. Boue DR, et al. Blood. 71:1480-1486, 1988. 790-4408 05479258001 Rabbit Monoclonal Tonsil Cytoplasmic 50 tests IgG1 Normal tonsil Description Expression of CD23 has been detected in neoplastic cells from cases of B-cell chronic lymphocytic leukaemias and B-cell small lymphocytic lymphomas. Some hairy cell leukaemias and diffuse large B-cell lymphomas are likewise positive. CD23 is generally absent on mantle cell lymphomas. Accordingly, CD23 staining may be used in the classification of small lymphocytic lymphomas (usually positive) and mantle cell lymphomas (usually negative). References 1. Kaiserlian D, et. al., Immunology. 80:90-95, 1993. 2. Aubry JP, et al., The CD23 antigen is the human lymphocyte receptor for IgE. In:McMichael AJ, Beverley PCL, Cobbold S, Crumpton MJ, Gilks W, Gotch FM, et al. Leukocyte Typing III, White Cell Differentiation Antigens. Oxford University Press, Oxford, 1987: 417-419. 3. Kikutani H, et al., CD23 is a low affinity Fcε receptor (FcεR): regulation of FcεR expression. In: McMichael AJ, Beverley PCL, Cobbold S, Crumpton MJ, Gilks W, Gotch FM, et al. Leukocyte Typing III, White Cell Differentiation Antigens. Oxford University Press, Oxford, 1987: 419-422. 4. Pallesen G. The distribution of CD23 in normal human tissues and in malignant lymphomas. In: McMichael AJ, Beverley PCL, Cobbold S, Crumpton MJ, Gilks W, Gotch FM, et al. Leukocyte Typing III, White Cell Differentiation Antigens. Oxford University Press, Oxford, 1987: 383-386. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 89 IHC & ISH | Primary Antibodies by alphabetical listing HOME CD25 (4C9) Part Number Type Control Localisation Quantity Isotype <PREV 760-4439 05973899001 Mouse Monoclonal Lesions of Mastocytosis, Small Bowel Cytoplasmic, Membranous 50 tests IgG2b Spleen, hairy cell leukaemia Description According to the World Health Organisation classification system, the major diagnostic criterion for bone marrow involvement by systemic mastocytosis (SM) is the presence of dense aggregates (>15 cells) of mast cells. Expression of CD25, a low-affinity receptor for interleukin-2 (IL-2), is a reliable diagnostic tool for distinguishing neoplastic mast cell aggregates from reactive proliferations and has therefore recently become a minor criterion for the diagnosis of SM. Hahn, et al. demonstrated that aberrant staining of mast cell clusters by CD25 antibody in GI (gastro-intestinal) biopsies was essentially diagnostic of SM. CD25 antibody has also been useful in identifying mast cells in skin biopsies in the setting of urticaria pigmentosa, which is predictive of SM. Quantitation of regulatory T cells (Treg) in the setting of hepatocellular carcinoma (HCC) has been used as an independent predictive factor of tumour recurrence after hepatic resection for HCC. Also, the percentage of tumour infiltrating CD25 + FOXP3 + regulatory T cells among tumour cells, inside tumour parenchyma and at its periphery, is significantly higher in recurrent cutaneous melanoma than in non-recurrent melanoma. References 1. Hahn HP, et al., Am J Surg Pathol. 31(11):1669-76, 2007. 2. Hollmann TJ, et al., Am J Surg Pathol. 32(1):139-45, 2008. 3. Miracco C, et al., Oncol Rep. 18(5):1115-22, 2007. CD30, CONFIRM (Ber-H2) Part Number Type Control Localisation Quantity Isotype 4. Siddiqui SA, et al., Clin Cancer Res. 13(7):2075-81, 2007. 5. Yang XH, et al., J Hepatol. 45(2):254-62, 2006. 790-2926 05278201001 Mouse Monoclonal Hodgkin’s Lymphoma Membranous 50 tests IgG1/K Hodgkin’s lymphoma, Reed-Sternberg cells Description CD30 antigen is expressed in mononuclear Hodgkin’s cells and multinucleated Reed Sternberg cells of Hodgkin’s lymphoma, as well as on anaplastic large cell lymphomas. This antibody variably produces membranous, cytoplasmic and Golgi staining of both lymphoma cells and scattered large activated B and T cells in lymph nodes, spleen, tonsil and thymus. This antibody may also stain a small proportion of plasma cells. References 1. Froese P, et al., J Immunology. 139(6): 2081-2087, 1987. 2. Stein H, et al., Blood. 66: 848-858, 1985. 3. Stein H, et al., Int J Cancer. 30(4): 445-459, 1982. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 90 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME CD31 (1A10) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-4246 05269067001 Mouse Monoclonal Appendix, Placenta, Tonsil Cytoplasmic, Membranous 50 tests IgG1/K Tonsil Description CD31 is expressed by stem cells of the hematopoietic system and is primarily used to identify and concentrate these cells for experimental studies as well as for bone marrow transplantation. Endothelial cells also express this marker, therefore, antibodies to CD31 have been used as a tool to identify the vascular origin of neoplasms. CD31 has shown to be highly specific and sensitive for vascular endothelial cells. Staining of non-vascular tumours (excluding hematopoietic neoplasms) has not been observed. References 1. Parums DV, et al., J. Clin. Path. 1990; 43:752-757. 2. De Young BR, et al., Ap. Immuno. 1993; 1:97-100. 3. Alles JU, et al., J. Histo. Cyto. 1986; 34:209-214. CD31 (JC-70) Part Number Type Control Localisation Quantity Isotype 4. Santeusanio G, et al., Appl. Immunohistochem Mol. Morphol. 2003 Dec; 11(4):359-63. 5. Alexander-Sefre F et al., J. Clin. Pathol. 2003 Oct; 56(10):786-8. 6. Allison KH et al., Am. J. Surg. Pathol. 2004 Mar; 28(3):298-307. 760-4378 05463475001 Mouse Monoclonal Appendix, Placenta, Tonsil Cytoplasmic, Membranous 50 tests IgG1/K Tonsil Description CD31 is expressed by stem cells of the hematopoietic system and is primarily used to identify and concentrate these cells for experimental studies as well as for bone marrow transplantation. Endothelial cells also express this marker, therefore, antibodies to CD31 have been used as a tool to identify the vascular origin of neoplasms. CD31 has shown to be highly specific and sensitive for vascular endothelial cells. Staining of non-vascular tumours (excluding hematopoietic neoplasms) has not been observed. References 1. Parums DV, et al., J Clin Pathol. 43(9):752-7, 1990. 3. Alles JU, et al., J Histochem Cytochem. 34(2):209-14, 1986. 2. De Young BR, et al., Applied Immunohistochemistry. 1: 97-100, 1993. 4. Alexander-Sefre F, et al., J Clin Pathol. 56(10):786-8, 2003. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 91 IHC & ISH | Primary Antibodies by alphabetical listing HOME CD34 (QBEnd/10) Part Number Type Control Localisation Quantity Isotype <PREV 760-2620 05267323001 Mouse Monoclonal Appendix, Placenta, Tonsil Membranous 50 tests IgG1 Breast carcinoma Description CD34 (QBEnd/10) Mouse Monoclonal Primary Antibody recognises a cell surface antigen of approximately 110 kD that is expressed selectively on human hematopoietic progenitor cells, including myeloid and lymphoid lineage progenitors, and a significant portion of acute leukaemia. In addition to this stem cell recognition, this marker is expressed by vascular endothelium. Additionally, it appears that proliferating endothelial cells express this molecule in greater amounts than non-proliferating endothelial cells. References 1. Civin CL, et al., London Academic Press. 818-825, 1989. 2. Fina L, et al., Blood. 75:2417-2426, 1990. 3. Sankey EA, et al., J Pathol. 43:752-757, 1990. 4. Ramani P, et al., Histopathology, 17:237-242, 1990. CD43 (L60) Part Number Type Control Localisation Quantity Isotype 5. Aziza J, et al., Am J Clin Pathol. 96:25-31, 1990. 6. Torlakovic G, et al., Arch Pathol Lab Med. 126(7):823-8, 2002. 7. Salizzoni M, et al., Transplantation. 15;76(5):844-8, 2003. 8. Fanburg-Smith JC, et al., Mod Pathol. 16(3):263-71, 2003. 760-2511 05266980001 Mouse Monoclonal Tonsil, Lymph Node Membranous 50 tests IgG1 Tonsil, cytoplasmic membrane staining of T-lymphocytes Description CD43 (also known as leucosialin or sialophorin) is a glycoprotein antigen expressed on the membrane and in the cytoplasm of T cells, cells of myeloid origin and some B cells. CD43 (L60) Mouse Monoclonal Primary Antibody binds specifically to antigens located in the plasma membrane and cytoplasmic regions of normal granulocytes, monocytes, histiocytes, T cells and some B cells. Tumours expressing this antigen include most T-cell lymphomas and some B-cell lymphomas. References 1. Strickler JG, et al., Hum Pathol. 18(8):808-14, 1987. 2. Stross WP, et al., J Clin Pathol. 42(9):953-61, 1989. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 92 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME CD44 NEW (SP37) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 790-4537 06364985001 Rabbit Monoclonal Tonsil Membranous 50 tests IgG Description CD44 (SP37) Rabbit Monoclonal Primary Antibody is directed against the CD44 protein. CD44 is a type I transmembrane receptor protein expressed in several cell types including T and B lymphocytes, monocytes, granulocytes, erythrocytes, fibroblasts, epithelial and mast cells. This antibody exhibits a membranous staining pattern and may be used to detect the CD44 standard and variant proteins in a variety of neoplastic tissues, including squamous cell and urothelial carcinoma. References 1. Aruffo A, et al., Cell. 61:1303-13,1990. 2. Hascall V, et al., Cold Spring Harbor Laboratory Press. 2008. 3. Endo K, et al., J. of Hepatology. 32:78-84, 2000. 4. Southgate J, et al., Int. J. Cancer. 62:449-456, 1995. 5. Bartolazzi A, et al., JCB. 132(6):1199-1208, 1996. CD45 (LCA), CONFIRM (RP2/18) Part Number Type Control Localisation Quantity Isotype 760-2505 05266912001 Mouse Monoclonal Tonsil Membranous 50 tests IgG1/K Lymphoma Description CD45, LCA (leucocyte common antigen) is expressed on the cytoplasmic membrane of T and B lymphocytes, monocytes, macrophages, mast cells and weakly on granulocytes. CONFIRM CD45, LCA (RP2/18) Mouse Monoclonal Primary Antibody is directed against the CD45RB epitope found on the membrane of leucocytic cells. This antibody has been shown to react with the 220-, 205- and 190 kD isoforms of CD45. References 1. Zapata JM, et al., J Immunol. 152(8): 3852-3861, 1994. 2. Pulido R, et al., J Immunol. 140(11): 3851-3857, 1988. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 93 IHC & ISH | Primary Antibodies by alphabetical listing HOME CD45 (LCA) (2B11 & PD7/26) Part Number Type Control Localisation Quantity Isotype <PREV 760-4279 05269423001 Mouse Monoclonal Tonsil, Lymph Node Membranous 50 tests IgG1/K Tonsil Description Leucocyte Common Antigen (LCA) Mouse Monoclonal Primary Antibody is routinely used to aid in the differential diagnosis of undifferentiated neoplasms, whenever malignant lymphoma is suspected by the morphological or clinical data. It is a highly specific antibody therefore a positive result is highly indicative of lymphoid or myeloid origin. Certain types of lymphoid neoplasms may lack CD45 (Hodgkin’s disease, some T-cell lymphomas and some leukaemias) so its absence does not rule out a hematolymphoid tumour. This antibody is expressed almost exclusively by cells of hematopoietic lineage and is present in most benign and malignant lymphocytes, erythrocytes and plasma cell precursors. References 1. Mason DY, et al., Am J Pathol. 128:1-4, 1987. 2. Hall PA, et al., Histopathology. 13:149-160, 1988. 3. Kurtin PJ, et al., Hum Path. 16:353-365, 1985. 4. Maluf HM, et al., Mod Pathol. 8(2): 155-9, 1995. CD45R (MB1) Part Number Type Control Localisation Quantity Isotype 5. Caballero T, et al., J Clin Pathol. 48(8): 743-8, 1995. 6. Vasef MA, et al., Am J Clin Pathol. 108(1): 54-9, 1997. 7. Saxena A, et al., Am J Clin Pathol. 112(4): 495-512, 1999. 8. Kraus MD, et al., Am J Surg Pathol. (8): 1068-78, 2000. 760-2624 05267340001 Mouse Monoclonal Tonsil, Lymph Node Membranous 50 tests IgG1 Large B-cell lymphoma Description CD45R antibody stains preferentially B cells and their neoplasms, but is less specific as it will also react with some T-cell lymphomas and non-lymphoid tumours. The antigen for this antibody is in the membrane of all B cells with the exception of plasma cells and some mature T cells. References 1. Hall PA, et al., J Clinical Pathology. 40:870-873, 1987. 2. Myskow MW, et al., Am J Pathology. 90:564-574, 1988. 3. West KP, et al., J Pathology. 150:89-101, 1986. 4. Poppema S, et al., Am J Pathology. 127:418-429, 1987. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 94 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME CD45RO, CONFIRM (UCHL-1) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 790-2930 05278244001 Mouse Monoclonal Tonsil, Lymph Node Membranous 50 tests IgG2a Lymph node, normal Description CONFIRM CD45RO (UCHL-1) Mouse Monoclonal Primary Antibody reacts predominantly with the p180 component of the Leucocyte Common Antigen (LCA) antigen family and weakly with the 190 kD and 205 kD isoforms. This reagent reacts with most T-lymphocytes, macrophages and Langerhan’s cells of normal tissue. References 1. Berti E, et al., Am J Clin Pathol. 95(2):188-193, 1991. CD56 NEW (MRQ-42) Part Number Type Control Localisation Quantity 760-4596 06433359001 Rabbit Monoclonal Pancreatic Islet Cells, Pancreatic Endocrine Cells, Neuroblastoma Cytoplasmic, Membranous 50 tests Pancreatic neuroendocrine carcinoma Description CD56 (MRQ-42) Rabbit Monoclonal Primary Antibody is used as an aid in the identification of neural/neurodendocrine tissues, natural killer (NK) cells, NK-like T-cells and diagnosis of related neoplasms within the context of an antibody panel, the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist. References 1. Gerardy-Schahn, R et al. Int J Canc Suppl 8:38- 42, 1994. 2. Michalides, R et al. Int J Canc Suppl 8:34-37, 1994. 3. Kibbelaar, RE et al. Euro J of Cancer. 27(4):431-435, 1991. 4. Langdon, SP et al. Cancer Research. 48(21):6161-6165, 1988. 5. Sumi, M et al. Leuk Lymphoma. 44(1): 201-4, 2003. 6. Trejo, O et al. J Cutan Pathol. 29(7): 397-406, 2002. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 95 IHC & ISH | Primary Antibodies by alphabetical listing HOME CD57 (NK-1) Part Number Type Control Localisation Quantity Isotype <PREV 760-2626 05267366001 Mouse Monoclonal Tonsil, Lymph Node Membranous 50 tests IgM/K Tonsil Description CD57 (NK-1) Mouse Monoclonal Primary Antibody marks a subset of lymphocytes known as natural killer (NK) cells. Follicular centre cell lymphomas often contain many NK cells within the neoplastic follicles. NK-1 also stains neuroendocrine cells and their derived tumours, including carcinoid tumour and medulloblastoma. NK-1 reportedly also reacts with a variety of cell types in non-lymphoid tissues. References 1. Lanier LL, et al., Journ Immun. 131(4):1789-1796, 1983. 2. Ritchie AW, et al., Clin and Exp Imm. 51(3):439-447, 1983. 3. Caillaud JM, et al., Cancer Res. 44(10):4432-4439, 1984. CD61 (2f2) Part Number Type Control Localisation Quantity Isotype 4. Tucker GC, et al., Cell Differentiation. 14(3):223-230, 1984. 5. Abo T, et al., Cellular Immun. 73(2):376-384, 1982. 760-4249 05269091001 Mouse Monoclonal Bone Marrow Cytoplasmic 50 tests IgG1 Bone marrow Description CD61 (2f2) Mouse Monocloanl Primary Antibody labels the IIIa subunit of the non-covalently linked glycoprotein heterodimer IIb/IIIa complex present on human platelets and their precursors. This antibody is useful in identifying megakaryoblastic differentiation as seen in megakaryoblastic leukaemia. References 1. Thiele J, et al., Eur J Haematol. 44:63-70, 1990. 2. Thiele J, et al., Virchows Archiv B Cell Pathol. 58:295-302, 1990. 3. Goldman BI, et al., Modern Pathology. 14:589-594, 2001. 4. Fox SB, et al., Histopathology. 17(1):69-74, 1990. 5. Duperray A, et al., Blood. 74(5):1603-11, 1989. 6. Campana D, et al., Leukaemia. 4(9):620-4, 1990. 7. Thiele J, et al., Anal Quant Histol. 12(4):285-9, 1990. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 96 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME CD63 (NKI/C3) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-4379 05463483001 Mouse Monoclonal Malignant Melanoma Cytoplasmic, Membranous 50 tests IgG1/K Malignant melanoma in tonsil Description This antibody reacts with a 53 kDa protein which forms a part of the family of tetraspan moieties. The antigen was originally designated as a lysosomal membrane protein characterised as an activation dependent platelet surface antigen. In fact the CD63 antigen has a diverse distribution on the surface and in the cytoplasm of many cell types including lymphoid, myeloid, endothelial cells and melanoma. It has been quite useful in identifying malignant melanoma. Mete, et al. found it useful in differentiating renal oncocytomas (RO) from eosinophilic renal cell carcinomas (eRCC). In his series of 35 ROs, 94% demonstrated apical and/or polar CD63 positivity. Of his 77 eRCCs, 96% showed diffuse cytoplasmic staining. References 1. Azorsa DO, et al., Blood. 15:78(2):280-4, 1991. 2. Barrio MM, et al., Hybridoma. 17(4):355-64, 1998. 3. Demetrick DJ, et al., J Natl Cancer Inst. 84(6):422-9, 1992. CD68, CONFIRM (KP-1) Part Number Type Control Localisation Quantity Isotype 4. Mete O, et al., Virchows Arch. 447(6):938-46, 2005. Epub 2005 Aug 17. 5. Kwon MS, et al., Lung Cancer. 57(1):46-53, 2007. Epub 2007 Mar 12. 790-2931 05278252001 Mouse Monoclonal Tonsil, Lymph Node Cytoplasmic, Membranous 50 tests IgG1/K Tonsil, histiocytes Description CONFIRM CD68 (KP-1) Mouse Monoclonal Primary Antibody reacts with a 110 kD intracellular glycoprotein associated with the cell membrane of macrophages and some myeloid elements. References 4. Pulford KAF, et al., J Clin Pathol. 42:414-21, 1989. 1. Facchetti F, et al., Histopathology. 19:141-5, 1991. 5. Vergier B, et al., Blood. 959(7):2212-8, 2000. 2. Ruco LP, et al., Am J Clin Pathol. 92:273-9, 1989. 3. Cordell JL, et al., Oxford Univ. Press-Oxford, New York 1995; 925-927. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 97 IHC & ISH | Primary Antibodies by alphabetical listing HOME CD71 NEW (MRQ-48) Part Number Type Control Localisation Quantity Isotype <PREV 760-4589 06433162001 Mouse Monoclonal Bone Marrow Cytoplasmic, Membranous 50 tests IgG1 Description CD71 (MRQ-48) Mouse Monoclonal Primary Antibody is indicated as an aid in the identification of the erythroid precursors in bone marrow and in the determination of acute myeloid leukaemia and myelodysplastic syndrome (MDS). CD79a, CONFIRM (SP18) Part Number Type Control Localisation Quantity 790-4432 05640296001 Rabbit Monoclonal B Cell Lymphoma, Tonsil Cytoplasmic, Membranous 50 tests Non-Hodgkin’s lymphoma Description CONFIRM CD79a (SP18) Rabbit Monoclonal Primary Antibody is intended for the detection of CD79a in normal and neoplastic human tissues. CD79a antibody is directed against a protein expressed on the surface of B lymphocytes at all stages of maturation, from B lymphocyte precursors through plasma cells. Expression of CD79a may aid in the identification of B cell lineage in malignant lymphomas. References 1. Berg JM, et al., Biochemistry, 5th Ed. WH Freeman and Company, NY, 2002. 2. Chu PG, et al., Appl Immunohistochem Mol Morphol. 9(2): 97-106, 2001. 3. Bhargava P, et al., Am J Clin Pathol. 128(2):306-313, 2007. 4. Blakolmer K, et al., Mod Pathol. 13(7):766-772, 2000. 5. Mason DY, et al. Blood. 86(4):1453-9, 1995. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 98 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME CD99, CONFIRM (O13) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 790-4452 05913594001 Mouse Monoclonal Pancreatic Islet Cells, Sertoli Cells of the Testis Membranous 50 tests IgG1 Ewing’s sarcoma Description CONFIRM CD99 (O13) Mouse Monoclonal Primary Antibody is directed against human CD99 expressed on T-lymphocytes, cortical thymocytes, granulosa cells of the ovary, pancreatic islet cells, CNS ependymal cells and Sertoli’s cells. CD99 shows a plasma membrane location. This antibody may be used as part of a panel to aid in the identification of Ewing’s sarcoma and related peripheral neuroectodermal tumours. References 1. Ambros IM, et al., Cancer. 67:1886-1893, 1991. 2. Scotlandia K, et al., Cancer Research. 60(18):5134-5142, 2000. 3. Milanezi F, et al., Histopathology. 39:578–583, 2001. CD138/syndecan-1 (B-A38) Part Number Type Control Localisation Quantity Isotype 4. Pelosi G, et al., Virchows Arch. 437:270–274, 2000. 5. Gordon MD, et al., Mod Pathol. 11:769–773, 1998. 6. Ozdemirli M, et al., Mod Pathol. 14:1175–1182, 2001. 760-4248 05269083001 Mouse Monoclonal Tonsil, Plasmacytoma Membranous 50 tests IgG Tonsil, plasma cells Description CD138/syndecan-1 (B-A38) Mouse Monoclonal Primary Antibody is a useful marker for labelling normal and neoplastic plasma cells and plasmacytoid lymphomas. Various forms of Hodgkin’s disease have also shown positive staining with this antibody. References 1. Chilosi M, et al., Mod Pathol. 12(12):1101-6, 1999. 2. Sebestzen A, et al., Br J Haematol. 104(2):412-9, 1999. 3. Carbone A, et al., Blood. 91(3):747-55, 1998. 4. Bayer-Garner IB, et al., Mod Pathol. 14(10):1052-8, 2001 5. Lampert IA, et al., Appl Immunohistochem Mol Morphol. 13(2):12431, 2005. 6. Oksanen A, et al., J Clin Pathol. 58(4):376-81, 2005. 7. O’Connell FP, et al., Am J Clin Pathol. 121(2):254-63, 2004. 8. Coloma L, et al., Am J Surg Pathol. 28(6):736-47, 2004. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 99 IHC & ISH | Primary Antibodies by alphabetical listing HOME CD163 (MRQ-26) Part Number Type Control Localisation Quantity Isotype <PREV 760-4437 05973929001 Mouse Monoclonal Inflamed Tissue Cytoplasmic, Membranous 50 tests IgG1 Placenta, normal Description CD163 (MRQ-26) Mouse Monoclonal Primary Antibody was recently identified as an acute phase-regulated transmembrane protein whose function is to mediate the endocytosis of haptoglobinhemoglobin complexes. This receptor is expressed on the surface of monocytes (low expression) and tissue macrophages, [also known as histiocytes] (high expression). It is a member of the cysteine-rich scavenger receptor superfamily, encoded by a gene localised on human chromosome 12p13.3. Soluble in plasma, CD163 functions as an anti-inflammatory signal and has many roles in disease processes that range from auto-immune conditions such as rheumatoid arthritis to atherosclerosis. Previous work has shown that the CD163 gene can be regulated by glucocorticoids, IL-10 and other inflammatory modulators, and is highly expressed in inflamed tissues, consistent with its role in the resolution of inflammation. Staining for CD163 has been helpful in distinguishing synovial macrophages from synovial intimal fibroblasts in the setting of rheumatoid arthritis, where its specificity for macrophages was found to be superior to that of CD68, which does not discriminate between these cell types. Increased levels of CD163 were also detected in patients with microbial infections and myelomonocytic leukaemias by an enzyme-linked immunosorbent assay. Flow cytometry studies have confirmed that CD163 expression is limited to leukaemias with monocytic differentiation. Another recent study showed that all 5 cases of synovial-type giant cell tumours of the vertebral column stained for CD163. References 1. Backe E, et al., J Clin Pathol. 44(11):936-945, 1991. 2. Buechler C, et al., J Leukoc Biol. 67(1):97-103, 2000. 3. Hiraoka A, et al., Pathol Res Pract. 201(5):379-84, 2005. 4. Hogger P, et al., J Immunol. 161(4):1883-1890, 1998. 5. Kristiansen M, et al., Nature. 409(6817):198-201, 2001. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 100 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME CDX-2 (EPR2764Y) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-4380 05463491001 Rabbit Monoclonal Adenocarcinoma of Colon, Normal Colon Nuclear 50 tests IgG Colon adenoma Description CDX-2 is a caudal-related homeobox transcription factor whose expression in the adult is normally restricted to the intestinal epithelium. It is implicated in the development and maintenance of the intestinal mucosa. This protein is expressed immunohistochemically in the nuclei of normal intestinal epithelium. Loss of CDX-2 protein expression has been correlated with loss of differentiation in colorectal cancers. CDX-2 (EPR2764Y) Rabbit Monoclonal Primary Antibody has been useful in distinguishing gastro-intestinal origin of metastatic adenocarcinomas and carcinoids. A high percentage of mucinous carcinomas of the ovary also stain positively with this antibody as well as carcinomas from the upper gastro-intestinal tract. References 1. Levine PH, et al., Diagn Cytopathol. 34(3):191-5, 2006. 2. Mazziotta RM, et al., Appl Immunohistochem Mol Morphol. 13(1):55-60, 2005. 3. Saqi A, et al., Am J Clin Pathol. 123(3):394-404, 2005. 4. Erickson LA, et al., Endocr Pathol. 15(3):247-52, 2004. Chromogranin A (LK2H10) Part Number Type Control Localisation Quantity Isotype 5. Saad RS, et al., Am J Clin Pathol. 122(3):421-7, 2004. 6. Kaimaktchiev V, et al., Mod Pathol. 17(11):1392-9, 2004. 7. Groisman GM, et al., Int J Gynecol Pathol. 23(1):52-7, 2004. 8. Moskaluk CA, et al., Mod Pathol. 16(9):913-9, 2003. 9. Werling RW, et al., Am J Surg Pathol. 27(3):303-10, 2003. 760-2519 05267056001 Mouse Monoclonal Pancreas Cytoplasmic 50 tests IgG1/K Pancreatic islet cells Description Chromogranin A (LK2H10) Mouse Monoclonal Primary Antibody specifically binds to the chromogranin A protein located in the secretory granules of normal and neoplastic neuroendocrine cells. Chromogranin A is also expressed by adrenal (medulla), parathyroid, anterior pituitary cells, islet cells of the pancreas, gastro-intestinal cells, bronchial endocrine cells and thyroid C cells. Chromogranin A is expressed in tumours of neuroendocrine origin, including pheochromocytomas, pituitary adenomas, islet cell tumours, medullary thyroid carcinomas, carcinoids and Merkel cell tumours. This antibody may be used to aid in the identification of cells of normal or neoplastic neuroendocrine lineage. References 1. Wilson BS, et al., Am J Clin Pathol. 115(3): 458-468, 1984. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 101 IHC & ISH | Primary Antibodies by alphabetical listing As shown, the PATHWAY c-KIT (9.7) has the characteristic-specific doublet band of 140-145 kD in lysates from GIST 822 cells. It does not cross-react with lysates from homologous receptor tyrosine kinases PDGFR alpha, c-FMS or Flt-3. Collagen Type IV (CIV22) Part Number Type Control Localisation Quantity Isotype 3 <PREV Flt- MS c -F Rα GF PD c-K IT HOME 760-2632 05267439001 Mouse Monoclonal Muscle, Lung Basement Membrane 50 tests IgG1/K Lung Description Collagen Type IV is the major component of the basal lamina, so antibodies to this molecule confirm its presence and reveal the morphological appearance of the structure. Normal tissue stains with this antibody in a fashion consistent with the sites of mesenchymal elements and epithelial basal laminae. Collagen IV (CIV22) Mouse Monoclonal Primary Antibody can also be useful in the classification of soft tissue tumours; schwanomas, leiomyomas and their well differentiated, malignant counterparts usually immuno react with this antibody. The vascular nature of neoplasms, hemangiopericytoma, angiosarcoma and epithelioid hemangioendothelioma can be revealed by this antibody with greater reliability than non-specific stains (e.g. silver reticulum). References 1. Gould VE, et al., Pathol Annul. 11:353-386, 1976. 2. McArdle JP, et al., Int J Cancer. 34:633-638, 1984. 3. Sakr WA, et al., Hum Path. 18:1043-1050, 1987. 4. Barsky SH, et al., Am J Surg Path. 7:667-677, 1983. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 102 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> COX-2 (Cyclooxygenase 2) (SP21) Part Number Type Control Localisation Quantity Isotype 760-4254 05269148001 Rabbit Monoclonal Colon Adenocarcinoma Cytoplasmic 50 tests IgG Colon adenocarcinoma Description Cyclooxygenase 2 (COX-2) catalyses the conversion of arachidonic acid to prostaglandin H2 in the first step in the biosynthesis of prostaglandins, thromboxanes and prostacyclins. COX-2 inhibition by non-steroidal anti-inflamatory agents has been shown to decrease angiogenesis and tumour growth and promote apoptosis. COX-2 overexpression has been associated with increased microvascular density. COX-2 overexpression has also been suggested as a poor prognostic indicator in carcinomas of the colon, breast, pancreas and adenocarcinoma of the lung. References 1. Stoehlmacker J, et al., Semin Oncol. (3)suppl 6:10-16, 2003. 2. Gallo O, et al., Hum Pathol. 33(7):708-714, 2002. 3. Sano H, et al., Cancer Res. 55(17):3785-9, 1995. Cyclin D1 NEW (SP4-R) Part Number Type Control Localisation Quantity Isotype 4. Denkert C, et al., Cancer. 97(12):2978-87, 2003. 5. Sheehan KM, et al., Hum Pathol. 34:1242-1246, 2003. 790-4508 05862949001 Rabbit Monoclonal Tonsil Nuclear 50 tests IgG Description Cyclin D1 (SP4-R) Rabbit Monoclonal Primary Antibody is directed against the cyclin D1 molecule, a key cell cycle regulator, expressed primarily during the G1 phase of the cell cycle. This antibody exhibits a nuclear staining pattern and may be used to aid in the identification of mantle cell lymphoma and breast carcinoma. References 1. Milenkovic S, et al., Cell Mol Neurobiol. 28:907-913, 2008. 2. Yang K, et al., Cell Division. 1:1-8, 2006. 3. Lesage D, et al., Int J Cancer. 115:171-176, 2005. 4. Arnold A, et al. J Clin Oncol. 23:4215-4224, 2005. 5. Dobashi Y, et al., Int J Cancer. 110:532-541, 2004. 6. Yang C, et al., Urologia Internationalis. 69:190-194, 2002. 7. Aguilera NS, et al., Am J of Path. 153:1969-76, 1998 Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 103 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV Cytokeratin, CONFIRM (34βE12) Part Number Type Control Localisation Quantity Isotype 790-4373 05479266001 Mouse Monoclonal Prostate Cytoplasmic 50 tests IgG1 Prostate carcinoma Description CONFIRM Cytokeratin (34βE12) Mouse Monoclonal Primary Antibody recognises cytokeratins 1, 5, 10 and 14 of the Moll catalogue and is used as an aid in the identification of basal cells in prostate and myoepithelial cells in breast. Clone 34βE12 has been characterised as identifying high molecular weight (HMW) cytokeratins found in squamous and ductal epithelium over a wide range of organ tissues. Clone 34βE12 reacts with basal cells in normal epithelia of the prostate. References 1. Gown A, et al., Amer J Clin Pathol. 84: 413-424, 1985. 2. Brawer M, et al., Canc Res. 45: 3663-3667, 1985. 3. Moll R, et al., Cell. 31: 11-24, 1982. Cytokeratin, CONFIRM (AE1) Part Number Type Control Localisation Quantity Isotype 760-2521 05267064001 Mouse Monoclonal Prostate, Salivary Gland Cytoplasmic 50 tests IgG1 Prostate Description CONFIRM Cytokeratin (AE1) Mouse Monoclonal Primary Antibody may be used to aid in the identification of cells of normal and abnormal epithelial lineage as an aid in diagnosis of anaplastic tumours. Cytokeratin (AE1) recognises an epitope found on human callus cytokeratins; it reacts with the 56.5 kD, 50 kD, 50’ kD, 48 kD and 40 kD cytokeratins of the acidic subfamily. Because specific combinations of cytokeratin peptides are associated with different epithelial cells, these peptides are clinically important markers for classifying carcinomas (tumours of epithelial origin) and for distinguishing carcinomas from malignant tumours of non-epithelial origin such as lymphomas, melanomas and sarcomas. References 1. Robbins SL, et al., Pathol Basis of Disease 3rd Ed. W.B. Saunders, New York, 1984. 2. Woodcock-Mitchell J, et al., J Cell Biol. 95(2 Pt 1): 580-588, 1982. 3. Spagnolo DV, et al., Am J Clin Pathol. 84(6): 697-704, 1985. 4. Thomas P, et al., Hum Pathol. 18(7): 728-734, 1987. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 104 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> Cytokeratin, CONFIRM (AE3) Part Number Type Control Localisation Quantity Isotype 790-2909 05278040001 Mouse Monoclonal Prostate, Salivary Gland, Bladder Cytoplasmic 50 tests IgG1 Stratified squamous epithelium Description CONFIRM Keratin (AE3) Mouse Monoclonal Primary Antibody recognises basic cytokeratins of 65-67, 64, 59, 56 and 52 kD. The antibody is a marker used to distinguish carcinomas from non-epithelial tumours. References 1. Pinkus GS, et al., J. Histochem and Cytochem. 33(5): 465-473, 1985. 2. Weiss RA, et al., J Cell Biol. 98(4): 1397-1406, 1984. Cytokeratin NEW (CAM 5.2) Part Number Type Control Localisation Quantity Isotype 3. Tseng SC, et al., Cell. 30(2): 361-372, 1982. 4. Woodcock-Mitchell J, et al., J. Cell Biol. 95(2 pt 1):580-588, 1982. 790-4555 06478425001 Mouse Monoclonal Pancreatic Carcinoma and Colon Cytoplasmic 50 tests IgG Colon adenocarcinoma Description Cytokeratin (CAM 5.2) Mouse Monoclonal Primary Antibody is directed against cytokeratin 7 and cytokeratin 8 present on secretory epithelia but not on stratified squamous epithelia. This antibody may be used to aid in the identification of tumours of epithelial origin such as colorectal, pancreatic and non-small cell lung cancer, and in distinguishing carcinomas from other malignant tumours of non-epithelial origin. References 1. Makin CA, et al. J Clin Pathol. 37:975-983, 1984. 2. Chu PG, et al. Endocr Pathol. 20:1-10, 2009. 3. Quinlan RA, et al. Annals New York Academy of Sciences. 282306, 1985. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 105 IHC & ISH | Primary Antibodies by alphabetical listing HOME Cytokeratin (Pan) (AE1/AE3 & PCK26) Part Number Type Control Localisation Quantity Isotype <PREV 760-2595 05267145001 (50 tests); 760-2135 05266840001 (250 tests) Mouse Monoclonal Intestine, Liver Cytoplasmic 50 Tests (760-2595), 250 Tests (760-2135) IgG1 Skin Description Pan Cytokeratin (AE1/AE3/PCK26) Mouse Monoclonal Primary Antibody may be used to aid in the identification of normal and abnormal epithelial cells and to determine the lineage of poorly differentiated malignant tumours. This antibody cocktail recognises most of the acidic and all of the basic cytokeratins, making it a useful stain for nearly all epithelial tissues and their tumours. Anti-Pan Keratin (AE1/ AE3/PCK26) specifically binds to antigens located in the cytoplasm of simple and complex epithelial cells; it reacts with the 56.5kD, 50kD, 50’kD, 48kD and 40kD cytokeratins of the acidic subfamily and 65-67kD, 64kD, 59kD, 58kD, 56kD and 52kD cytokeratins of the basic subfamily. References 1. Woodkcock-Mitchell J, et al., J Cell Biol. 95(2 pt 1): 580-588, 1982. 2. Spagnolo DV, et al., Am J Clin Pathol. 84(6):,697-704, 1985. 3. Lane EB, et al., Nature. 356(6366): 244-246, 1992. 4. Sun TT, et al., Annals NY Acad Sci. 455: 307-329, 1985. 5. Eichner R, et al., Cell Biol. 98(4): 1388-1396, 1984. Cytokeratin 5/6 NEW (D5/16B4) Part Number Type Control Localisation Quantity Isotype 790-4554 06478441001 Mouse Monoclonal Prostate and Tonsil Cytoplasmic 50 tests IgG1 Lung squamous cell carcinoma Description Cytokeratin 5/6 (D5/16B4) Mouse Monoclonal Primary Antibody detects cytokeratins 5 and 6. Cytokeratin 5 is expressed in various epithelia and mesothelial cells, while cytokeratin 6 is expressed by proliferating squamous epithelium. This antibody exhibits a cytoplasmic staining pattern and may be used to aid in the identification of squamous cell carcinoma and in distinguishing malignant mesothelioma from lung adenocarcinomas. The detection of cytokeratin 5 in myoepithelial cells with this antibody may also be used to aid in the determination of breast and prostate malignancies. References 1. Pu RT, et al. Diagn Cytopathol. 36:20-25. 2008. 2. Moll R, et al. Cell. 31:11-24, 1982. 3. Clover J, et al. AntiHistopathol. 31:140-143, 1997. 4. Cury PM, et al. Mod. Pathol. 13:107-112, 2000. 5. Otterbach F, et al. Histopathol. 37:232-240, 2000. 6. Trokov K, et al. Am J Clin Pathol. 132:211-220, 2009. 7. Chu PG, et al. Mod Pathol. 15:6-10, 2002. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 106 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> Cytokeratin 7, CONFIRM (SP52) Part Number Type Control Localisation Quantity 790-4462 05986818001 Rabbit Monoclonal Glandular and Ductal Epithelium of Lung, Salivary Gland, Breast Tissue Cytoplasmic 50 tests Lung adenocarcinoma Description CONFIRM Cytokeratin 7 (SP52) Rabbit Monoclonal Primary Antibody is directed against a type II cytokeratin protein expressed by most ductal, glandular and transitional epithelia. Cytokeratin 7 exhibits a cytoplasmic localisation. This antibody may be used to aid in the identification of normal and neoplastic cells of ovary, lung and breast epithelial origin which express Cytokeratin 7, and those of colonic and prostate epithelial lineage which lack Cytokeratin 7 production. References 1. Wick MR, et al., Immunohistology of the Gastrointestinal Tract, Pancreas, Bile Ducts, Gallbladder and Liver. Diagnostic Immunohistochemistry, 2nd Edition. Philadelphia, PA. Elsevier Inc; 2006:464-465. 2. Rubin BP, et al., Euro J of Cancer Prevent. 10:77-82, 2001. 3. Wang HL, et al., Am J Surg Path. 25 (11):1380-1387, 2001. Cytokeratin 8 (35betaH11) Part Number Type Control Localisation Quantity Isotype 4. Inamura K., et al., Am J Surg Pathol. 29:660-665, 2005. 5. Rekhi B, et al., Diagn Pathol. 3:39-45, 2008. 6. Rossi G, et al., J Thorac Oncol. 2:115–120, 2007. 7. Sack MJ, et al., Diagn Cytopathol. 16:132-136, 1997. 8. Tsao SC, et al., Kaohsiung J Med Sci. 23:325–331, 2007. 760-2637 05267471001 Mouse Monoclonal Prostate Cytoplasmic 50 tests IgM/K Andenocarcinoma Description Cytokeratin 8 is reactive with the majority of epithelium and epithelial tumours; non-squamous tumours stain positive and squamous tumours stain negative. This antibody stains positive for adenocarcinomas of the breast, ovary, gastro-intestinal tract, thyroid, pancreas, bile duct and salivary glands. This antibody does not react with skeletal muscle or nerve cells. References 1. Gown AM, et al., Am J Pathol. 114:309, 1984. 2. O’Malley FP, et al., Virch Arch. A. 417:191, 1990. 3. Mahul B, et al., Arch Pathol Lab Med. Vol. 118:260-264, 1994. 4. Wojno KJ, et al., Am J Surg Pathol. 19(3):251-60, 1995. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 107 IHC & ISH | Primary Antibodies by alphabetical listing HOME Cytokeratin 8 & 18 (B22.1 & B23.1) Part Number Type Control Localisation Quantity Isotype <PREV 760-4344 05269776001 Mouse Monoclonal Pancreas, Prostate, Salivary Gland Cytoplasmic 50 tests IgG1 Breast Description Cytokeratin 8 & 18 (B22.1 & B23.1) Mouse Monoclonal Primary Antibody is a cocktail of two mouse monoclonal antibodies. Cytokeratins 8 & 18 can be found in most simple epithelium, e.g. thyroid, female breast, gastro-intestinal tract and respiratory tract. Adenocarcinomas and most non-keratinising squamous carcinomas will stain, but keratinising squamous carcinomas will not. This cocktail is used when attempting to demonstrate the presence of Paget cells; there is very little keratin 18 in the normal epidermis so this will only stain Paget cells. This approach facilitates the interpretation using immunostains and is more sensitive than mucin histochemistry. References 1. Angus B, et al., Journal of Pathology. 155:377-384, 1987. 2. Corson JM., Pathol Annual 21 (part 2). 47-81, 1986. Cytokeratin 10 NEW (SP99) Part Number Type Control Localisation Quantity Isotype 3. Sasaki M et al., Histopathology. 32(3):199-208, 1998. 790-4562 06425135001 Rabbit Monoclonal Skin Cytoplasmic 50 tests Rabbit Ig Rectal squamous cell carcinoma Description Cytokeratin 10 (SP99) Rabbit Monoclonal Primary Antibody is directed against the 56.5kD member of the type 1 cytokeratin family, cytokeratin 10. Cytokeratin 10 is expressed in keratinising stratified epithelia, but is absent from the basal layer, in various organs including the skin. Cytokeratin 10 (SP99) antibody exhibits a cytoplasmic staining pattern and may be used to aid in the identification of welldifferentiated squamous carcinomas of the cervix and anus. References 1. Moll R, et al. Cell. 31:11-24, 1982. 2. Fillies T, et. al. BMC Can. 6:1186-1194, 2006. 3. Parks JM, et al. Human Path. 41:431-437, 2010. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 108 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME Cytokeratin 14 (LL002) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-4251 05269113001 Mouse Monoclonal Squamous Mucosa, Squamous Carcinoma Cytoplasmic 50 tests IgG3 Squamous mucosa Description Cytokeratin 14 is a 50 kD polypeptide found in basal cell of squamous epithelia, some glandular epithelia, myoepithelium and mesothelial cells. Cytokeratin 14 (LL002) Mouse Monoclonal Primary Antibody has been demonstrated to be useful in differentiating squamous cell carcinomas from other epithelial tumours. This antibody has also been useful in separating oncocytic tumours of the kidney from its renal mimics, as well as in determining metaplastic carcinomas of the breast. References 1. Reis-Filho JS, et al., Appl Immunohistochem Mol Morphol. 11(1):1-8, 2003. 2. Chu PG, et al., Histopathology. 39(1):9-16, 2001. Cytokeratin 17 NEW (SP95) Part Number Type Control Localisation Quantity Isotype 3. Chu PG, et al., Histopathology. 39(5):455-62, 2001. 4. Dabbs DJ, et al., Diagnostic Immunohistochemistry, ChurchillLivingstone, Philadelphia, 2002; 166-176. 790-4560 06373658001 Rabbit Monoclonal Cervical Carcinoma, Normal Skin Membranous, Cytoplasmic 50 tests Rabbit Ig Rectal squamous cell carcinoma Description Cytokeratin 17 (SP95) Rabbit Monoclonal Primary Antibody is directed against Cytokeratin 17 expressed in basal cells of complex epithelia, glandular epithelium with myoepithelial component and transitional and pseudostratified epithelia. This antibody may be used to aid in the identification of squamous cell carcinomas in various tissues including the cervix, lung and oral cavity. References 1. Troyanovsky S, et al. J Cell Sci. 93:419-426, 1989. 2. Quinlan R, et al. Ann NY Acad Sci. 455:282-306, 1985. 3. Martens J, et al. Anticancer Res. 24:771-776, 2004. 4. Toyoshima T, et al. J Cancer Res. Clin. Oncol. 134:515-521, 2008. 5. Blobel G, Moll, et al. Cell Pathol. 45:407-429, 1984. 6. Rijn M, et al. Am J Pathol. 161,6:1991-1996, 2002. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 109 IHC & ISH | Primary Antibodies by alphabetical listing HOME Cytokeratin 19 (A53-B/A2.26) Part Number Type Control Localisation Quantity Isotype <PREV 760-4281 05269440001 Mouse Monoclonal Colon and Thyroid Carcinoma Cytoplasmic 50 tests IgG1 Colon carcinoma Description Cytokeratin 19 (A53-B/A2.26) Mouse Monoclonal Primary Antibody reacts with a wide variety of epithelium and epithelial malignancies including adenocarcinomas of the colon, stomach, pancreas, biliary tract, liver and breast. Perhaps the most useful application is the identification of thyroid carcinoma of the papillary type, although, follicular carcinoma is also labelled by this antibody approximately 5060% of the time. References 1. Zubair W, et al., Hum Pathol. 30:1166-1171, 1999. 2. Judkins AR, et al., Hum Pathol. 30:1373-1376, 1999. 3. Cerilli LA, et al., Am J Clin Pathol. 118:186-193, 2002. 4. Nasser SM, et al., Cancer (Cancer Cytopathol). 90:307-11, 2000. Cytokeratin 20, CONFIRM (SP33) Part Number Type Control Localisation Quantity 790-4431 05587760001 Rabbit Monoclonal Colon Adenocarcinoma Cytoplasmic 50 tests Colon carcinoma Description CONFIRM Cytokeratin 20 (SP33) Rabbit Monoclonal Primary Antibody is directed against a type I cytokeratin protein of mature enterocytes and goblet cells of the gastric and intestinal mucosa. This antibody produces a cytoplasmic staining pattern and may be used to aid in the identification of normal cytokeratin 20 expressing cells and neoplastic cells of colonic epithelial lineage. References 1. Zhou Q, et al., Mol Biology of the Cell. 14(7):2959-71, 2003. 2. Moll R, et al., Differentiation. 53(2):75-93, 1993. 3. Moll R, et al., Am J of Path. 140(2):427-447, 1992. 4. Chan J, et al., Am J of Surg Path. 21(2):226-234, 1997. 5. Zhou Q, et al., J of Biol Chem. 281(24):16453-16461, 2006. 6. Kyung-Joon M, et al., Path Res and Practice. 202(7):531-535, 2006. 7. Tot T, Annals of Diag Path. 3(6):350-356, 1999. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 110 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME Desmin, CONFIRM (DE-R-11) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-2513 05267005001 Mouse Monoclonal Intestine Cytoplasmic 50 tests IgG1/K Rhabdomyosarcoma Description CONFIRM Desmin (DE-R-11) Mouse Monoclonal Primary Antibody identifies normal muscle cells and myogenic neoplasms bearing the desmin antigen. The most obvious application of desmin antibodies is in the characterisation of myogenic neoplasms or in the recognition of myogenic cell lines in mixed sarcomas. Among neoplasms, carcinomas do not react with desmin antibodies, leiomyosarcomas and rhabdomyosarcomas are positive and other sarcomas (with some exceptions) are negative. Myogenic sarcomas can be classified as such due to their positive staining with antibodies to muscle (specific) actin and desmin. Because of the different sensitivities and specificities of these antibodies, they are best used in combination. References 1. Debus E, et al., EMBO J. 2(12): 2305-2312, 1983. 2. True LD, Atlas of Diag Immuno Histopathol Lippincott Co Philadelphia, 1990. DOG1 NEW (SP31) Part Number Type Control Localisation Quantity 3. Taylor RT, et al., Immunomicroscopy 2nd Edition, WB Saunders Co., Philadelphia, 1994. 760-4590 06433109001 Rabbit Monoclonal GIST Cytoplasmic, Membranous 50 tests GIST Description DOG1 (SP31) Rabbit Monoclonal Primary Antibody is used as an aid in the identification and diagnosis of gastro-intestinal stromal tumours (GIST) within the context of an antibody panel, the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist. References 1. Espinosa, I et al. Am J Surg Pathol. 32(2):210-8, 2008. 2. Miwa, S et al. Mutation. J Gastroen-terol. 43(7):531-7, 2008. 3. Parfitt, JR et al. Gastrointestinal. Histopathology. 52(7):816-23, 2008. 4. West, RB et al. Am J Pathol. 165(1):107-13, 2004. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 111 IHC & ISH | Primary Antibodies by alphabetical listing HOME E-Cadherin (36) Part Number Type Control Localisation Quantity Isotype <PREV 790-4497 05905290001 Mouse Monoclonal Ductal Breast Carcinoma Membranous 50 tests IgG2a/k Breast carcinoma Description E-Cadherin (36) Mouse Monoclonal Primary Antibody is directed against human transmembrane protein E-Cadherin expressed as a part of the cell-cell adhesion complex in epithelial tissues. Reduction or loss of expression is associated with invasive carcinoma and possibly metastasis in a variety of carcinomas. This antibody may be used to aid in the differentiation of in situ and/or invasive lobular carcinoma from in situ and/or invasive ductal carcinoma of the breast. References 1. Berx G, et al., Breast Cancer Res. 3:289-293, 2001. 2. Van Roy F, et al., Cell Mol Life Sci. 65:3756-3788, 2008. 3. Beavon IRG., European Journal of Cancer. 36:1607-1620, 2000. 4. Siitonen SM, et al., Am J Clin Pathol. 105: 394-402, 1996. 5. Geza A, et al., Am J Clin Pathol. 115:85-98, 2001. E-Cadherin (EP700Y) Part Number Type Control Localisation Quantity Isotype 6. Choi YJ, et al., Mod Pathol. 21:1224-1237, 2008. 7. Qureshi HS, et al., Am J Clin Path. 125:377-385, 2006. 8. Kowalski PJ, et al., Breast Cancer Res. 5:R217-R222, 2003. 9. Abutaily AS, et al., J Pathol. 201:355-362, 2003. 760-4440 05973872001 Rabbit Monoclonal Pancreas, Lung Adenocarcinoma, Breast Membranous 50 tests IgG Infiltrating carcinoma of the breast Description E-Cadherin is an adhesion protein that is expressed in cells of epithelial lineage. E-Cadherin (EP700Y) Rabbit Monoclonal Primary Antibody stains positively in glandular epithelium as well as adenocarcinomas of the lung, GI tract and ovary. It has been useful in distinguishing adenocarcinoma from mesothelioma. Another application involves the differentiation of ductal (which stains positive) vs. lobular cancer of the breast. It has also been shown to be positive in some thyroid carcinomas. Loss of E-Cadherin expression has been suggested to be a poor prognostic sign in breast carcinoma and non-small cell lung carcinoma (NSCLC). References 1. Krishnadath KK, et al., J Pathol. 182(3):331-8, 1997. 2. Schofield K, et al., Cancer. 81(5):293-8, 1997. 3. Han AC, et al., Hum Pathol. 28(6):641-5, 1997. 4. Simsir A, et al., Diagn Cytopathol. 20(3):125-30, 1999. 5. Han AC, et al., Cancer. 87(2):83-6, 1999. 6. Lear MP, et al., Histopathology. 32(3):209-16, 1998. 7. Karayiannakis AG, et al., Hepatogastroenterology. 45(24): 2437-42, 1998. 8. Peralta Soler A, et al., Hum Pathol. 28(6):734-9, 1997. 9. Abutaily AS, et al., J Clin Pathol. 55(9):662-8, 2002. 10. Wahed A, et al., Ann Diagn Pathol. 6(6):349-51, 2002. 11. Acs G, et al., Am J Clin Pathol. 115(1):85-98, 2001. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 112 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> EGFR (Epidermal Growth Factor Receptor), CONFIRM (3C6) Part Number Type Control Localisation Quantity Isotype 790-2988 05278341001 Mouse Monoclonal Colorectal Adenocarcinoma, Skin Membranous 50 tests IgG1 Squamous cell carcinoma Description CONFIRM Epidermal Growth Factor Receptor (EGFR) (3C6) Mouse Monoclonal Primary Antibody is directed against the extracellular domain of human EGFR, a protein of 170 kD. The antibody also recognises the type III variant of 145 kD. EGFR is a member of the receptor tyrosine kinase HER family. Also known as HER1, EGFR is structurally related to HER2, HER3 and HER4. Members of this family are capable of forming heterodimers to elicit signal transduction. EGFR is expressed at low levels in most normal epithelial tissues, but can be overexpressed in cancers of the breast, brain, bladder, lung, gastric, head and neck, oesophagus, cervix, ovary, endometrium and particularly in squamous cell carcinomas. References 1. Ciardello F, et al., Eur J Cancer. 39:1348-54, 2003. EGFR (Epidermal Growth Factor Receptor), CONFIRM (5B7) Part Number Type Control Localisation Quantity 790-4347 05278457001 Rabbit Monoclonal Skin, Non-Small Cell Lung Carcinoma, Placenta Cytoplasmic, Membranous 50 tests Squamous cell carcinoma, lung Description CONFIRM EGFR (5B7) Rabbit Monoclonal Primary Antibody is produced against a synthetic peptide from the carboxy terminal (cytoplasmic) region of EGFR. The epitope recognised by EGFR (5B7) is associated with an internal domain of EGFR and therefore EGFR staining with antibodies that recognise extracellular domains may not always correlate with EGFR (5B7) staining. EGFR is a member of the receptor tyrosine kinase HER family. Also known as HER 1, EGFR is structurally related to HER 2, HER 3 and HER 4. Members of this protein family are capable of forming heterodimers to mediate signal transduction. EGFR is expressed at low levels in most normal epithelial tissues, but can be overexpressed in cancers of the breast, brain, bladder, lung, gastric, head and neck, oesophagus, cervix, ovary, endometrium and particularly in squamous cell carcinomas. References 1. Ciardello F, et al., Eur J Cancer. 39:1348-54, 2003. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 113 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV EMA (Epithelial Membrane Antigen), CONFIRM (E29) Part Number Type Control Localisation Quantity Isotype 790-4463 05878900001 Mouse Monoclonal Normal Pancreas Cytoplasmic, Membranous 50 tests IgG2a Breast, ductal carcinoma Description CONFIRM EMA (E29) Mouse Monoclonal Primary Antibody is directed against epithelial membrane antigen expressed on the apical surface of glandular epithelia. This glycoprotein is primarily membrane localised on normal and tumour tissue, although it may exhibit a cytoplasmic localisation in less differentiated carcinomas. This antibody may be used to aid in the identification of epithelial membrane antigen in adenocarcinomas derived from secretory epithelia, malignant mesothelioma, renal cell carcinomas and meningiomas. References 1. Heyderman E, et al., Br J Cancer. 52:355-361, 1985. 2. Cordell J, et al., Br J Cancer. 52:347-354, 1985. 3. Metze D, et al., J Cutan Pathol. 23:518-529, 1996. 4. Dejmek A, et al., Cytopathol. 11:8-17, 2000. 5. Murakata LA, et al., Mod Pathol. 13:874-881, 2000. 6. Schnitt SJ, et al., Amer J Surg Pathol. 10:640-649, 1986. 7. Gupta RK, et al., Cytopathol. 11:312-321, 2000. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 114 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> Ep-CAM/Epithelial Specific Antigen (Ber-EP4) Part Number Type Control Localisation Quantity Isotype 760-4383 05435676001 Mouse Monoclonal Columnar Epithelium, Adenocarcinoma Cytoplasmic 50 tests IgG1/K Colon carcinoma Description Ep-CAM consists of two glycoproteins, 34 and 39 kDa, sometimes designated epithelial antigen, epithelial specific antigen and epithelial glycoprotein. The glycoproteins are located on the cell membrane surface and in the cytoplasm of virtually all epithelial cells with the exception of most squamous epithelia, hepatocytes, renal proximal tubular cells, gastric parietal cells and myoepithelial cells. However, focal positivity may be seen in the basal layer of squamous cell epithelium of endoderm (e.g. palatine tonsils) and mesoderm (e.g. uterine cervix). In liver lesions like hepatitis and cirrhosis, the hepatocytes frequently become Ep-CAM positive. Normal mesothelial cells are EpCAM negative, but may express focal reaction when undergoing reactive changes. Mesenchymal cells and cells from the neural crest are negative, with the exception of olfactory neurons. Ep-CAM is found in the large majority of adenocarcinomas of most sites (50-100% in various studies) as well as neuroendocrine tumours, including small cell carcinoma. Renal cell carcinoma and hepatocellular carcinoma stain in about 30% of the cases. Squamous cell carcinoma of endoderm and mesoderm is usually Ber-EP4 positive, while that of ectoderm is negative. Basal cell and basosquamous carcinoma are Ber-EP4 positive in almost all cases. Choroid plexus papilloma and carcinoma are usually negative. Malignant mesothelioma (epithelioid and biphasic) is Ep-CAM positive in 4-26% of the cases. The staining is usually focal, but may occasionally be widespread. Synovial sarcoma (epitheloid and biphasic) and desmoplastic small round cell tumour stain for Ep-CAM in most cases. Seminoma, embryonal carcinoma, yolk sac tumour and choriocarcinoma reveal Ber-EP4 positivity in a minor proportion of cases. Among neural tumours, Ep-CAM positivity is seen only in olfactory neuroblastoma. Ep-CAM can be of great help in the differential diagnosis of malignant involvement in the peritoneal and pleural cavities. The lack of reactivity in the majority of malignant mesothelioma can in an appropriate panel be utilised in the discrimination between this tumour and adenocarcinoma. References 1. Latza, et al., J Clin Pathol. 43:213-19, 1990. 2. Ma CK, et al., Am J Clin Pathol. 99(5):551-7, 1993. 3. Carella R, et al., Am J Surg Pathol. 25(1):43-50, 2001. 4. Ordóñez NG, Adv Anat Pathol. 13(1):16-25, 2006. 5. Ordóñez NG, Mod Pathol. 19(3):417-28, 2006. 6. Ordonez NG, Am J Clin Pathol. 109(1):85-89, 1998. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 115 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV Epithelial Related Antigen NEW (MOC-31) Part Number Type Control Localisation Quantity Isotype 790-4561 06374409001 Mouse Monoclonal Kidney, Breast, Lung and Colon Membranous, Cytoplasmic 50 tests IgG1 Lung adenocarcinoma Description Epithelial Related Antigen (MOC-31) Mouse Monoclonal Primary Antibody is directed against the 40kD epithelial cell adhesion molecule, Epithelial Related Antigen, expressed in most normal epithelial cells in tissues including lung, breast, pancreas and colon. This antibody exhibits a membranous and/or cytoplasmic staining pattern in neoplastic and normal tissue. Epithelial Related Antigen (MOC-31) antibody may be used as an aid in the differentiation of lung adenocarcinoma and mesothelioma. References 1. Oates J, et al. Histopathology. 36:341-347, 2000. 2. Morrison C, et al. Mod Pathol. 15:1279-1287, 2002. 3. Hecht JL, et al. Cancer Cytopathology. 108:56-59, 2005. 4. De Leij L, et al. Int J Cancer Suppl. 8:60-63, 1994. 5. Stauss H, et al. CRC Press; 2003. 6. Ordońez N. Am J Surg Pathol. 27:1031-1051, 2003. ERG NEW (EPR3864) Part Number Type Control Localisation Quantity 7. Pu RT, et al. Diagnostic Citopathology. 36:20-25, 2007. 8. Porcell AI, et al. Mod Pathol. 13:773-778, 2000. 9. King JE, et al. Histopathology. 48:223-232, 2006. 10. Winter MJ, et al. Am J Pathol. 163:2139-2148, 2003. 11. Bartnetson RJ, et al. Am J Clin Pathol. 125:67-76, 2006. 790-4576 06478450001 Rabbit Monoclonal Spleen Nuclear, Cytoplasmic 50 tests Prostate carcinoma Description ERG (EPR3864) Rabbit Monoclonal Primary Antibody is directed against the C-terminus of the ETS transcription regulator, ERG and is capable of detecting both wildtype ERG and truncated ERG resulting from ERG gene rearrangement. This antibody exhibits a nuclear staining pattern and may be used to aid in the identification of prostate adenocarcinomas through the detection of truncated ERG. References 1. Mehra R, et al. Mod Path, 20:538-544, 2007. 2. Perner S, et al. Am J Surg Pathol, 31:882-888. 2007. 3. Carver B, et al. Nature Genet. 41(5):619-624. 2009. 4. Mosquera J-M, et al. J Pathol. 212:91-101. 2007. 5. Park K, et al. Neoplasia12, (7):590-598. 2010. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 116 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> Estrogen Receptor (ER), CONFIRM (SP1) Part Number Type Control Localisation Quantity Isotype 790-4324 05278406001 (50 tests); 790-4325 05278414001 (250 tests) Rabbit Monoclonal Breast Nuclear 50 Tests (790-4324), 250 Tests (790-4325) IgG Breast lobular carcinoma Description CONFIRM Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody (IgG) is intended for the qualitative detection of estrogen receptor (ER) antigen. ER (SP1) antibody is directed against an epitope present on human ER protein located in the nucleus of ER positive normal and neoplastic cells. This antibody is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. References 1. Huang Z, et al., Appl Immun Mol Morph. 13(1): 91-5, 2005. 2. PDQ. http://icisun.nci.nih…t_cancer_Physician.html. 3. Stierer M, et al., Cancer Res and Treat. 36:11-21, 1995. 4. Cheang M, et al., J Clin Oncol. 24:5637-5644, 2006. Factor VIII Related Antigen (polyclonal) Part Number Type Control Localisation Quantity 760-2642 05267528001 Rabbit Polyclonal Skin, Placenta Cytoplasmic 50 tests Placenta Description Factor VIII-Related Antigen Rabbit Polyclonal Primary Antibody reacts with endothelial cells and neoplastic blood cells. This antibody has helped to establish the endothelial nature of some lesions of disputed histogenesis, e.g. Kaposi’s sarcoma and cardiac myxoma. Not all endothelial cells synthesise (or store) this molecule; therefore, it should be expected that not all tumours of endothelial differentiation (benign or malignant) react with this antigen. References 1. Wick MR, et al., Lab Invest. 52:75A, 1985. 2. Bhawan J, et al., Cancer. 55:570-576, 1985. 3. Ansell J, et al., Cancer. 50:1506-1512, 1982. 4. Fulling KH, et al., Cancer. 51:1107-1118, 1983. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 117 IHC & ISH | Primary Antibodies by alphabetical listing HOME Factor XIIIa (AC-1A1) Part Number Type Control Localisation Quantity Isotype <PREV 760-4384 05435692001 Mouse Monoclonal Dermatofibroma Cytoplasmic 50 tests IgG1 Dermatofibroma Description Factor XIIIa is a blood proenzyme that has been identified in platelets, megakaryocyte and fibroblastlike mesenchymal or histiocytic cells present in the placenta, uterus and prostate; it is also present in monocytes and macrophages and dermal dendritic cells. Factor XIIIa antibody has been found to be useful in differentiating between dermatofibroma (90% +), dermatofibrosarcoma protuberans (25% +) and desmoplastic malignant melanoma (0% +). Factor XIIIa positivity is also seen in capillary hemagioblastoma (100% +), hemangioendothelioma (100% +), hemangiopericytoma (100% +), xanthogranuloma (100% +), xanthoma (100% +), hepatocellular carcinoma (93% +), glomus tumour (80% +) and meningioma (80% +). References 1. Abenoza P, et al., Am J Dermatopathol. 15(5):429-34, 1993. 2. Anstey A, et al., Am J Dermatopathol. 16(1):14-22, 1994. 3. Glusac EJ, et al., Am J Surg Pathol. 18(6): 583-90, 1994. 4. Nemes Z, Hum Pathol. 23(7):805-10, 1992. 5. Demetris AJ, et al., Am J Surg Pathol. 21(3):263-70, 1997. Factor XIIIa (EP3372) Part Number Type Control Localisation Quantity Isotype 6. Horenstein MG, et al., Am J Surg Pathol. 24(7):996-1003, 2000. 7. Kraus MD, et al., Am J Dermatopathol. 23(2):104-11, 2001. 8. Dehner LP, Am J Surg Pathol. 27(5):579-93, 2003. 9. Deguchi M, et al., Arch Dermatol Res. 294(7):297-302, 2002. 760-4441 05922470001 Rabbit Monoclonal Dermatofibroma Cytoplasmic 50 tests IgG Placenta, normal Description Factor XIIIa is a blood proenzyme that has been identified in platelets, megakaryocytes and fibroblast-like mesenchymal or histiocytic cells present in the placenta, uterus and prostate; it is also present in monocytes and macrophages and dermal dendritic cells. Factor XIIIa antibody has been found to be useful in differentiating between dermatofibroma (90% +), dermatofibrosarcoma protuberans (25% +) and desmoplastic malignant melanoma (0% +). Factor XIIIa positivity is also seen in capillary hemagioblastoma (100% +), hemangioendothelioma (100% +), hemangiopericytoma (100% +), xanthogranuloma (100% +), xanthoma (100% +), hepatocellular carcinoma (93% +), glomus tumour (80% +) and meningioma (80% +). References 1. Abenoza P, et al., Am J Dermatopathol. 15(5):429-34, 1993. 2. Anstey A, et al., Am J Dermatopathol. 16(1):14-22, 1994. 3. Glusac EJ, et al., Am J Surg Pathol. 18(6):583-90, 1994 4. Nemes Z, et al., Hum Pathol. 23(7):805-10, 1994. 5. Demetris AJ, et al., Am J Surg Pathol. 21(3):263-70, 1997. 6. Horenstein MG, et al., Am J Surg Pathol. 24(7):996-1003, 2000. 7. Kraus MD, et al., Am J Dermatopathol. 23(2):104-11, 2001. 8. Dehner LP, et al., Am J Surg Pathol. 27(5):579-93, 2003. 9. Deguchi M, et al., Arch Dermatol Res. 294(7):297-302, 2002. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 118 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME Fascin (55k-2) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-2702 05268117001 Mouse Monoclonal Hodgkin’s Lymphoma, Lymph Node Cytoplasmic 50 tests IgG1 Hodgkin’s lymphoma, Reed-Sternberg cells Description Fascin (55k-2) Mouse Monoclonal Primary Antibody is a very sensitive marker for Reed-Sternberg cells and variants in nodular sclerosis, mixed cellularity and lymphocyte depletion Hodgkin’s disease. It is uniformly negative in lymphoid cells, plasma cells and myeloid cells. Fascin antibody is positive in dendritic cells. This marker may be helpful in distinguishing between Hodgkin’s disease and non-Hodgkin’s lymphoma in difficult cases. Also, the lack of expression of fascin in the neoplastic follicles in follicular lymphoma can be helpful in distinguishing these lymphomas from reactive follicular hyperplasia in which the number of follicular dendritic cells is normal or increased. References 1. Pinkus GS, et al., Am J of Pathol. 150(2):543-562, 1997. FSH (Follicle Stimulating Hormone) (polyclonal) Part Number Type Control Localisation Quantity 760-2710 05268192001 Rabbit Polyclonal Normal Pituitary Cytoplasmic 50 tests Pituitary Description Follicle Stimulating Hormone (FSH) Rabbit Polyclonal Primary Antibody is a useful marker in classification of pituitary tumours and the study of pituitary disease. It reacts with FSH-producing cells (gonadotrophs). References 1. Schmid M, et al., Pathol Res Pract. 197(10):663-9, 2001. 2. Uccella S, et al., Pituitary. 3(3):131-9, 2000. 3. La Rosa S, et al., Virchows Arch. 437(3):264-9, 2000. 4. Zheng W, et al., Gynecol Oncol. 76(1):80-8, 2000. 5. Ben-Josef E, et al., J Urol. 161(3):970-6, 1999. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 119 IHC & ISH | Primary Antibodies by alphabetical listing HOME Galectin-3 (9C4) Part Number Type Control Localisation Quantity Isotype <PREV 760-4256 05269164001 Mouse Monoclonal Papillary or Follicular Carcinoma of Thyroid Cytoplasmic 50 tests IgG1 Papillary carcinoma of the thyroid Description Galectin-3 is a 31 kD beta-galactosidase binding lectin. It has been associated with binding to the basement membrane glycoprotein laminin. Galectin-3 (9C4) Mouse Monoclonal Primary Antibody has been demonstrated to be valuable in differentiating between benign and malignant thyroid neoplasms in both histologic sections and fine needle aspiration biopsy material. Galectin-3 antibody has also been useful in identifying anaplastic large cell lymphoma. References 1. Inohara H, et al., Cancer. 85:2475-84, 1999. 2. Herrmann ME, et al., Arch Pathol Lab Med. 126:710-713, 2002. 3. Papotti M, et al., Eur J of Endo. 147:515-521, 2002. Gastrin (polyclonal) Part Number Type Control Localisation Quantity 4. Bartolazzi A, et al., Lancet. 357:1644-50, 2001. 5. Orlandi F, et al., Cancer Res. 58:3015-3020, 1998. 6. Gasbarri A, et al., J Clin Oncol. 17:3494-3502, 1999. 760-2643 05267536001 Rabbit Polyclonal Stomach Cytoplasmic 50 tests Stomach Description Gastrin Rabbit Polyclonal Primary Antibody gives positive staining of G cells of human antral/pyloric mucosa and cells producing gastrin or a structural gastrin analogue as is seen in the stomach; no staining of other cells or tissue types has been observed. This antibody may react with sulphated and non-sulphated forms of gastrin. The antibody cross-reacts with more than 50% of the present choleocystokinin octa peptide. References 1. Rehfeld JF, et al., J Biol Chem. 256:10426-9, 1981. 2. Kirchner T, et al., Am J Surg Path. 11:909-17, 1987. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 120 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME GCDFP-15 (EP1582Y) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-4386 05463530001 Rabbit Monoclonal Breast, Breast Carcinoma Cytoplasmic 50 tests IgG Breast carcinoma Description GCDFP-15 is a 15,000-dalton glycoprotein which is localised in the apocrine metaplastic epithelium lining breast cysts and in apocrine glands in the axilla, vulva, eyelid and ear canal. Approximately 70% of breast carcinomas stain positive with antibody to GCDFP-15. Colorectal carcinomas, as well as mesotheliomas, do not stain with this antibody. Lung adenocarcinoma rarely stains with this antibody. References 1. Mazoujian G, et al., Am J Dermatopathol. 10(1):28-35, 1988. 2. Ansai S, et al., Am J Dermatopathol. 17(3):249-55, 1995. 3. Mazoujian G, et al., Am J Pathol. 110(2):105-12, 1983. 4. Wich MR, et al., Hum Pathol. 20(3):281-7, 1989. 5. Cohen C, et al., Arch Pathol Lab Med. 117(3):291-4, 1993. 6. Raju U, et al., Mod Pathol. 6(5):516-20, 1993. 7. Bhargava R, et al., Am J Clin Pathol. 127:103-113, 2007. 8. Tornos C, et al., Am J Surg Pathol. 29(11):1482-9, 2005. 9. Takeda Y, et al., Arch Pathol Lab Med. 132(2):239-43, 2008. 10. Liegl B, et al., Histopathology. 50(4):439-47, 2007. GFAP (Glial Fibrillary Acidic Protein) (EP672Y) Part Number Type Control Localisation Quantity Isotype 760-4345 05269784001 Rabbit Monoclonal Brain Cytoplasmic 50 tests IgG Astrocytoma Description GFAP (EP672Y) Rabbit Monoclonal Primary Antibody detects astrocytes, Schwann cells, satellite cells, enteric glial cells and some groups of ependymal cells. This marker is mainly used to distinguish neoplasms of astrocytic origin from other neoplasms in the central nervous system. References 1. Viale G, et al., Virchow’s Arch A Pathol Anat. 418:339-348, 1991. 2. Choi BH, et al., Science. 223:407-409, 1984. 3. Funata N, et al., Bull Tokyo Med Dent Univ. 32:9-18, 1985. 4. Jessen KR, et al., J Neurosci. 3:2206-2218, 1983. 5. Kawahara E, et al., Am J Surg Pathol. 12:115-120, 1988. 6. Nagashima G, et al. Clin Neurol Neurosurg. 2002 May;104(2):125-31. 7. Regner A, et al. J Neurotrauma. 2001 Aug;18(8):783-92. 8. Giangaspero F, et al. Acta Neuropatahol (Berl). 2002 Feb;103(2):152-6. Epub 2001 Nov 10. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 121 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV GH (Growth Hormone) (polyclonal) Part Number Type Control Localisation Quantity 760-2804 05268257001 Rabbit Polyclonal Normal Pituitary Cytoplasmic 50 tests Pituitary Description Growth Hormone Rabbit Polyclonal Primary Antibody is a useful marker in classification of pituitary tumours and the study of pituitary disease (acromegaly). It reacts with GH-producing cells. References 1. Fukaya T, et al., Cancer. 45:1598, 1980. 2. Kovacs K, et al., Virch Arch Pathol Anat. 395:59, 1982. 3. Cunha KS, et al., J Clin Pathol. 56(10):758-63, 2003. Glucagon (polyclonal) Part Number Type Control Localisation Quantity 4. Chopin LK, et al., Growth Horm. IGF. Res. 12(2):126-36, 2002. 5. Matsuno A, et al., Pathol Res Pract. 197(1):13-20, 2001. 6. Garcia-Caballero T, et al., Endocrine. 12(3):265-71, 2000. 760-2644 05267544001 Rabbit Polyclonal Pancreas Cytoplasmic 50 tests Pancreas, islets of Langerhans Description Glucagon Rabbit Polyclonal Primary Antibody detects glucagon-secreting cells and tumours such as glucagonomas. Studies show that approximately 80% of glucagonomas are malignant and these patients have a syndrome often initially recognised by dermatologists. Symptoms include necrolytic migratory erythema as well as diabetes, anemia, stomatitis, weight loss, frequent venous thromboses and in some instances diarrhoea and psychiatric disturbances. The diagnosis may be readily confirmed by the demonstration of elevated plasma glucagon concentration. References 1. Unger RH, et al., N Eng J Med. 304:1518-1524, 1981. 2. Larson L, et al., Hum Pathol. 9:401-416, 1978. 3. Erlandsen SL, Williams and Wilkins, Baltimore, 40-155, 1980. 4. Friesen SR, et al., N Eng J Med. 306:580-590, 1982. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 122 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME GLUT 1 NEW (polyclonal) Part Number Type Control Localisation Quantity <PREV NEXT> 760-4526 06419178001 Rabbit Polyclonal Malignant Mesothelioma, Colorectal Carcinoma Membranous 50 tests Description Glucose transporter type I (GLUT1), a prototype member of GLUT super family, reacts with a 55 kD protein and is a membrane-associated erythrocyte glucose transport protein. It is a major glucose transporter in the mammalian blood-brain barrier and also mediates glucose transport in endothelial cells of the vasculature, adipose tissue and cardiac muscle. GLUT1 is detectable in many human tissues including those of colon, lung, stomach, oesophagus and breast. GLUT1 is overexpressed in malignant cells and in a variety of tumours that include breast, pancreas, cervix, endometrium, lung, mesothelium, colon, bladder, thyroid, bone, soft tissues and oral cavity. References 1. Kato Y, et. al., Mod Pathol. 20:215-220, 2007. 2. Afify A, et. al., Acta Cytol. 49:621-626, 2005. Glycophorin A (GA-R2 & HIR2) Part Number Type Control Localisation Quantity Isotype 3. Parente P, et. al. J Exp Clin Can Res. 27;34, 2008. 4. Zimmerman RL, et. al., Cancer. 96: 53-57, 2002. 760-4257 05269172001 Mouse Monoclonal Bone Marrow Membranous 50 tests IgG2b/K Bone marrow, erythroid elements Description Glycophorin A is a sialoglycoprotein present on human red blood cells and their precursors. Glycophorin A (GA-R2 & HIR2) Mouse Monoclonal Primary Antibody has been used to characterise erythroid cell development and in the diagnosis of erythroid leukaemia. References 4. Chang CC, et al., Am J Clin Pathol. 114(5):807-11, 2000. 1. van der Valk P, et al., Am J Surg Pathol. 13(2): 97-106, 1989. 2. Muller M, et al., J Vet Med A Physiol Pathol Clin Med. 48(1):51-7, 2001. 5. Muller M, et al., J Vet Med A Physiol Pathol Clin Med. 48(1):51-7, 2001. 3. Sadahira Y, et al., J Clin Pathol. 52(12):919-21, 1999. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 123 IHC & ISH | Primary Antibodies by alphabetical listing HOME Glypican-3 (1G12) Part Number Type Control Localisation Quantity Isotype <PREV 760-4442 05973864001 Mouse Monoclonal Hepatocellular Carcinoma Cytoplasmic 50 tests IgG1 Hepatocellular carcinoma Description Glypican-3 (GPC3) is a glycosylphosphatidyl inositol-anchored membrane protein, which may also be found in a secreted form. Recently, GPC3 was identified as a useful tumour marker for the diagnosis of HCC (hepatocellular carcinoma), hepatoblastoma, melanoma, testicular germ cell tumours and Wilms tumour. In patients with HCC, GPC3 was overexpressed in neoplastic liver tissue and elevated in serum, but was undetectable in normal liver, benign liver and the serum of healthy donors. GPC3 expression was also found to be higher in HCC liver tissue than in cirrhotic liver or liver with focal lesions such as dysplastic nodules and areas of hepatic adenoma (HA) with malignant transformation. In the context of testicular germ cell tumours, GPC3 expression is up-regulated in certain histologic subtypes, specifically yolk sac tumours and choriocarcinoma. A high level of GPC3 expression has also been found in some types of embryonal tumours, such as Wilms’ tumour and hepatoblastoma, with a low or undetectable expression in normal adjacent tissue. References 1. Capurro M, et al., Gastroenterology. 125(1):89-97, 2003. 2. Coston WMP, et al., Am J Surg Pathol. 32(3):433-444, 2008. 3. Kandil D, et al., Cancer. 111(5):316-22, 2007. Glypican 3 NEW (GC33) Part Number Type Control Localisation Quantity Isotype 4. Kakar S, et al., Arch Pathol Lab Med. 131(11):1648-54, 2007. Review. 5. Libbrecht L, et al., Am J Surg Pathol. 30(11):1405-11, 2006. 790-4564 06483186001 Mouse Monoclonal Placenta, Hepatocellular Carcinoma Granular Cytoplasmic/Membrane 50 tests IgG2a Hepatocellular carcinoma Description Glypican 3 (GC33) Mouse Monoclonal Primary Antibody is directed against the heparin sulphate proteoglycan, glypican 3. This antibody may be used to aid in the differentiation of hepatocellular carcinoma from normal liver or benign lesions. References 1. Akutsu, N, et al. World J Gastroenterol. 16,28;3521-3528, 2010. 2. Ishiguro, T, et al. Cancer Res. 68,23;9832-9838, 2008. 3. Capurro MI, et al. Cancer Res. 65;6245-6254, 2005. 4. Midorikawa Y, et al. Int J Cancer. 103;455-465, 2003. 5. Stigliano I, et al. Breast Cancer Res Treat. 114;251-262, 2009. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 124 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME Granzyme B (polyclonal) Part Number Type Control Localisation Quantity <PREV NEXT> 760-4283 05269466001 Rabbit Polyclonal Tonsil Granular Cytoplasmic, Cytotoxic T-Lymphocytes, Natural Killer Cells 50 tests Tonsil Description Granzymes are serine proteases which are stored in specialised lytic granules of cytotoxic T-lymphocytes and in natural killer cells. Granzyme B Rabbit Polyclonal Primary Antibody has been useful in diagnosing natural killer/T-cell lymphoma as well as anaplastic large cell lymphoma. High percentages of cytotoxic T cells have been shown to be an unfavourable prognostic indicator in Hodgkin’s disease. References 1. Oudejans JJ, et al., Blood. 89(4):1376-82, 197. 2. Oudejans JJ, et al., Am J Pathol. 148(1):233-40, 1996. 3. Liu J, et al., J Dermatol. 30(10):735-41, 2003. 4. Kato N, et al., Am J Dermatopathol. 25(2):142-7, 2003. 5. Kummer JA, et al., Clin Exp Immunol. 100:164-172, 1995. Helicobacter pylori, CONFIRM (polyclonal) Part Number Type Control Localisation Quantity 790-4374 05926092001 (50 tests); 790-1009 05926084001 (250 tests) Rabbit Monoclonal Infected Stomach Mucosa Cell Wall of H. pylori 50 tests and 250 tests Gastric mucosa, H. pylori Description CONFIRM Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody is designed to qualitatively detect the presence of Helicobacter pylori in gastric biopsy tissue. Immunohistochemical staining with this antibody may aid in the diagnosis of Helicobacter pylori infection. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 125 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV HER-2/neu, PATHWAY fda approved (4B5) Part Number Type Control Localisation Quantity 790-2991 05278368001 Rabbit Monoclonal Breast Carcinoma Membranous 50 tests Breast carcinoma Description This antibody is intended for in vitro diagnostic use. PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER-2 (4B5)) is a rabbit monoclonal antibody intended for laboratory use for the semi-quantitative detection of HER-2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue on a VENTANA automated immunohistochemistry slide staining device. It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin treatment is considered. Note: All of the patients in the Herceptin clinical trials were selected using a clinical trial assay. None of the patients in those trials were selected using PATHWAY anti-HER-2/neu (4B5). PATHWAY antiHER-2/neu (4B5) was compared to PATHWAY HER-2 (clone CB11) Primary Antibody on an independent sample set and found to provide acceptably concordant results. The actual correlation of PATHWAY anti-HER-2/neu (4B5) to clinical outcome has not been established. PATHWAY anti-HER-2/neu is a rabbit monoclonal antibody (clone 4B5) directed against the internal domain of the c erbB 2 oncoprotein (HER2). c erbB 2 oncoprotein was cloned and characterised by Akiyama et al in 1986.1 It is an approximately 185 kD transmembrane glycoprotein which is structurally similar to epidermal growth factor receptor (EGFR). The protein is associated with tyrosine kinase activity similar to that of several growth factor receptors and to that of the transforming proteins of the src family. The coding sequence is consistent with an extracellular binding domain and an intracellular kinase domain. This suggests that HER-2 may be involved in signal transduction and stimulation of mitogenic activity.1 Clone 4B5 has been shown to react with a 185 kD protein from SK BR 3 cell lysates via Western blotting. SK BR 3 is a breast carcinoma cell line which has a 128 fold overexpression of HER-2 mRNA.2 The size of the band identified correlates well with that reported by Akiyama et al for HER-2 protein (185 kD).1 Immunohistochemistry has been used to detect specific antigens in cells or tissue since 1950.3 The use of enzymes and peroxidase as markers for immunohistochemistry was reported by Nakane and Pierce in 1967.4 The increased sensitivity of the avidin biotin peroxidase detection system over the enzyme labelled antibody method was documented by Hsu et al in 1981.5 The HER-2 protein is expressed at a level detectable by immunohistochemistry in up to 20 percent of adenocarcinomas from various sites. Between 15 and 30 percent of invasive ductal cancers are positive for HER-2.6 Almost all cases of Paget’s disease of breast7 and up to 90 percent of cases of ductal carcinoma in situ of comedo type are positive.6 The immunohistochemical detection of HER-2 protein overexpression is also used as an aid in determination of patients for whom Herceptin therapy is indicated.8 Staining results in normal tissues, neoplastic tissues and 322 cases of breast carcinoma with PATHWAY HER-2 (4B5) were evaluated by Ventana Medical Systems, Inc. In the normal tissues tested, expression was consistent with the published litreature in that there was no unexpected specific cytoplasmic/membrane staining, with the following exceptions: two cases of tonsil showing with epithelial cell membrane staining, one case of parathyroid and one case of oesophageal epithelium. Of the neoplastic tissues tested, cytoplasmic/membrane staining was seen in cancer cells of the breast, colon and ovary. Three hundred twenty-two (322) breast carcinomas were evaluated with PATHWAY HER-2 (4B5) in a method comparison study with PATHWAY HER-2 (CB11). There is a significant correlation of staining between these two tests. See Summary of Expected Results section for further information. PATHWAY HER-2 (4B5) in combination with iVIEW DAB Detection Kit, utilises biotinylated secondary antibodies to locate the bound PATHWAY HER-2 (4B5) primary antibody (produced by using a synthetic peptide corresponding to a site on the internal domain of the HER-2 protein). This is followed by the binding of an avidin/streptavidin enzyme conjugate to the biotin. The complex is then visualised using a precipitating enzyme generated product. The use of pre-diluted PATHWAY HER-2 (4B5) and ready to use iVIEW DAB detection kits, in combination with a VENTANA automated slide stainer, reduces the possibility of human error and inherent variability resulting from individual reagent dilution, manual pipetting and manual reagent application. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 126 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> Clinical Significance Breast cancer is the most common carcinoma occurring in women and the second leading cause of cancer-related death. In North America, a woman’s chance of contracting breast cancer is one in eight.9 Early detection and appropriate treatment therapies can significantly affect overall survival.10 Small tissue samples may be easily used in routine immunohistochemistry (IHC), making this technique, in combination with antibodies that detect antigens important for carcinoma interpretation, an effective tool for the pathologist in his/her diagnosis and prognosis of disease. One important marker in breast cancer today is cerbB 2 oncoprotein (HER-2). HER-2 is an intracellular membrane protein detected in the cellular membrane.11 It is closely related to EGFR and, like EGFR, has tyrosine kinase activity.1 Gene amplification and the corresponding overexpression of cerbB 2 has been found in a variety of tumours, including breast carcinomas.11,12 The therapeutic drug Herceptin has been shown to benefit some breast carcinoma patients by arresting and in some cases reversing the growth of their cancer.8 The drug is a humanised monoclonal antibody that binds to HER-2 protein on cancer cells. Thus only patients with HER-2/neu positive breast carcinomas should benefit from treatment with Herceptin. In vitro diagnostics for the determination of HER-2 status in breast carcinomas are important to aid the clinician in determination of therapy with Herceptin. Interpretation of the results of any detection system for HER-2 must take into consideration the fact that HER-2 is expressed in both breast cancer tumours and healthy tissue, albeit at differing levels and with different patterns of expression.13 Histological tissue preparations have the advantage of intact tissue morphology to aid in the interpretation of the HER2 positivity of the sample. All histological tests should be interpreted by a specialist in breast cancer morphology and/or pathology and the results should be complemented by morphological studies and proper controls and used in conjunction with other clinical and laboratory data. References 1.Akiyama T, et al., Science 232: 1644-1646, 1986. 2. Kraus MH, et al., EMBO. 6: 605-610, 1987. 3. Coons AH, et al., J. Exp. Med. 91: 1-13, 1950. 4. Nakane PK, et al., J. Histochem. Cytochem. 14:929-931, 1967. 5. Hsu SM, et al., J. Histochem. Cytochem. 29:577-580, 1981. 6. Dickson RB, Lippman, ME, Genes, Oncogenes and Hormones. Boston, Kluwer Academic Publishers, 1992. 7. Keatings L, et al., Histopathology. 17:234-247, 1990. 8. Herceptin (Trastuzamab) Package Insert. February 2005. 9. Roche PC, Immunohistochemical stains for breast cancer. Mayo Clin. Proc. 69:57-58, 1994. 10. Charpin C, et al., Br. J. Cancer. 75: 1667-1673, 1997. 11. Corbett IP, et al., J. Pathol. 161:15-25, 1990. 12. Nicholson RI, et al., Eur. J. Cancer. 29A:1018-1023, 1993. 13. DePotter CR, et al., Histopathology. 15:351-362, 1989. Criteria for Intensity of Cell Membrane Staining with PATHWAY HER-2/neu Staining Pattern Score (report to physician) HER-2 Staining Assessment No membrane staining is observed 0 Negative Faint, partial staining in > 10% of cancer cells with rare or absent circumferential staining 1+ Negative Weak circumferential membrane staining in > 10% of cancer cells but the membrane staining ring is thin 2+ Positive Intense circumferential membrane staining in > 10% of cancer cells and the membrane staining ring is thick 3+ Positive 1+ Membrane Staining 2+ Membrane Staining 3+ Membrane Staining Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 127 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV HER2/neu, VENTANA NEW (4B5) Part Number Type Control Localisation Quantity 790-4493 05999570001 Rabbit Monoclonal Breast Carcinoma Membranous 50 tests Description VENTANA HER2/neu (4B5) Rabbit Monoclonal Primary Antibody (VENTANA HER2 - 4B5) is intended for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic breast and gastric tissue on a VENTANA automated slide staining device. VENTANA HER2 (4B5) is a rabbit monoclonal antibody directed against the internal domain of the c-erbB-2 oncoprotein (HER2). In breast carcinoma, the HER2 protein is expressed at a level detectable by immunohistochemistry in up to 20% of adenocarcinomas from various sites. Overexpression of the HER2 protein, amplification of the HER2 gene or both occur in approximately 15 to 25 percent of breast cancers and are associated with aggressive tumour behaviour.1 Almost all cases of Paget’s disease of breast 2 and up to 90 percent of cases of ductal carcinoma in situ of comedo type are positive. 3 In gastric carcinoma the HER2 protein is expressed at a level detectable by immunohistochemistry in up to 30 percent of intestinal type, 15 percent mixed type and 5 percent diffuse type gastric cancers.4 References 1. Slamon DJ, et al., Human breast cancer: correlation of relapse and survival with amplification of the HER2/neu oncogene. Science 1987;235:177-182 2. Keatings L, et al., cerbB-2 oncoprotein expression in mammary and extramammary Paget’s desease: an immunohistochemical study. Histopathology. 17: 234-247, 1990 3. DIckson RB, Lippman ME, Genes, Oncogenes and Hormones. Boston: Kluwer Academic Publishers, 1992 4. Herceptin (Trastuzamab) Package Insert. Accessed October 2010 Herpes Simplex Virus I (HSV I) (polyclonal) Part Number Type Control Localisation Quantity 760-4261 05269237001 Rabbit Polyclonal Infected Tissue Cytoplasmic, Nuclear 50 tests Description Herpes Simplex virus is quite ubiquitous and is quite variable in its presentation in human disease. Type I usually infects the non-genital mucosal surfaces. It may affect the skin or internal organs (typically brain, lung, liver, adrenal gland or GI tract) of immunocompromised individuals. HSV I Rabbit Polyclonal Primary Antibody reacts with Type I Herpes viruses. There may be cross-reactivity with Varicella Zoster virus at higher concentration. Cross-reactivity with the CMV or Epstein-Barr virus is not seen with this antibody, Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 128 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> Herpes Simplex Virus II (HSV II) (polyclonal) Part Number Type Control Localisation Quantity 760-4262 05269245001 Rabbit Polyclonal Infected Tissue Cytoplasmic, Nuclear 50 tests Follicular lymphoma Description Herpes Simplex virus is quite ubiquitous and is quite variable in its presentation in human disease. Type II typically involves the genitalia. It may affect the skin or internal organs (typically brain, lung, liver, adrenal gland or GI tract) of immunocompromised individuals. HSV II Rabbit Polyclonal Primary Antibody reacts with Type II Herpes viruses. There may be cross-reactivity with Varicella Zoster virus at higher concentration. Cross-reactivity with CMV or EBV is not seen with this antibody, HGAL NEW (MRQ-49) Part Number Type Control Localisation Quantity Isotype 760-4597 06433375001 Mouse Monoclonal Tonsil, Lymph Node Cytoplasmic 50 tests IgG2a/K Follicular lymphoma Description HGAL (MRQ-49) Mouse Monoclonal Primary Antibody used as an aid in the identification of follicular lymphoma within the context of an antibody panel, the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist. References 1. Natkunam, Y et al. Blood. 105:3979–3986, 2005. 2. Natkunam, Y et al. Blood. 109:298-305, 2007. 3. Younes, SF et al. Am J Surg Pathol. 34:1266-1276, 2010. 4. Higgins, RA et al. Arch Pathol Lab Med. 132:441-446, 2008. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 129 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV HHV-8 (Human Herpes Virus Type 8) (13B10) Part Number Type Control Localisation Quantity Isotype 760-4260 05269229001 Mouse Monoclonal Kaposi’s Sarcoma Nuclear 50 tests IgG1 Kaposi’s sarcoma Description Human herpes virus type 8 (HHV-8) is the likely etiological agent of Kaposi’s sarcoma (KS). HHV-8 DNA sequences have been found in Kaposi’s sarcoma lesions, primary effusion lymphoma and multicentric Castleman’s disease via polymerase chain reaction and in situ hybridisation. Latent nuclear antigen (LNA-1, LNA, LANA-1), also known as ORF73, is a 222- or 234 kD protein that is consistently expressed in HHV-8 infected cells. HHV-8 (13B10) Mouse Monoclonal Primary Antibody labels the latent nuclear antigen protein via immunohistochemistry. References 1. Corbellino M, et al., AIDS Res Hum Retroviruses. 12(8):651-7, 1996. 2. Katano H, et al., Am J Pathol. 155(1):47-52, 1999. 3. Katano H, et al., J Med Virol. 59(3):346-55, 1999. 4. Katano H, et al., Mod Pathol. 13(1):77-85, 2000. 5. Kaaya E, et al., Med Oncol. 17(4):325-32, 2000. HSA (Hepatocyte Specific Antigen) (0CH1E5) Part Number Type Control Localisation Quantity Isotype 760-4350 05269792001 Mouse Monoclonal Liver Cytomplasmic 50 tests IgG1/K Liver Description Hepatocyte Specific Antigen (OCH1E5) Mouse Monoclonal Primary Antibody recognises both benign and malignant liver including such tumours as hepatoblastoma, hepatocellular carcinoma and hepatic adenoma. It recognises both normal adult and foetal liver tissue. The typical pattern is a granular cytoplasmic staining. This antibody is useful in differentiating hepatocellular carcinomas with adenoid features from adenocarcinomas, either primary in the liver or metastatic lesions to the liver. In recognising hepatoblastoma, it is useful in differentiating this entity from other small round cell tumours. References 1. Minervini MI, et al., Mod Pathol. 10(7):686-692, 1997. 2. Fasano M, et al., Mod Pathol. 11(10):934-938, 1998. 3. Tsui WMS, et al., Am J Surg Pathol. 23(1): 34-48, 1999.. 4. Wieczorek T, et al., Am J Clin Pathol. 118(6):911-21, 2002. 5. Chu PG, et al., Am J Surg Pathol. 26(8):978-88, 2002. 6. Maitra A, et al., Am J Clin Pathol. 115(5):689-94, 2001. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 130 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> Human Chorionic Gonadotropin (hCG) (polyclonal) Part Number Type Control Localisation Quantity 760-2650 05267617001 Rabbit Polyclonal Placenta Cytoplasmic 50 tests Placenta, cytotrophoblasts Description Human chorionic gonadotropin (hCG) is a protein secreted in large quantities by normal trophoblasts. Human Chorionic Gonadotropin Rabbit Polyclonal Primary Antibody detects cells and tumours of trophoblastic origin such as choriocarcinoma. Large cell carcinoma and adenocarcinoma of the lung demonstrate hCG positivity in 90% and 60% of cases respectively. 20% of squamous cell lung carcinomas are positive for hCG. hCG expression by non-trophoblastic tumours may indicate aggressive behaviour since it has been observed that hCG may play a role in the host response to a given tumour. References 1. Morrish DW, et al., J Histochem Cytochem. 35:39-101, 1987. 2. Kurman RJ, et al., Cancer. 38:2404-2419, 1976. 3. Kurman RJ, et al., Int J Gyn Pathol. 3:101-12, 1984 4. Boucher LD, et al. Human Pathol. 26(11):1201-6, 1995. Human Placental Lactogen (hPL) (polyclonal) Part Number Type Control Localisation Quantity Isotype 760-4443 05973830001 Rabbit Polyclonal Placenta Cytoplasmic 50 tests IgG Placenta, normal Description Human placental lactogen (hPL), also previously known as human chorionic somatomammotropin, is a 22 kD protein with partial homology to growth hormone. hPL is first detectable in the maternal serum in the fifth week of gestation and reaches a plateau by the thirtyfourth week. hPL has been demonstrated by immunochemistry in the syncytiotrophoblastic cells of choriocarcinoma. A rare variant of trophoblastic tumour has been reported in the testis with resemblance to uterine placental site trophoblastic tumour. It consisted purely of intermediate trophoblasts, which was diffusely positive for hPL and focally for B-hCG. References 1. Shih IM, et al., Am J Surg Pathol. 28(9):1177-83, 2004. 2. Ulbright TM, et al., Am J Surg Pathol. 21(3):282-288, 1997. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 131 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV IgA (Immunoglobulin A) (polyclonal) Part Number Type Control Localisation Quantity 760-2652 05267625001 Rabbit Polyclonal Tonsil, Lymph Node Cytoplasmic 50 tests Tonsil, germinal centre Description IgA Rabbit Polyclonal Primay Antibody reacts with surface immunoglobulin IgA alpha chains. It is useful when identifying leukaemias, plasmacytomas and B-cell lineage derived Hodgkin’s lymphomas. Due to the restricted expression of heavy and light chains in these diseases, demonstration of B-cell lymphomas is possible with clonal gene rearrangement studies. References 1. Arnold A, et al., New Eng J Med. 309:1593-1599, 1983. 2. Geenwich Medical Media Ltd. 217-219, 1999. 3. Hertel BF, et al., New Eng J Med. 302:1293-1297, 1980. 4. Taylor CR, et al., Arch Path Lab Med. 102:113-121, 1978. 5. Warnake R, et al., Masson Publishing USA. 203-221, 1981. IgD (Immunoglobulin D) (polyclonal) Part Number Type Control Localisation Quantity Isotype 760-4444 05973821001 Rabbit Polyclonal Lymph Node, Tonsil Cytoplasmic 50 tests IgG Tonsillitis, sub-epithelial plasma cells Description IgD Rabbit Polyclonal Primay Antibody reacts with surface immunoglobulin IgD delta chains. This antibody is useful when identifying leukaemias, plasmacytomas and B-cell lineage derived lymphomas (in particular marginal zone lymphoma). Cytoplasmic staining is easily identified on paraffin tissue. Surface immunoglobulin is difficult to demonstrate on paraffin sections but can be demonstrated on frozen sections. References 1. Campo E, et al., Am J Surg Pathol. 23(1):59-68, 1999. 2. Mori S, et al., Acta Pathol Jpn. 36(1):1429-40, 1986. 3. Oka K, et al., Acta Haematol. 90(2):84-9, 1993. 4. Bertero M, et al., J Am Acad Dermatol. 30(1):23-30, 1994. 5. Mollego M, et al., Am J Surg Pathol. 21(7):772-80, 1997. 6. Tang X, et al., Pathol Int. 45(1):34-44, 1995. 7. Gupta D, et al., Mod Pathol. 13(11):1161-6, 2000. 8. Anagnostopoulos I, et al., Histopathology. 39(6):561-5, 2001. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 132 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> IgG (Immunoglobulin G) (polyclonal) Part Number Type Control Localisation Quantity 760-2653 05267633001 Rabbit Polyclonal Tonsil, Lymph Node Cytoplasmic 50 tests Tonsil, germinal centre Description IgG Rabbit Polyclonal Primay Antibody reacts with surface immunoglobulin IgG gamma chains. This antibody is useful when identifying leukaemias, plasmacytomas and B-cell lineage derived Hodgkin’s lymphomas. Due to the restricted expression of heavy and light chains in these diseases, demonstration of B-cell lymphomas is possible with clonal gene rearrangement studies. References 1. Arnold A, et al., New Eng J Med. 309:1593-1599, 1983. 2. Geenwich Medical Media Ltd. 217-219, 1999. 3. Hertel BF, et al., New Eng J Med. 302:1293-1297, 1980. 4. Taylor CR, et al., Arch Path Lab Med. 102:113-121, 1978. 5. Warnake R, et al., Masson Publishing USA. 203-221, 1981. IgM (Immunoglobulin M) (polyclonal) Part Number Type Control Localisation Quantity 760-2654 05267641001 Rabbit Polyclonal Tonsil, Lymph Node Cytoplasmic 50 tests Tonsil, germinal centre Description IgM Rabbit Polyclonal Primay Antibody reacts with surface immunoglobulin IgM mu chains. IgM is one of the predominant surface immunoglobulins on B lymphocytes. This antibody is useful when identifying lymphomas, plasmacytomas and B-cell lineage derived Hodgkin’s lymphomas. Due to the restricted expression of heavy and light chains in these diseases, demonstration of B-cell lymphomas is possible with clonal gene rearrangement studies. References 1. Arnold A, et al., New Eng J Med. 309:1593-1599, 1983. 2. Geenwich Medical Media Ltd. 217-219, 1999. 3. Hertel BF, et al., New Eng J Med. 302:1293-1297, 1980. 4. Taylor CR, et al., Arch Path Lab Med. 102:113-121, 1978. 5. Warnake R, et al., Masson Publishing, USA. 203-221, 1981. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 133 IHC & ISH | Primary Antibodies by alphabetical listing HOME Inhibin, alpha (R1) Part Number Type Control Localisation Quantity Isotype <PREV 760-2834 05268311001 Mouse Monoclonal Adrenal Cortex, Placenta, Testis Cytoplasmic 50 tests IgG2a Placenta Description Inhibin alpha (R1) Mouse Monoclonal Primary Antibody is an antibody against a peptide hormone which has demonstrated utility in the differentiation between adrenal cortical tumours and renal cell carcinoma. Sex cord stromal tumours of the ovary as well as trophoblastc tumours also demonstrate cytoplasmic positivity with this antibody. References 1. Arora DS, et al., J Pathol. 181(4):413-8, 1997. 2. Stewart CJ, et al., Histopathology. 31(1):67-74, 1997. 3. Yamashita K, et al., Am J Obstet Gynecol. 177(6):1450-7, 1997. Insulin (polyclonal) Part Number Type Control Localisation Quantity 4. McCluggage WG, et al., Am J Surg Pathol. 22(5):615-9, 1998. 5. Kommoss F, et al., Mod Pathol. 11(7):656-64, 1998. 6. Matias-Guiu X, et al., Hum Pathol. 29(8):840-5, 1998. 760-2655 05267650001 Rabbit Polyclonal Pancreas Cytoplasmic 50 tests Pancreas, islets of Langerhans Description Insulin is produced in the beta cells of the pancreas. The presence of insulin in the cytoplasm of islet tumours is the most reliable indication of functional insulinomas. Defective insulin storage occurs in insulinomas, therefore, many sections of the tumour should be stained with both insulin and C peptide. References 1. Akagi T, et al., Cancer. 47:417-424, 1981. 2. Scully RE, et al., N Eng J Med. 308:30-37, 1983. 3. Erlandsen SL, et al., Williams and Wilkins, Baltimore. 140-155, 1980. 4. Friesen SR, et al., N Eng J Med. 306:580-590, 1982. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 134 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> Insulin Growth Factor-1 Receptor (IGF-1R), CONFIRM (G11) Part Number Type Control Localisation Quantity 790-4346 05278449001 Rabbit Monoclonal Breast Carcinoma, Placenta Membranous 50 tests Breast carcinoma Description CONFIRM IGF-1R (G11) Rabbit Monoclonal Primary Antibody is produced against a synthetic peptide from the internal domain of the beta chain receptor near the carboxy terminal region and binds to the IGF-1R epitope. IGF-1R is a type 2 tyrosine kinase receptor that shares a 60% homology at the amino acid sequence level with Insulin Receptor (IR). References 1. Samani A, et al., Endocrine Reviews, 28(1):20-47, 2007. Kappa, CONFIRM (polyclonal) Part Number Type Control Localisation Quantity 760-2514 05267013001 Rabbit Polyclonal Tonsil, Lymph Node Surface Membrane and/or Cytoplasmic 50 tests Tonsil, germinal centre Description CONFIRM Kappa Rabbit Polyclonal Primary Antibody specifically binds to antigens located in the cell membrane and cytoplasmic regions of normal B cells and plasma cells. Kappa light chains are polypeptide chains which in combination with heavy chains form immunoglobulin molecules. There are two classes of light chains found in immunoglobulins, kappa light chains and lambda light chains. Light chain production by lymphoid cells is genetically restricted such that the immunoglobulin molecules produced by an individual cell will only contain a single light chain class. This clonal restriction may be used to indicate the polyclonal or monoclonal nature of B cell and plasma cell populations. Because clonality is a clinically important attribute to aid in the subclassification of lymphomas, the identification of light chain class has gained increasing importance in immunopathology. References 1. Landaas TO, et al., Acta Path Microbiol Scand. 89(2):91-101, 1981. 2. Pangalis GA, et al., Cancer. 45(6):1334-1339, 1980. 3. Woda BA, et al., Cancer. 43(1):303-307, 1979. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 135 IHC & ISH | Primary Antibodies by alphabetical listing HOME Ki-67, CONFIRM (30-9) Part Number Type Control Localisation Quantity <PREV 790-4286 05278384001 Rabbit Monoclonal Lymph Node, Tonsil Nuclear 50 tests Description CONFIRM Ki-67 (30-9) Rabbit Monoclonal Primary Antibody is directed against C-terminal portion of Ki-67 antigen. Staining for Ki-67 can aid in assessing the proliferative activity of normal and neoplastic tissue. This antibody is intended for use to identify stained proliferating cells. Ki-67 is a nuclear protein expressed in proliferating cells. During the cell cycle, the Ki-67 antigen is present in the G1, S, G2 and M phase, but is absent in the G0 (quiescent) phase. References 1. Keng PC, et al., Radiat Oncol Investig. 6(3):120-7, 1998. 2. Rey A, et al., Arch Esp Urol. 51(2): 204-10, 1998. 3. Bacchi CE, et al., Braz J Med Biol Res. 26(7):677-87, 1993. Ksp-Cadherin (MRQ-33) Part Number Type Control Localisation Quantity Isotype 4. Alliegro M, et al., Exp Cell Res. 279(1):111-17, 2002. 5. Scholzen T, et al., J Cell Physiol. 182(3):311-22, 2000. 760-4387 05463548001 Mouse Monoclonal Kidney, Chromophobe Renal Cell Carcinoma Cytoplasmic, Membranous 50 tests IgG1 Kidney Description Kidney-specific cadherin (KSP-Cadherin) is a novel, kidney-specific member of the cadherin family of cell adhesion molecules. Within the kidney, KSP-Cadherin is found exclusively in the basolateral membrane of renal tubular epithelial cells and collecting duct cells, and not in glomeruli, renal interstitial cells or blood vessels. Different cadherins, including E-cadherin, cadherin-6 and N-cadherin, have been investigated in renal cell cancers, demonstrating possible correlations of tumour dedifferentiation and the presence of lymph node metastasis with loss of cadherins. Mazal, et al. investigated the utility of using KSP-Cadherin to distinguish chromophobe renal cell carcinoma from oncocytoma. He found a membranous pattern of staining in 96% of 30 chromophobe carcinomas and in only 6% of 31 oncocytomas leading them to conclude that this is a useful antibody in differentiating these two lesions. Shen, et al., on the other hand, found KSP-Cadherin positivity in 100% of 13 chromophobe RCCs and 95% of 20 oncocytomas. References 1. Mazal PR, et al., Hum Pathol. 36(1):22-8, 2005. 2. Shen SS, et al., Mod Pathol. 18(7):933-40, 2005. 3. Thedieck C, et al., Br J Cancer. 92(11):2010-7, 2005. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 136 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME Lambda, CONFIRM (polyclonal) Part Number Type Control Localisation Quantity <PREV NEXT> 760-2515 05267021001 Rabbit Polyclonal Tonsil Surface Membrane and/or Cytoplasmic 50 tests Tonsil, germinal centre Description CONFIRM Lambda Rabbit Polyclonal Primary Antibody specifically binds to antigens located in the cell membrane and cytoplasmic regions of normal B cells and plasma cells. Lambda light chains are polypeptide chains which in combination with heavy chains form immunoglobulin molecules. There are two classes of light chains found in immunoglobulins, kappa light chains and lambda light chains. Light chain production by lymphoid cells is genetically restricted such that the immunoglobulin molecules produced by an individual cell will only contain a single light chain class. This clonal restriction may be used to indicate the polyclonal or monoclonal nature of B cell and plasma cell populations. Because clonality is a clinically important attribute to aid in the subclassification of lymphomas, the identification of light chain class has gained increasing importance in immunopathology. References 1. Landaas TO, et al., Acta Path Microbiol Scand. 89(2):91-101, 1981. 2. Pangalis GA, et al., Cancer. 45(6):1334-1339, 1980. LMO2 , CONFIRM (1A9-1) Part Number Type Control Localisation Quantity Isotype 3. Woda BA, et al., Cancer. 43(1):303-307, 1979. 790-4368 05479274001 Mouse Monoclonal Tonsil, Lymph Node Nuclear 50 tests IgG1/K Normal tonsil Description CONFIRM LMO2 (1A9-1) Mouse Monoclonal Primary Antibody (IgG1) is directed against a 24 kD protein in the LIM only family. LMO2 is expressed in normal germinal centre (GC) B cells and in a subset of GC derived B-cell lymphomas and normal hematopoietic lineages. LMO2 is essential for the regulation of hematopoietic stem cells and is expressed in erythroid and myeloid precursors playing a crucial role in hematopoietic development. Preliminary studies demonstrate LMO2 expression in GC-derived B-cell lymphomas such as follicular, Burkitt, lymphocyte-predominant Hodgkin’s and diffuse large B-cell (DLBCL) neoplasms. LMO2 staining was absent in mature B-cell and T-cell lymphomas and in classical Hodgkin’s lymphomas. References 1. Natkunam Y, et al., Blood. 109:1636-1642, 2007. 2. Lossos I, et al., N Engl J Med. 350:1828-1837, 2004. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 137 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV Luteinizing Hormone (LH) (polyclonal) Part Number Type Control Localisation Quantity 760-2802 05268222001 Rabbit Polyclonal Normal Pituitary Cytoplasmic 50 tests Pituitary Description Luteinizing Hormone (LH) Rabbit Polyclonal Primary Antibody is a useful marker in classification of pituitary tumours and the study of pituitary disease. It reacts with LH-producing cells (gonadotrophs). References 1. La Rosa S, et al., Virchows Arch. 437(3):264-9, 2000. 2. Saccomanno K, et al., J Clin Endocrinol Metab. 78(5):1103-7, 1994. 3. Kovalitc JJ, J Neurooncol. 16(3):227-32, 1993. Lysozyme (polyclonal) Part Number Type Control Localisation Quantity 4. Felix I, et al., Hum Pathol. 22(7):179-21, 1991. 5. Sano T et al. Virchows Arch A Pathol Anat Histopathol. 1990;417(4):361-7. 760-2656 05267668001 Rabbit Polyclonal Tonsil, Lymph Node Cytoplasmic 50 tests Tonsil Description Lysozyme Rabbit Polyclonal Primary Antibody stains myeloid cells, histiocytes, granulocytes, macrophages and monocytes in human tonsil, colon and skin. It is an important marker that may demonstrate the myeloid or monocytic nature of acute leukaemia. The restrictive nature of Lysozyme antibody staining suggests that lysozyme may be synthesised predominantly in reactive histiocytes rather than in resting, unstimulated phagocytes. It has not been determined whether lysozyme stains any other cell or tissue type. Lysozyme antibody may aid in the identification of histiocytic neoplasias, large lymphocytes and classifying lymphoproliferative disorders. References 1. Morsky P, et al., Clin Chim Acta. 178:327-36, 1988. 2. Krugliak L, et al., Am J Hematol. 21:99-109, 1986. 3. Delaflor-Weiss E, et al., Acta Cytol. 43(6):1124-30, 1999. 4. Yuen ST, et al., Histopathology. 32(2):126-32, 1998. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 138 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME Macrophage (HAM-56) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-2657 05267676001 Mouse Monoclonal Tonsil, Lymph Node Cytoplasmic 50 tests IgM/K Tonsil, macrophages Description Macrophage (HAM-56) Mouse Monoclonal Primary Antibody reacts with tingible macrophages, interdigitating macrophages of lymph nodes and tissue macrophages, e.g. Kupffer cells of the liver and alveolar macrophages of the lung. The antibody also stains a subpopulation of endothelial cells, most prominently those of the capillaries and smaller blood vessels. Macrophage antibody reacts with monocytes, but is unreactive with B- and T-lymphocytes. References 1. Gown AM, et al., Am J Pathol. 125:191-207, 1986. 2. Alpers CE, et al., Am J Clin Pathol. 92:662-665, 1989. Mammaglobin (31A5) Part Number Type Control Localisation Quantity Isotype 3. Bosman C, et al., J Pediatr Hematol Oncol. 21(1):31-7, 1999. 4. Soini Y, et al., Pathol Res Pract. 186(6):759-67, 1990. 760-4263 05269253001 Rabbit Monoclonal Breast Carcinoma Cytoplasmic 50 tests IgM/K Breast carcinoma Description Mammaglobin (10 kD) is a breast-associated glycoprotein distantly related to secretoglobin family that includes human uteroglobin and lipophilin. Mammaglobin mRNA is present in high levels in human breast cancer cell lines, which has been shown to be a sensitive marker of breast cancer. When combined with other breast-restricted markers such as GCDFP-15, an overall sensitivity for breast carcinoma of 84% has been achieved. Mammaglobin antibody can also be used to determine breast origin in the setting of metastatic carcinoma. References 1. Watson MA, et al., Cancer Research. 59:3028-3031, 1999. 2. Fleming TP, et al., Ann N Y Acad Sci. 923:78- 89, 2000. 3. Han JH, et al., Arch Pathol Lab Med. 127:1330-1334, 2003. 4. Bhargava R, et al., Am J Clin Pathol. 127(1):103-13, 2007. 5. Sasak E, et al., Breast Mod Pathol. 20 (2):208-14. 2007. 6. Wang Z, et al., Int J Clin Exp Pathol. 2(4):384-9, 2009. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 139 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV MART-1/melan A, CONFIRM (A103) Part Number Type Control Localisation Quantity Isotype 790-2990 05278350001 Mouse Monoclonal Normal Skin, Melanoma Cytoplasmic 50 tests IgG1 Melanoma Description Melanoma is a malignant tumour deriving from melanocytes. Melanocytes are derivative cells originating from the neuroectodermal crest, which migrate during the early foetal period into the skin, where they settle within the epidermis and become part of the complex skin structure. One of the most prominent functional features of melanocytes is to produce the melanin pigment as a response to UV radiation in order to protect the skin structures from sun damage. Approximately 47,700 cases per year are diagnosed in the United States alone and the incidence is increasing at the rate of 4.3% per year. In about 2% of occurrences, the disease is present even though no skin discolouration occurs. The American Cancer Society estimates that there are currently 480,000 cases of melanoma in America today and that there are 7,700 deaths per year. It has been reported that in the US, Europe and Australia there are 90,000 new cases diagnosed per year and 15,000 deaths annually. To aid in the diagnosis of these potentially lethal lesions, monoclonal antibodies have been raised against an antigenic determinate localised to a glycoprotein that is restricted to cells of melanocytic lineage. The molecule is located in the inner membranes of type 1, 2 and 3 pre-melanosomes and serves as a potential target of cytotoxic T-lymphocytes, probably in concert with MHC2A. MART-1/melan A, was named specifically for that property (melanoma antigen recognised by T cells-1) and is recognised by T cells. In practice, HMB-45 and MART-1/melan A have enjoyed the greatest use as agents to confirm the identity of polyclonal S100 positive neoplasms as melanocytic in nature. MART-1/melan A and HMB-45 behave differently depending on the tissue fixation. MART-1/melan A is suitable for formalin-fixed tissues and archival material which requires heat-induced epitope retrieval (HIER). Both HMB-45 and MART1/melan A show increased sensitivity with HIER, though HMB-45’s immunoreactivity is stronger in ethanol-fixed tissues than formalinfixed. Prolonged fixation in formalin significantly diminishes HMB-45’s immunoreactivity. HMB-45 is also vulnerable to a high degree of non-specific staining when used with Mercury-based fixatives. The two monoclonal antibodies also differ in their detection rates of melanoma. MART-1/melan A has demonstrated positive rates of 8190% versus HMB-45 at 75-80% on primary and metastatic malignant melanoma. Unlike HMB-45, MART-1/melan A is purported to yield a homogeneous cytoplasmic staining pattern in both melanomas and melanocytic nevi, with a stronger intensity and greater percentage of tumour cell immunopositivity. HMB-45 stains mainly the intraepidermal and superficial dermal component of compound nevi. MART-1/ melan A is useful for the detection of primary and metastatic melanomas, especially with an epithelioid morphology, yet it has a limited role in the differential diagnosis of desmoplastic melanomas. In a study published by AA Jungbluth, et al., additional information as to the detection rates of melanoma is as follows: of the 75 metastatic melanomas tested 81% were A-103 positive and 75% were HMB-45 positive. Of the positive cases, A-103 showed homogeneous staining in a significantly higher number of cases than HMB-45 (72% vs. 52%, respectively). Focal staining with less than 5% reactive tumour cells was seen more frequently in HMB-45 (12 of 56) than in A-103 (5 of 61). References 1. Dabbs DJ, et al., Immunohistochemistry, Churchill Livingstone, Philadelphia, 2002. 2. Leong AS-Y, et al., Diagnostic Antibodies for Immunohistology, 2nd Edition. Greenwich Medical Media Ltd., London, 2003. 3. Jungbluth AA, et al., Am J Surg Pathol. 22(5): 595-602, 1998. 4. Jungbluth AA, et al., Virchows Arch. 434:429-435, 1999. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 140 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> Melanoma Associated Antigen NEW (KBA.62) Part Number Type Control Localisation Quantity Isotype 760-4527 06419186001 Mouse Monoclonal Melanoma Cytoplasmic 50 tests IgG1 Description Melanoma Associated Antigen (KBA.62) Mouse Monoclonal Primary Antibody is a novel melanoma antibody. Studies thus far have shown a similar sensitivity to melanocytic proliferations as that seen with S-100 protein staining, which is somewhat higher than that seen with HMB-45. This has been confirmed by one study on a series of 215 sentinel lymph nodes. Moreover, KBA.62 antibody identified 6 patients (3%) who had confirmed sentinel lymph node metastasis but stained negative for HMB-45. In this setting, the resolution appears to be higher than S-100 protein in that the staining pattern (membranous) is quite distinct. References 1. Morris LG, et. al., Head Neck. 30:771-775, 2008. 2. Busam KJ, et. al., Am J Surg Pathol. 29: 400-406, 2005. 3. Rochaix P, et. al., Mod Pathol. 16:481-490, 2003. 4. Nonaka D, et. al., Am J Clin Pathol. 127:787-791, 2003. 5. Zhe X, et. al., J Histochem Cytochem. 52:1537-1542, 2004 Melanoma Associated Antigen NEW (PNL2) Part Number Type Control Localisation Quantity Isotype 760-4528 06419194001 Mouse Monoclonal Melanoma Cytoplasmic 50 tests IgG1 Description Melanoma Associated Antigen (PNL2) Mouse Monoclonal Primary Antibody is a novel monoclonal antibody, which has recently been introduced as an immunohistochemical reagent to stain melanocytes and tumours derived therefrom. PNL2 antibody yields a strong cytoplasmic staining of skin and oral mucosal melanocytes and staining of granulocytes when used at high concentration. PNL2 antibody labels intraepidermal nevi while the dermal component of compound nevi are largely non-reactive with PNL2 antibody. Antibodies against PNL2, melan-A and HMB-45 stain most clear cell sarcoma cells and a few cells in angiomyolipomas and lymphangioleiomyomatosis. Nonmelanocytic lesions found to be positive with this marker include PEComas and melanotic schwannoma. PNL2 antibody is a useful antibody for the identification of melanomas and clear cell sarcomas. References 1. Shah RB, et. al., Am J Clin Pathol. 122:517-523, 2004. 2. Morris LG, et. al., Head Neck. 30:771-5, 2008. 3. Busam KJ, et. al., Am J Surg Pathol. 29: 400-6, 2005. 4. Rochaix P, et. al., PNL2, Mod Pathol. 16:481-90, 2003. 5. Nonaka D, et. al., Am J Clin Pathol. 127:787-91, 2007. 6. Zhe X, et. al., J Histochem Cytochem. 52:1537-42, 2004. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 141 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV Melanosome, CONFIRM (HMB45) Part Number Type Control Localisation Quantity Isotype 790-4366 05479282001 Mouse Monoclonal Melanoma, Skin Cytoplasmic 50 tests IgG1/K Melanoma, with area showing normal melanoctyes Description CONFIRM Melanosome (HMB45) Mouse Monoclonal Primary Antibody has been shown to react with immature melanosomes in foetal and neonatal melanocytes and infantile retinal pigment epithelium. It does not react with normal resting adult melanocytes, regardless of the degree of pigmentation. In malignant cells, HMB45 stains most primary and metastatic melanomas. Desmoplastic malignant melanomas infrequently express the HMB45 antigen, possibly because they contain few melanosomes and have a mesenchymal pattern of differentiation. Non-melanocytic tumour cells of epithelial, lymphoreticular, glial and mesenchymal origin are not labelled except for renal angiomyolipomas (PAML), a type of mesenchymal hamartoma. References 1. Kapur R, et al., J Histochem Cytochem. 40(2):207-212, 1992. 2. Gown A, et al., Am J Pathol. 123(2):195-203, 1986. 3. Esclamado R, et al., Am J Surg. 152(4): 376-385, 1986. 4. Colombari R, et al., Virchows Archiv A Pathol Anat. 413(1):17-24, 1988. Mesothelial Cell (HBME-1) Part Number Type Control Localisation Quantity Isotype 5. Skelton H, et al., Am J Dermapathol. 13(6): 543-550, 1991. 6. Ordonez N, et al., Am J Clin Pathol. 90(4): 385-390, 1988. 7. Pea M, et al., Pathol. 23(3): 185-188, 1991. 8. Ashfaq R, et al., Cancer. 71(10): 3091-3097, 1993. 760-4445 05973813001 Mouse Monoclonal Mesothelioma, Thyroid Carcinoma Cytoplasmic, Membranous 50 tests IgM/K Pleural biopsy, malignant mesothelioma Description Mesothelial Cell (HBME-1) Mouse Monoclonal Primary Antibody has been demonstrated to label mesothelial cells, both benign and malignant (malignant mesothelioma) and thus has been used in distinguishing mesothelioma from adenocarcinomas of various origins. More recently this antibody has been used to distinguish thyroid carcinomas (both follicular and papillary) from benign thyroid lesions. References 1. Coli A, et al., J Exp Clin Cancer Res. 26(2):221-7, 2007. 2. Cabibi D, et al., Thyroid. 17(7):603-7, 2007. 3. Torregrossa L, et al., Hum Pathol. 38(10):1482-8, 2007. 4. Barroeta JE, et al., Endocr Pathol. 17(3):225-34, 2006. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 142 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME MITF, CONFIRM (C5/D5) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 790-4367 05549175001 Mouse Monoclonal Melanoma Nuclear 50 tests IgG1 Melanoma Description CONFIRM MITF (C5/D5) Mouse Monoclonal Primary Antibody is a mouse monoclonal cocktail. This antibody cocktail reagent detects microphthalmia transcription factor (MITF) proteins 52-56 KD of MITF expressing cells in normal and neoplastic tissues. This antibody is used in the identification of melanotic lesions such as malignant melanoma and melanotic neurofibroma. References 1. Tachibana M, et al., Hum Mol Genet. 3(4):553, 1994. 2. Chang KL, et al., Adv Anat Pathol. 8(5):273, 2001. 3. Widlund HR, et al., Oncogene. 22(20):3035, 2003. MLH-1 NEW (M1) Part Number Type Control Localisation Quantity Isotype 4. King R, et al., Am J Pathol. 155(3):731, 1999. 5. Granter SR, et al., Appl Immunohistochem Mol Morphol. 10(1):47, 2002. 6. Dorvault CC, et al., Cancer. 93(5):337, 2001. 790-4535 06472966001 Mouse Monoclonal Colon, Breast, Appendix, Testis and Ovary Nuclear 50 tests IgG2a Colon carcinoma Description MLH-1 (M1) Mouse Monoclonal Primary Antibody is used to qualitatively identify human DNA mismatch repair (MMR) protein MLH1, expressed in the nucleus of normal proliferating cells. Deficient or low levels of MLH1 are associated with colorectal and other cancers. References 1. Aaltonen LA, et al. N Engl J Med. 338:1481-1487, 1998. 2. Boyer J, et al. Cancer Res. 55:6063-6070, 1995. 3. Lawes, D, et al. Br J Cancer. 93:472-477, 2005. 4. Chen Y, et al. Cancer Res. 61(10):4112-2, 2001. 5. Chen Y, et al. Cancer Res. 61(10):4112-2, 2001. 6. Caldés, T. Oncol Rep. 12:621-629, 2004. 7. Ellis NA. Am J Surg Pathol. Jan 29(1):96-104, 2005. 8. Berends MJW, et al. Am J Hum Genet. 70:26-37, 2002. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 143 IHC & ISH | Primary Antibodies by alphabetical listing HOME MSH2 (G219-1129) Part Number Type Control Localisation Quantity Isotype <PREV 760-4265 05269270001 Mouse Monoclonal Colon Mucosa, Colon Carcinoma Nuclear 50 tests IgG1 Colon Description MSH2 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colorectal Cancer (HNPCC). MSH2 (G219-1129) Mouse Monoclonal Primary Antibody is useful in screening patients and families for this condition. Colon cancers that are microsatellite unstable have a better prognosis than their microsatellite stable counterparts. References 1. Wright CL, et al., Am J Surg Pathol. 27: 1393-1406, 2003. 2. Brueckl WM, et al., Anticancer Res. 23:1773-1778, 2003. 3. Rigau V, et al., Arch Pathol Lab Med. 127:694-700, 2003. 4. Renkonen E, et al., J Clin Oncol. 21:3629-3637, 2003. MSH6, CONFIRM (44) Part Number Type Control Localisation Quantity Isotype 5. Hoedema R, et al., The Am Surgeon. 69(5):387-92, 2003. 6. Christensen M, et al., Cancer. 95:2422-30, 2002. 7. Wahlberg SS, et al., Cancer Res. 62:3485-3492, 2002. 8. Lanza G, et al., Modern Pathol. 15:741-749, 2002. 790-4455 05929911001 Mouse Monoclonal Colon Carcinoma, Breast Carcinoma Nuclear 50 tests IgG1 Gastric, normal Description CONFIRM MSH6 (44) Mouse Monoclonal Primary Antibody is used to qualitatively identify human DNA mismatch repair (MMR) protein MSH6, expressed in the nucleus of normal proliferating cells. Deficient or low levels of MSH6 are associated with colorectal and other cancers. References 1. Lawes DA, Br J Cancer. 93:472-477, 2005. 2. Miyaki M, Nat Genet. 17:271-272, 1997. 3. Offit K, J Clin Oncol. 22:4449-4451, 2004. 4. Acharya S, et al., Proc Natl Acad Sci USA. 93:13629-13634, 1996. 5. Guerrette S, et al., Mol Cell Biol. 18:6616-6623, 1996. 6. Aaltonen LA, et al., N Engl J Med. 338:1481-1487, 1998. 7. Caldés, T. et al., Oncol Rep. 12:621-629, 2004. 8. Ellis NA. Am J Surg Pathol. 29(1):96-104, 2005. 9. Berends MJW, et al., Am J Hum Genet. 70:26-37, 2002. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 144 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME MUC1 NEW (H23) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 790-4574 06316514001 Mouse Monoclonal Breast, Lung, Pancreas Membranous, Cytoplasmic 50 tests IgG Lung adenocarcinoma Description MUC1 (H23) Mouse Monoclonal Primary Antibody is directed against the membrane bound, glycosylated phosphoprotein MUC1. This antibody may be used to aid in the identification of normal and neoplastic MUC1 expressing cells. References 1. Guddo F, et al. J Clin Pathol. 51:667-71, 1998. 2. Guddo F, et al. Anticancer Res. 18:1915-20, 1998. MUC2 (MRQ-18) Part Number Type Control Localisation Quantity Isotype 3. Barratt-Boyes S. Cancer Immunol Immunother. 43:142–151, 1996. 4. Taylor-Papadimitriou J, et al. Trends Biotechnol. 12:227–233, 1994. 760-4388 05463556001 Mouse Monoclonal Colon, Colon Adenocarcinoma Cytoplasmic 50 tests IgG1/K Colon Description Mucins are high molecular weight glycoproteins which constitute the major component of the mucus layer that protects the gastric epithelium from chemical and mechanical aggressions. In humans, at least 14 mucin genes have been identified that code for the mucin proteins. They are designated as MUC1, MUC2, MUC3, MUC4, MUC5AC, MUC5B, MUC6 , MUC7, MUC8, MUC9, MUC11, MUC12, MUC13 and MUC16. Mucins share a common feature of a tandem-repeat domain rich in serine and threonine residues. These amino acid residues are potential O-glycosylation sites for attachment of the O-glycan chains that constitute up to 80% of the molecular weight of the final mucin glycoprotein. The heterogeneous pattern of mucin expression, including the expression of the intestinal mucin MUC2, may provide new insights into the differentiation pathways of gastric carcinoma. The pattern of mucin expression may also be used as a clue to bring new insights into the biological behaviour of distinct clinicopathological entities related to the localisation of gastric carcinoma, namely proximal and distal gastric carcinomas. Pinto-de-Sousa et al. have shown in a comprehensive study of gastric carcinomas evaluated for expression of several mucins (MUC1, MUC2, MUC5AC and MUC6) that: (1) mucin expression is associated with tumour type (MUC5AC with diffuse and infiltrative carcinomas and MUC2 with mucinous carcinomas) but not with the clinico-biological behaviour of the tumours; and (2) mucin expression is associated with tumour location (MUC5AC with antrum carcinomas and MUC2 with cardia carcinomas), indirectly reflecting differences in tumour differentiation according to tumour location. The following generalities apply to the patterns of Mucin expression. MUC1 expression: apical surfaces of most epithelial cells in breast, gastro-intestinal (GI), respiratory and genitourinary (GU) tracts. MUC2 expression: specifically expressed in goblet cells of the small intestine & colon. Colonic carcinomas – 65%, Gastric carcinomas – 42%, Oesophageal carcinomas – 17%. Rare outside of GI tract – with exception of mucinous carcinoma of breast and clear cell-type carcinomas of the ovary. References 1. Chaves P, et al., Dis Oesophagus. 18(6):383-7, 2005. 2. Leteurtre E, et al., World J Gastroenterol. 12(21):3324-31, 2006. 3. Mino-Kenudson M, et al., Arch Pathol Lab Med. 131(1):86-90, 2007. 4. Mizoshita T, et al., Histol Histopathol. 22(3):251-60, 2007. 5. O’Connell FP, et al., Arch Pathol Lab Med. 129(3):338-47, 2005. 6. Park SY, et al., Arch Pathol Lab Med. 131(10):1561-7, 2007. 7. Rakha EA, et al., Mod Pathol. 18(10):1295-304, 2005. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 145 IHC & ISH | Primary Antibodies by alphabetical listing HOME MUC5AC (MRQ-19) Part Number Type Control Localisation Quantity Isotype <PREV 760-4389 05463564001 Mouse Monoclonal Stomach, Associated Adenocarcinomas Cytoplasmic 50 tests IgG1 Stomach Description Mucins are high molecular weight glycoproteins which constitute the major component of the mucus layer that protects the gastric epithelium from chemical and mechanical aggressions. In humans, at least 14 mucin genes have been identified that code for the mucin proteins. They are designated as MUC1, MUC2, MUC3, MUC4, MUC5AC, MUC5B, MUC6 , MUC7, MUC8, MUC9, MUC11, MUC12, MUC13 and MUC16. Mucin genes are expressed in a regulated cell- and tissue-specific manner. The stomach provides a good example of such differential expression of mucin genes. MUC1 is detected in mucous cells of the surface epithelium and neck region of the gastric antrum, as well as in pyloric glands and oxynthic glands of the body region. MUC5AC is highly expressed in foveolar epithelium of both body and antrum, whereas MUC6 protein expression is limited to mucous neck cells of the body and pyloric glands of the antrum. The mucin expression pattern of gastric carcinoma is heterogeneous. It includes mucins normally expressed in gastric mucosa (MUC1, MUC5AC and MUC6) and de novo expression of the intestinal mucin MUC2. The heterogeneous pattern of mucin expression, including the expression of the intestinal mucin MUC2, may provide new insights into the differentiation pathways of gastric carcinoma. Pinto-de-Sousa, et al. have shown in a comprehensive study of gastric carcinomas evaluated for expression of several mucins (MUC1, MUC2, MUC5AC and MUC6) that: (1) mucin expression is associated with tumour type (MUC5AC with diffuse and infiltrative carcinomas and MUC2 with mucinous carcinomas) but not with the clinico-biological behaviour of the tumours; and (2) mucin expression is associated with tumour location (MUC5AC with antrum carcinomas and MUC2 with cardia carcinomas), indirectly reflecting differences in tumour differentiation according to tumour location. The following generalities apply to the patterns of Mucin expression: MUC5AC expression: • preferentially expressed in the normal stomach and respiratory tract • GI & pancreatobiliary ACAs • Oesophageal CAs (67%) • Gastric CAs (58%) • Colonic CAs (6-25%) • Pancreatic ductal CAs (73%) • Cholangiocarcinomas (45%) • Endocervical ACAs (70%) • Endometrial ACAs (22%) • Lung ACAs (14%) MUC1+/MUC2-/MUC5AC+ pattern: • Endocervical adenoCAs (50%) • Pancreatic ductal adenoCAs (64%) MUC1+/MUC2-/MUC5ACpattern • Ductal and lobular breast CAs (100%) • Urothelial CAs (bladder) (93%) • Renal CAs (75%) • Ovarian ACAs of various types • Most pulmonary adenocarcinomas (81%) • Endometrial (78%) adenoCAs (small subset expresses MUC5AC) MUC1-/MUC2-/MUC5AC- pattern • Hepatocellular CA • Adrenocortical CA • Prostate CA References 1. Chaves P, et al., Dis Oesophagus. 18(6):383-7, 2005. 2. Leteurtre E, et al., World J Gastroenterol. 12(21):3324-31, 2006. 3. Mino-Kenudson M, et al., Arch Pathol Lab Med. 131(1):86-90, 2007. 4. Mizoshita T, et al., Histol Histopathol. 22(3):251-60, 2007. 5. O’Connell FP, et al., Arch Pathol Lab Med. 129(3):338-47, 2005. 6. Park SY, et al., Arch Pathol Lab Med. 131(10):1561-7, 2007. 7. Rakha EA, et al., Mod Pathol. 18(10):1295-304, 2005. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 146 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME MUC6 (MRQ-20) Part Number Type Control Localisation Quantity Isotype <PREV 760-4390 05463572001 Mouse Monoclonal Stomach, Associated Adenocarcinomas Cytoplasmic 50 tests IgG1 Stomach Description Mucins are high molecular weight glycoproteins which constitute the major component of the mucus layer that protects the gastric epithelium from chemical and mechanical aggressions. In humans, at least 14 mucin genes have been identified that code for the mucin proteins. They are designated as MUC1, MUC2, MUC3, MUC4, MUC5AC, MUC5B, MUC6 , MUC7, MUC8, MUC9, MUC11, MUC12, MUC13 and MUC16. Mucin genes are expressed in a regulated cell- and tissue-specific manner. The stomach provides a good example of such differential expression of mucin genes. MUC1 is detected in mucous cells of the surface epithelium and neck region of the gastric antrum, as well as in pyloric glands and oxynthic glands of the body region. MUC5AC is highly expressed in foveolar epithelium of both body and antrum, whereas MUC6 protein expression is limited to mucous neck cells of the body and pyloric glands of the antrum. The mucin expression pattern of gastric carcinoma is heterogeneous. It includes mucins normally expressed in gastric mucosa (MUC1, MUC5AC and MUC6) and de novo expression of the intestinal mucin MUC2. The heterogeneous pattern of mucin expression, including the expression of the intestinal mucin MUC2, may provide new insights into the differentiation pathways of gastric carcinoma. Pinto-de-Sousa, et al. have shown in a comprehensive study of gastric carcinomas evaluated for expression of several mucins (MUC1, MUC2, MUC5AC and MUC6) that: (1) mucin expression is associated with tumour type (MUC5AC with diffuse and infiltrative carcinomas and MUC2 with mucinous carcinomas) but not with the clinico-biological behaviour of the tumours; and (2) mucin expression is associated with tumour location (MUC5AC with antrum carcinomas and MUC2 with cardia carcinomas), indirectly reflecting differences in tumour differentiation according to tumour location. The following generalities apply to the patterns of Mucin expression: MUC5AC expression: • preferentially expressed in the normal stomach and respiratory tract • GI & pancreatobiliary ACAs • Esophageal CAs (67%) • Gastric CAs (58%) • Colonic CAs (6-25%) • Pancreatic ductal CAs (73%) • Cholangiocarcinomas (45%) • Endocervical ACAs (70%) • Endometrial ACAs (22%) • Lung ACAs (14%) MUC1+/MUC2-/MUC5AC+ pattern: • Endocervical adenoCAs (50%) • Pancreatic ductal adenoCAs (64%) MUC1+/MUC2-/MUC5ACpattern • Ductal and lobular breast CAs (100%) • Urothelial CAs (bladder) (93%) • Renal CAs (75%) • Ovarian ACAs of various types • Most pulmonary adenocarcinomas (81%) • Endometrial (78%) adenoCAs (small subset expresses MUC5AC) • MUC1-/MUC2-/MUC5AC- pattern • Hepatocellular CA • Adrenocortical CA • Prostate CA References 1. Chaves P, et al., Dis Oesophagus. 18(6):383-7, 2005. 2. Leteurtre E, et al., World J Gastroenterol. 12(21):3324-31, 2006. 3. Mino-Kenudson M, et al., Arch Pathol Lab Med. 131(1):86-90, 2007. 4. Mizoshita T, et al., Histol Histopathol. 22(3):251-60, 2007. 5. O’Connell FP, et al., Arch Pathol Lab Med. 129(3):338-47, 2005. 6. Park SY, et al., Arch Pathol Lab Med. 131(10):1561-7, 2007. 7. Rakha EA, et al., Mod Pathol. 18(10):1295-304, 2005. NEXT> IHC & ISH | Primary Antibodies by alphabetical listing HOME MUM1 NEW (MRQ-43) Part Number Type Control Localisation Quantity Isotype <PREV 760-4529 06419208001 Rabbit Monoclonal Tonsil Nuclear, Cytoplasmic 50 tests IgG1 Description MUM1 is a 50 kD protein encoded by MUM1 gene and a member of the interferon regulatory factor family of transcription factors. MUM1/ IRF4 is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal centre (GC) B cells located in the “light zone.” This antibody stains MUM1 protein, which is expressed in a subset of B cells in the light zone of the germinal centre, plasma cells, activated T cells and a wide spectrum of related hematolymphoid neoplasms derived from these cells. Therefore, this antibody is useful for the subclassification of lymphoid malignancies and an excellent marker for Hodgkin’s and Reed-Sternberg cells of classic Hodgkin’s disease in combination with CD30 antibody. References 1. Falini B, et. al., Blood. 95:2084-92, 2000. 2. Grossman A, et. al., Genomics. 37:229-33, 1996. 3. Neresh KN, Hematologica. 92:267-8, 2007. 4. Van Imhoff GW, et. al., J Clin Oncol. 34:4135-42, 2006. 5. Gualco G, et. al., Appl Immunohistochem Mol Morphol. 18:30110, 2010. Myeloperoxidase (MPO) (polyclonal) Part Number Type Control Localisation Quantity 760-2659 05267692001 Rabbit Polyclonal Bone Marrow Cytoplasmic 50 tests Peripheral blood, granulocytes Description Myeloperoxidase Rabbit Polyclonal Primary Antibody detects granulocytes and monocytes in blood and precursors of granulocytes in the bone marrow. This antibody can detect myeloid cell populations of the bone marrow as well as in other sites. References 1. Pinkus GS, et al., Mod Pathol. 4(6): 733-41, 1991. 2. Hudock J, et al., Am J Clin Pathol. 102(1): 55-60, 1994. 3. Hamoudi WH, et al., Arch Pathol Lab Med. 124(2):315-8, 2000. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 148 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME Myogenin (F5D) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-2832 05268290001 Mouse Monoclonal Rhabdomyosarcoma Nuclear 50 tests IgG1/K Rhabdomyosarcoma Description Myogenin (F5D) Mouse Monoclonal Primary Antibody labels the nuclei of myoblasts in developing muscle tissue and is expressed in tumour cell nuclei of rhabdomyosarcoma and some leiomyosarcomas. Positive nuclear staining may occur in Wilm’s tumour. References 1. Miller JB, et al., J Cell Biol. 111(3):1149-59, 1990. 2. Wang NP, et al., Am J Pathol. 147(6):1799-810, 1995. Myoglobin (polyclonal) Part Number Type Control Localisation Quantity 3. Cui S, et al., Pathol Int. 49(1):62-8, 1999. 4. Cessna MH, et al., Am J Surg Pathol. 25(9):1150-7, 2001. 760-2660 05267706001 Rabbit Polyclonal Skeletal Muscle Cytoplasmic 50 tests Skeletal muscle with degenerative changes Description Myoglobin Rabbit Polyclonal Primary Antibody is useful for the identification of tumours of muscle origin. Since myoglobin is found exclusively in skeletal and cardiac muscle and is not present in any other cells of the human body, it may be used to distinguish rhabdomyosarcoma from other soft tissue tumours. Myoglobin antibody staining is also useful when demonstrating rhabdomyoblastic differentiation in other tumours, e.g. neurogenic sarcomas and malignant mixed mesodermal tumours of the uterus and ovary. References 1. Mukai K, et al., Am J Surg Pathol. 3:373-376, 1979. 2. Corson JM, et al., Am J Pathol. 103:384-389, 1981. 3. Kindblom LG, et al., Acta Pathol Miro. 1982; SCand C90(Sec A):167174. 4. Brooks JJ, et al., Cancer. 50:1757-1763, 1982. 5. Kahn HJ, et al., Cancer. 50:1897-1903, 1983. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 149 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV Myosin, Smooth Muscle (SMMS-1) Part Number Type Control Localisation Quantity Isotype 760-2704 05268133001 Mouse Monoclonal Intestine, Breast Cytoplasmic 50 tests IgG1/K Vascular smooth muscle Description Smooth Muscle Myosin, heavy chain (SMMS-1) is a cytoplasmic structural protein that is a major component of the contractile apparatus of the smooth muscle cells. SMMS-1 is also a myoepithelium-associated protein. SMMS-1 Mouse Monoclonal Primary Antibody is an antibody to smooth muscle myosin, heavy chain that reacts with human visceral and vascular smooth muscle cells. The antibody also reacts with human myoepithelial cells. It is very helpful in distinguishing between benign sclerosing breast lesions and infiltrating carcinomas in difficult cases since it strongly stains the myoepithelial layer in the benign lesions while it is negative in the infiltrating carcinomas. References 1. Nan Ping Wang, et al., Appl Immunohistochem. 5(3):141-151. 2. Werling RW, et al., Am J Surg Pathol. 27(1):82-90, 2003. 3. Dabbs DJ, et al., Diagn Cytopathol. 20(4):203-7, 1999. Napsin A (Polyclonal) Part Number Type Control Localisation Quantity Isotype 4. Agoff SN, et al., Appl Immunohistochem Mol Morphol. 9(2):1649, 2001. 760-4446 05973805001 Rabbit Polyclonal Lung Adenocarcinoma, Kidney Cytoplasmic 50 tests IgG Adenocarcinoma of lung Description Napsin is a pepsin-like aspartic proteinase in the A1 clan of the AA clade of proteinases. There are two closely related napsins, napsin A and napsin B. Napsin A is expressed as a single chain protein with the molecular weight of approximately 38 kD. Immunohistochemical studies revealed high expression levels of napsin A in human lung and kidney but low expression in spleen. Napsin A is expressed in type II pneumocytes and in adenocarcinomas of lung. The high specificity expression of napsin A in adenocarcinomas of lung is useful to distinguish primary lung adenocarcinomas from adenocarcinomas of other organs. References 1. Tatnell PJ, et al., FEBS Lett. 441(1):43-48, 1998. 2. Schauer-Vukasinovic V, et al., FEBS Lett. 462(1):135-9, 1999. 3. Hirano T, et al., J Cancer Res. 91(10):1015-1021, 2000. 4. Dejmek A, et al., Diagnostic Cytopathology. 35(8):493-7, 2007. 5. Jagirdar J, et al., Arch Pathol Lab Med. 132(3):384-96, 2008. 6. Suzuki A, et al., Pathol Res Pract. 201(8-9):579-86, 2005. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 150 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME Negative Control Mouse Ig (MOPC21) Part Number Type Quantity <PREV NEXT> 760-2014 05266670001 Mouse Monoclonal 250 tests Description Negative Control Mouse Ig is not directed against a known epitope present in human tissue. The reagent is intended for use as a negative control in qualitative staining of sections of routine formalin-fixed, paraffin-embedded tissue on a VENTANA automated slide stainer. Negative Control Rabbit Ig, CONFIRM Part Number Type Control Quantity 760-1029 05266238001 Rabbit Polyclonal Tonsil, Lymph Node 250 tests Description CONFIRM Negative Control Rabbit Ig is purified rabbit Ig which is not directed against a known epitope present in human tissue. The reagent is intended for use as a negative control for qualitative assessment of background staining for rabbit primary antibodies. Nerve Growth Factor Receptor (NGFR) (MRQ-21) Part Number Type Control Localisation Quantity Isotype 760-4391 05463599001 Mouse Monoclonal Neurons, Ganglia, Malignant Melanoma Cells, Myoepithelial Cells of Breast Ducts Cytoplasmic 50 tests IgG1 Breast, sclerosing adenosis Description NGFR, a 75 kd glycoprotein (also known as P-75NTR), is the first of neurotrophin receptors to be isolated and is a member of the tumour necrosis factor (TNF) receptor family. It is expressed not only in sympathetic and sensory neurons, but also in various neural crest cell or tumour derivatives such as melanocytes, melanomas, neuroblastomas, pheochromocytomas, neurofibromas and neurotised nevi (type C melanocytes). NGFR has been shown to be a reliable marker for desmoplastic and neurotropic melanoma by several groups. Although the sensitivity of NGFR staining in desmoplastic melanomas has not been systematically analysed, all reported cases stain with NGFR. A review of 9 cases of desmoplastic melanomas diagnosed in the Dermatopathology Section of the Department of Dermatology at Boston University School of Medicine between 2001 and 2004 disclosed that all 9 cases of desmoplastic melanomas tested stained positively with NGFR. These findings are in contrast to a study reported by Huttenbach, et al in which only 33% of their desmoplastic melanomas stained with NGFR. This difference emphasises the importance of the choice of monoclonal antibody to obtain consistent results. This staining property of desmoplastic melanoma cells can be useful in diagnosing challenging cases, namely early lesions, suspected cases with negative or weak S-100 staining and those that must be distinguished from a scar. It is now apparent that expression of NGFR is ubiquitous and not limited to the nervous system, being expressed in mature non-neural cells such as perivascular cells, dental pulp cells, lymphoidal follicular dendritic cells, basal epithelium of oral mucosa and hair follicles, prostate basal cells and myoepithelial cells. Unlike the high-affinity nerve growth factor tyrosine kinase receptors (TrkA, TrkB and TrkC), NGFR has no intrinsic tyrosine kinase activity. Studies in prostate and urothelial cancer suggest that NGFR may act as a tumour suppressor, negatively regulating cell growth and proliferation. NGFR antibody labels the myoepithelial cells of breast ducts and intralobular fibroblasts of breast ducts and thus aids in the diagnosis of malignancy in the breast. References 1. Laskin WB, et al., Hum Pathol. 31(10):1230-41, 2000. 2. Lewis Kelso R, et al., Dermatol Surg. 32(2):177-83, 2006. 3. Liang Y, et al., J Invest Dermatol. 111(1):114-8, 1998. 4. Liang Y, et al., J Cutan Pathol. 25(4):189-98, 1998. 5. Liang Y, et al., Arch Dermatol Res. 291(1):14-21, 1999. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 151 IHC & ISH | Primary Antibodies by alphabetical listing HOME Neurofilament (2F11) Part Number Type Control Localisation Quantity Isotype <PREV 760-2661 05267714001 Mouse Monoclonal Intestine, Breast Cytoplasmic 50 tests IgG1/K Cerebellum Description Neurofilament (2F11) Mouse Monoclonal Primary Antibody stains an antigen localised in a number of neural, neuroendocrine and endocrine tumours. Neuromas, ganglioneuromas, gangliogliomas, ganglioneuroblastomas and neuroblastomas stain positively for neurofilament. Neurofilaments are also present in paragangliomas, adrenal and extra-adrenal pheochromocytomas. Carcinoids, neuroendocrine carcinomas of the skin and oat cell carcinomas of the lung also express neurofilament. References 1. Wood JN, et al., Biosci Rep, 1:263, 1981. 2. Anderton BH, et al., Nature. 298:84, 1982. 3. Miettinen M, et al., Lab Invest. 52:429-436, 1985. 4. Van Muijen GNP, et al., Am J Pathol. 116:363-369, 1984. 5. Trojanowski JQ, et al., N Eng J Med. 313:101-104, 1985. 6. Morrison CD, et al., Semin Diagn Pathol. 17(3):204-15, 2000. 7. Dubovy SR, et al., Br J Opthalmol.85(8):949-51, 2001. 8. Erana-Rojas IE, et al. Ann Diagn Pathol. 6(5):265-71, 2002. NSE (Neuron Specific Enolase) (E27) Part Number Type Control Localisation Quantity Isotype 760-2662 05267722001 Mouse Monoclonal Pancreas Cytoplasmic 50 tests IgG1 Pancreas, islets of Langerhans Description Neuron Specific Enolase is present in high concentration in neurons and in central and peripheral neuroendocrine cells, therefore, NSE (E27) Mouse Monoclonal Primary Antibody reacts with cells of neural and neuroendocrine lineage. If neoplastic cells co-express keratins and NSE, neuroendocrine differentiation is probable, however, neural tumours that do not express keratin and show no staining with NSE would not exclude neural or neuroendocrine differentiation. Thus, detection of neural and neuroendocrine lineage requires the use of panels that include NSE and other markers such as keratin, chromogranin, synaptophysin and neurofilament. References 1. Perentes E, et al., Arch Pathol Lab Med. 111:796-812. 1987. 2. Cras P, et al., Ann Neurol. 20:106-17, 1986. 3. Schmechal D, et al., Lab Invest. 52:239-242, 1985. 4. Dhillon AP, et al., Histopathology. 6:81-92, 1982. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 152 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME Oct-2 (MRQ-2) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-4447 05973791001 Mouse Monoclonal Lymph Node, Tonsil Nuclear 50 tests IgG1/K Tonsillar hypertrophy Description Oct-2 is a transcription factor of the POU homeo-domain family that binds to the Ig gene octamer sites, regulating B-cell-specific genes. These are involved in proliferation and differentiation and despite the scarce evidence for Oct-2 expression in T cells, it has been shown that this factor participates in transcriptional regulation during T-cell activation. Oct-2 activity is dependent on phosphorylation and alternative splicing, although it seems that the level of its expression can be used as a marker of B-cell lineage and differentiation. The following show high levels of Oct-2 expression: germinal centre B-cells, mantle B-cells, monocytoid B-cells and plasma cells. Various lymphomas are also positive for this marker including the following: B-chronic lymphocytic leukaemia, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, plasmacytoma, Burkitt’s lymphoma, diffuse large cell lymphoma, diffuse large B-cell lymphoma, T-cell rich B-cell lymphoma, nodular lymphocyte predominant Hodgkin’s lymphoma, classic Hodgkin’s lymphoma. Several studies of Oct-2 expression have shown a low level expression in pre-B, T-cell, myelomonocytic and epithelial cell lines, whereas all mature B-cell lines display high levels of expression. Analysis of Oct-2 expression in primary Hodgkin’s lymphoma (HLs) and cell lines derived from it showed that the tumour cells analysed had high levels of expression and activity, suggesting a common B cell origin for all types of HLs. References 1. Browne P, et al., Am J Clin Pathol. 120(5):767-77, 2003. 2. García-Cosío M, et al., Mod Pathol. 17(12):1531-8, 2004. 3. Gibson SE, et al., Am J Clin Pathol. 126(6):916-24, 2006. 4. Hallermann C, et al., J Am Acad Dermatol. 56(4):588-97, 2007. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 153 IHC & ISH | Primary Antibodies by alphabetical listing HOME Oct-4 (MRQ-10) Part Number Type Control Localisation Quantity Isotype <PREV 760-4392 05463602001 Mouse Monoclonal Seminoma, Dysgerminoma Nuclear 50 tests IgG Seminoma Description OCT-4 is a transcription factor that maintains and regulates pluripotency in embryonic stem and germ cells. It has a very high sensitivity and specificity in seminoma/dysgerminoma and embryonal carcinoma and in the germ cell component of gonadoblastoma by nuclear immunostaining. Clear cell carcinoma may enter the differential diagnosis of dysgerminoma as both may grow in nests or tubules, contain clear cells and have a prominent inflammatory infiltrate (lymphocytes in dysgerminoma and plasma cells in clear cell carcinoma). In one study that looked at OCT-4 staining in clear cell carcinomas, 4 of 14 tumours were found to be focally positive. In another study, 49 endometrioid carcinomas were OCT-4 negative. Rarely dysgerminoma may have a morphologic appearance that overlaps with sex cordstromal tumours, expecially poorly differentiated Sertoli cell tumours. In two studies, however, all sex cord-stromal tumours of the testis and granulose cell tumours of the ovary were OCT-4 negative. References 4. Cools M, et al., J Clin Endocrinol Metab. 91(6):2404-13, 2006. 1. Baker PM, et al., Int J Gynecol Pathol. 24(1):39-55, 2005. Review. Epub 2006 Apr 11. 2. Biermann K, et al., Histopathology. 49(3):290-7, 2006. 3. Cheng CJ, et al., J Biomed Sci. 14(6):797-807, 2007. Epub 2007 Aug 8. 5. Gidekel S, et al., Cancer Cell. 4(5):361-70, 2003. p21WAF1 (DCS-60.2) Part Number Type Control Localisation Quantity Isotype 760-4453 05973961001 Mouse Monoclonal Non-Small Cell Lung Carcinoma, Colon Nuclear 50 tests IgG2a Colon mucosa, hyperplastic polyp Description p21 is a nuclear 21kD protein, a product of the WAF1/CIP1 gene. It is a cyclin-dependent kinase inhibitor 1A (p21, Cip1), also known as CDKN1A, which in humans is encoded by the CDKN1A gene located on chromosome 6p21.2. It is a constituent of a large complex of nuclear proteins, including cyclins, cyclin dependent kinases and PCNA (Proliferating Cell Nuclear Antigen). Cell cycle progression is regulated by cyclins and their cognate Cdks. p21 inhibits the activity of each member of the cyclin/Cdk family. The expression of this gene acts as an inhibitor of the cell cycle during G1 phase and is tightly controlled by the tumour suppressor protein p53. Normal cells generally display a rather intense nuclear p21 expression. Loss of p21 expression has been associated with poor prognosis in several carcinomas (gastric carcinoma, non-small cell lung carcinoma and thyroid carcinoma). References 1. DiGiuseppe JA, et al., Am J Pathol. 147(4):884-8, 1995. 2. Gomyo Y, et al., Cancer. 79(11):2067-2072, 1997. 3. Ikeguchi M, et al., Dig Dis Sci. 43(5):964-70, 1998. 4. Marone M, et al., Leuk Lymphoma. 43(1):51-7, 2003. 5. Kwon MS, et al., Pathol Res Pract. 202(12):849-56, 2006. 6. Merola E, et al., J Cell Physi. 207(2):512-519, 2006. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 154 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME p27kip1 (SX53G8) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-4268 05269300001 Mouse Monoclonal Non-Small Cell Lung Carcinoma, Colon Cytoplasmic 50 tests IgG1/K Lymph node Description p27 is a cyclin-dependent kinase inhibitor which regulates progression from G1 to S phase by binding and inhibiting cyclin-dependent kinases. Low p27 expression has been associated with unfavourable prognosis in renal cell carcinoma, colon carcinoma, small breast carcinoma, non-small cell lung carcinoma, hepatocellular carcinoma, multiple myeloma, lymph node metastases in papillary carcinoma of the thyroid and more aggressive phenotype in a carcinoma of the cervix. References 1. Lloyd RV, et al., Am J Pathol. 154:313-323, 1999. 2. Migita T, et al., Cancer. 94:973-9, 2002. 3. Haitel A, et al., Urology. 58:477-481, 2001. p53 (Bp-53-11) Part Number Type Control Localisation Quantity Isotype 4. Tan P, et al., Cancer Research. 57-1259-1263, 1997. 5. Esposito V, et al., Cancer Research. 57:3381-3385, 1997. 6. Khoo MLC, et al., J Clin Endocrinol Metab. 87:1814-1818, 2002. 760-2542 05267102001 Mouse Monoclonal Colon Adenocarcinoma Nuclear 50 tests IgG2a Bladder transitional cell carcinoma Description p53 (Bp53-11) Mouse Monoclonal Primary Antibody is directed against both the mutant and wild type of the p53 nuclear phosphoprotein. Very rare normal cells express p53, but alterations in the p53 suppressor gene result in an overproduction of this protein in malignancies. This reagent may be used to aid in the identification of abnormally proliferating cells in neoplastic cell populations. p53 (Bp53-11) antibody specifically binds to nuclear antigen(s) associated with the normal down regulation of cell division. Increased expression of p53 in actively dividing cells is an indication of loss of function due to mutation of the p53 gene. References 1. Mayall FG, et al., J Pathol. 168:377-381, 1992. 2. Van den Berg FM, et al., Am J Pathol. 142:381-385, 1993. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 155 IHC & ISH | Primary Antibodies by alphabetical listing HOME p53, CONFIRM (DO-7) Part Number Type Control Localisation Quantity Isotype <PREV 800-2912 05278775001 Mouse Monoclonal Colon Adenocarcinoma Nuclear 50 tests IgG1/K Colon carcinoma Description The wild type p53 molecule has a role in transcription, in cell cycle control and in many other metabolic functions. It is also a tumour suppressor in that it halts abnormal growth in normal cells; however, a mutation in one of its 393 amino acids can eliminate the surveillance capability of the protein and allow expression of malignant phenotype. Approximately 50% of all human cancers contain a mutation in p53. The wild type molecule has a short half life, is present in low concentrations and cannot usually be detected by IHC. Many of the mutations in p53 increase its half life and cause intranuclear accumulation of the mutant protein. Thus in many malignancies of the colon, stomach, bladder, breast, lung, testes and in melanomas and soft tissue sarcomas, p53 protein can be readily detected in the malignant cells by IHC. Immunostaining closely correlates with the presence of a mutation. The staining pattern with the CONFIRM p53 (DO-7) Mouse Monoclonal Primary Antibody is exclusively nuclear and may be present in a heterogeneous pattern. References 1. Mayall FG, et al., J Pathol. 168:377-381, 1992. p63 (4A4) Part Number Type Control Localisation Quantity Isotype 2. Van den Berg FM, et al., Am J Pathol. 142:381-385, 1993. 790-4509 05867061001 Mouse Monoclonal Prostate, Tonsil Nuclear 50 tests IgG2a/K Prostate Description VENTANA p63 (4A4) Mouse Monoclonal Primary Antibody is directed against the p63 molecule which is highly expressed in the nuclei of human prostatic basal cells and urothelial tissues. This antibody may be used to aid in the differentiation of benign and malignant prostatic lesions. References 1. Yang A, et al., Mol Cell. 2:305-16, 1998. 2. Grisanzio C, et al., J Cell Biochem. 103:1354-1368, 2008. 3. Yang A, et al., Nature. 398:714-718, 1999. 4. Signoretti S, et al., J Pathol. 157:1769-1775, 2000. 5. Wu HH, et al., Appl Immunohistochem Mol Morph. 12:285-289, 2004. 6. Shah RB, et al., Am J Surg Pathol. 26:1161-1168, 2002. 7. Weinstein MH, et al., Mod Pathol. 15:1302-1308, 2002. 8. Harton AM et al., Am J Clin Pathol. 128:80-85, 2007 Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 156 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME p120 NEW (98) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 790-4517 05867088001 Mouse Monoclonal Tonsil Membranous (ductal), Cytoplasmic (lobular) 50 tests IgG1 Description p120 catenin (98) Mouse Monoclonal Primary Antibody is directed against human juxtamembrane protein p120 expressed as a part of the cell-cell adhesion complex in epithelial tissues. Cytoplasmic accumulation of p120 is associated with lobular breast carcinoma, whereas ductal neoplasms retain membranous localisation. References 1. Dabbs DJ, et al., Am J Surg Pathol. 31(3):427-37, 2007. 2. Anastasiadis PZ., Biochimica et Biophysica Acta. 1773:34-46, 2007. 3. Mastracci TL, et al., Modern Pathology. 18:741-751, 2005. 4. Thoreson MA, et al., Differentiation. 70:583-589, 2002. 5. Thoreson MA, et al., J of Cell Bio. 148(1):189-201, 2000. Parathyroid Hormone (PTH) NEW (MRQ-31) Part Number Type Control Localisation Quantity Isotype 760-4532 06419224001 Mouse Monoclonal Parathyroid Cytoplasmic, Membranous 50 tests IgG2a Description PTH (MRQ-31) Mouse Monoclonal Primary Antibody is useful to distinguish parathyroid hyperplasia/neoplasms from thyroid and metastatic neoplasms; although the pathologist is typically aware of the pre-operative hypercalcaemic status. Occasionally when the surgeon does not supply this information PTH immunohistochemistry is essential. Even more problematic are situations in which clear cell parathyroid carcinomas are non-secretory without an abnormality in mineral metabolism. References 1. Brown E, Mineral Electrolyte Metal. 8:130-50, 1982. 2. Chen HL, et. al. Journal of Biology and Chemistry. 277:19374-81, 2002. 3. Wick MR, et. al., Seminars in Diagnostic Pathology. 14:183-202, 1997. 4. Permanetter W, et. al., American Journal of Surgical Pathology. 7:535-46, 1983. 5. Aldinger KA, et. al., Cancer. 49:388-97, 1982. 6. Murphy MN, et. al. Cancer. 58:2468-76, 1986. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 157 IHC & ISH | Primary Antibodies by alphabetical listing HOME PAX5, CONFIRM (SP34) Part Number Type Control Localisation Quantity <PREV 790-4420 05552729001 Rabbit Monoclonal Tonsil, Spleen Nuclear 50 tests Lymphoma Description CONFIRM PAX5 (SP34) Rabbit Monoclonal Primary Antibody is directed against a nuclear epitope present in human B lymphocytes. This antibody may be used to aid in the identification of normal and neoplastic cells of B-lymphocytic lineage. References 1. Adams B, et al., Genes Dev. 6(9):1589-1607, 1992. 2. Cobaleda C, et al., Nat Immunol. 8(5):463-470, 2007. 3. Holmes ML, et al., Immunol Cell Biol. 86(1):47-53, 2008. 4. Feldman AL, et al., Adv Anat Path. 14(5):323-334, 2007. 5. Jensen KC, et al., Mod Pathol. 20(8):871-877, 2007. 6. Mhawech-Fauceglia P, et al., J Clin Pathol. 60(6):709-714, 2007. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 158 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> PD-1 (also known as NAT) (MRQ-22) Part Number Type Control Localisation Quantity Isotype 760-4448 05973783001 Mouse Monoclonal Lymph Node, Tonsil Cytoplasmic 50 tests IgG1 Tonsillar hypertrophy Description Programmed death-1 (PD-1) is a member of the CD28 family of receptors that includes CD28, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), inducible costimulator (ICOS) and Band T-lymphocyte attenuator. These receptors play a role in the cellular immune response. For example, CD28 serves as a costimulatory receptor that enhances T-cell activation, whereas CTLA-4 serves as an inhibitor of T-cell activation. PD-1 also has an inhibitory function on T cells and B cells and is important in peripheral tolerance. There are at least 2 ligands for PD-1: PD-L1 and PD-L2, which are expressed on a range of cells. CD28 is constitutively expressed on most or all CD4+ T cells and approximately 50% of CD8+ T cells, whereas CTLA-4 is not expressed on resting T cells. PD-1 is also expressed on activated T cells, B cells and myeloid cells. Iwai and coworkers studied the microanatomic distribution of PD-1 in human tonsil and found that PD-1 is expressed on most T cells and a small subset of B cells in the light zone of germinal centres, but not elsewhere in the tonsil. On that basis, it was postulated that PD-1 may play a role in the process of clonal selection of centrocytes, which occurs in this subanatomic site in germinal centres. PD-1 is a new marker of angioimmunoblastic lymphoma and suggests a unique cell of origin for this neoplasm. Unlike CD10 and bcl-6, PD-1 is expressed by few B cells, so it may be a more specific and useful diagnostic marker in angioimmunoblastic lymphoma. It also seems to stain a greater percentage of CD3-positive neoplastic cells in angioimmunoblastic lymphoma than either CD10 or bcl-6. In addition, PD-1 expression provides new evidence that angioimmunoblastic lymphoma is a neoplasm derived from germinal centre-associated T cells. PD-1 expression in angioimmunoblastic lymphoma lends further support to this model of T-cell oncogenesis, in which specific subtypes of T cells may undergo neoplastic transformation and result in specific distinct histologic, immunophenotypic and clinical subtypes of T-cell neoplasia. References 1. Bolstad AI, et al., Arthritis Rheum. 48(1):174-85, 2003. 2. Dorfman DM, et al., Am J Surg Pathol. 30(7):802-10, 2006. 3. Hamanishi J, et al., Proc Natl Acad Sci U S A. 104(9):3360-5, 2007. 4. Iwai Y, et al., Immunol Lett. 83(3):215-20, 2002. 5. Kobayashi M, et al., J Rheumatol. 32(11):2156-63, 2005. 6. Konishi J, et al., Clin Cancer Res. 10(15):5094-100, 2004. 7. Mataki N, et al., Am J Gastroenterol. 102(2):302-12, 2007. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 159 IHC & ISH | Primary Antibodies by alphabetical listing HOME Perforin (MRQ-23) Part Number Type Control Localisation Quantity Isotype <PREV 760-4394 05463637001 Mouse Monoclonal Tonsil, Lymph Node Perinuclear Cytoplasmic 50 tests IgG1 Lymphoma Description Perforin is a pore-forming protein that leads to osmotic lysis of the target cells and subsequently enables granzymes to enter the target cells and activate apoptosis, the cell death program. The expression of perforin is upregulated in activated CD8+ T cells, but in NK cells the expression is constitutively very high and stable. Perforin expression can also be stimulated in some activated CD4+ T cells. CD8+ T cells and NK cells use both the perforin ⁄ granzyme and the Fas ⁄ FasL pathways, while CD4+ T cells preferentially use the Fas ⁄ FasL pathway. Although some investigators report a cytolytic potential of CD4+ T cells, it appears more likely that CD8+ T cells are the major effector population in Th1- associated inflammatory skin diseases. The role of perforin-mediated cytotoxicity has been demonstrated in various auto-immune diseases. In vitro and in vivo studies suggest that the cytotoxicity of CTLs may be mediated by cytotoxic granules in certain inflammatory diseases in humans. In addition, it seems that T-cell cytotoxicity against keratinocytes is mediated by perforin in some inflammatory skin diseases. Other authors suggest that perforin may have a dual role in alloimmune response (organ transplant applications). In one regard, it has a cytolytic function in acute rejection and, in contrast, it may be responsible for downregulating both CD4- and CD8-mediated alloimmune response. References 1. Chu PG, et al., Ann Diagn Pathol. 3(2):104-33, 1999. Review. 2. Bittmann I, et al., Virchows Arch. 445(4):375-81, 2004. Epub 2004 Jul 29. PGP 9.5 (polyclonal) Part Number Type Control Localisation Quantity Isotype 3. d’Amore ES, et al., Pediatr Dev Pathol. 10(3):181-91, 2007. 760-4434 05973953001 Rabbit Polyclonal Nerve Tissue, Bowel Wall (Interstitial Cells of Cajal) Cytoplasmic 50 tests IgG Small bowel wall, peritonitis Description Protein gene product 9.5 (PGP 9.5), also known as ubiquitin carboxylterminal hydrolase-1 (UCH-L1), is a 27-kD protein originally isolated from whole brain extracts (1). Although PGP 9.5 expression in normal tissues was originally felt to be strictly confined to neurons and neuroendocrine cells (2), it has been subsequently documented in distal renal tubular epithelium, spermatogonia, Leydig cells, ovocytes, melanocytes, prostatic secretory epithelium, ejaculatory duct cells, epididymis, mammary epithelial cells, Merkel cells and dermal fibroblasts. LK Campbell, et al. demonstrated immunostaining of a plethora of different mesenchymal neoplasms with this antibody. References 1. Bassotti G, et al., J Clin Pathol. 58(9):973-7, 2005. 2. Campbell LK, et al., Mod Pathol. 16(10):963-9, 2003. 3. Kasprzak A, et al., Pol J Pathol. 58(1):23-33, 2007. Review. 4. Mahalingam M, et al., J Cutan Pathol. 28(6):282-6, 2001. 5. Mahalingam M, et al., J Cutan Pathol. 33(1):51-6, 2006. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 160 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> Phosphohistone-H3 (PHH3) NEW (polyclonal) Part Number Type Control Localisation Quantity 760-4591 06433405001 Rabbit Polyclonal Tonsil Nuclear 50 tests Breast infiltrating ductal carcinoma Description Phosphohistone-H3 Rabbit Polyclonal Primary Antibody is used as an aid in identification of mitotic activity in tumour cells and diagnosis of tumour grade differentiation within the context of an antibody panel, the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist. References 1. Mehra R, et al. Mod Path, 20:538-544, 2007. 2. Gurley, LR. Et al. J Biol Chem. 268:18431-4, 1993. 3.Hendzel, MJ, et al. J Biol Chem. 273:24470-8, 1998. 4. Colman H. et al. Am J Surg Pathol. 30:657-64, 2006. 5. Nasr MR, et al. Am J Dermatopathol. 30:117-22, 2008. 6. Kim YJ, et al. Am J Clin Pathol 128:118-25, 2007. Placental Alkaline Phosphatase (PLAP) (NB10) Part Number Type Control Localisation Quantity Isotype 760-2664 05267757001 Mouse Monoclonal Placenta Cytoplasmic 50 tests IgG Placenta, cytotrophoblasts Description PLAP (NB10) Mouse Monoclonal Primary Antibody immunoreacts with germ cell tumours and can discriminate between these and other neoplasms. Somatic neoplasms (e.g. breast, gastro-intestinal, prostatic and urinary cancers) may also immunoreact with antibodies to PLAP. PLAP antibody positivity in conjunction with keratin negativity favours seminoma over carcinoma. Germ cell tumours are usually keratin positive, but they regularly fail to stain with EMA antibody, whereas most carcinomas stain with EMA antibody. This antibody has shown cross-reaction with human intestinal alkaline phosphatase. References 1. Jacobsen GK, et al., Acta Path Microb Immuno Scand Sect A. 92:323-329, 1984. 2. Paiva J, et al., Am J Pathol. 111:156-165, 1984. 3. Burke AP, et al., Hum Path. 19:663-670, 1988. 4. Manivel JC, et al., Am J Surg Path. 11:21-29, 1987. 5. Wick MR, et al., Hum Path. 18:946-954, 1987. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 161 IHC & ISH | Primary Antibodies by alphabetical listing PMS2 NEW (EPR3947) Part Number Type Control Localisation Quantity Isotype 760-4531 06419216001 Rabbit Monoclonal Colon Nuclear 50 tests IgG Description Microsatellite instability (MSI) is characterised by genome-wide alterations in short, repetitive DNA sequences. It is caused by defects in the nucleotide mismatch repair (MMR) system. Biologically, defective MMR results in a general increase in the mutation rate and the development of a mutator phenotype. In colorectal cancer (CRC), high-level MSI was first described in tumours from patients with hereditary non-polyposis colorectal cancer (HNPCC). PMS2 (EPR3947) Rabbit Monoclonal Primary Antibody is a useful diagnostic and prognostic marker for hereditary non-polyposis colorectal cancer (HNPCC). References 1. Hampel H, et. al., N Engl J Med. 352:1851-60, 2005. 2. Gologan A, et. al., Clin Lab Med. 25:179-96, 2005. 3. Lagerstedt Robinson K, J Natl Cancer Inst. 99:291-9, 2007 4. Hendriks YM, et. al., Gastroenterology. 130:312-22, 2006. 5. Truninger K, et. al., Gastroenterology. 128:1160-71, 2005. 6. Warusavitarne J, et al., J Colorectal Dis. 22: 739-748, 2007. 7. Gill S, et. al., Clin Cancer Res. 11:6466, 2005. Pneumocystis jiroveci (carinii) (3F6) Part Number Type Control Localisation Quantity Isotype 760-2665 05267765001 Mouse Monoclonal Infected Tissue Membranous 50 tests IgM/K Description Pneumocystis jiroveci (carinii) is a fungal organism which is detected in human tissues (typically in lung in immunocompromised patients) in the trophozoite stage. Pneumocystis jiroveci (carinii) (3F6) Mouse Monoclonal Primary Antibody reacts with an epitope on the organism which is resistant to formalin, picric acid, paraffin, as well as alcohol and xylene. No cross-reactivity has been demonstrated with other fungi or parasitic organisms. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 162 Primary Antibodies by alphabetical listing | IHC & ISH Podoplanin (D2-40) Part Number Type Control Localisation Quantity Isotype 760-4395 05463645001 Mouse Monoclonal Lymph Node, Lymphangioma Cytoplasmic 50 tests IgG1 Tonsil Description Podoplanin is a transmembrane mucoprotein (38 kd) recognised by the D2-40 Mouse Monoclonal Primary Antibody. Podoplanin is selectively expressed in lymphatic endothelium as well as lymphangiomas, Kaposi sarcomas and in a subset of angiosarcomas with probable lymphatic differentiation. Podoplanin has also been shown to be expressed in epithelioid mesotheliomas, hemangioblastomas and seminomas. References 1. Ordonez N, Adv Anat Pathol. 13(2):83-8, 2006. 2. Ordonez N, Hum Pathol. 36(4):372-80, 2005. 3. Niakosari F, et al., Arch Dermatol. 141(4):440-4, 2005. 4. Galambos C, et al., Pediatr Dev Pathol. 8(2):191-9, 2005. 5. Fukunaga M, Histopathology. 46(4):396-402, 2005. 6. Chu AY, et al., Mod Pathol. 18(1):105-10, 2005. 7. Franke FE, et al., J Cutan Pathol. 31(5):362-7, 2004. 8. Fogt F, et al., Oncol Rep. 11(1):47-50, 2004. 9. Kahn HJ, et al., Mod Pathol. 15(4):434-40, 2002. Progesterone Receptor (PR), CONFIRM (1E2) Part Number Type Control Localisation Quantity Isotype 790-2223 05277990001 (50 tests); 790-4296 05278392001 (250 tests) Rabbit Monoclonal Breast Nuclear 50 tests (790-2223), 250 tests (790-4296) IgG Breast Ductal Carcinoma Description CONFIRM PR (1E2) Rabbit Monoclonal Primary Antibody is intended for laboratory use for the qualitative detection of progesterone receptor (PR) antigen in sections of formalin-fixed, paraffin-embedded tissue on a VENTANA automated slide stainer with VENTANA detection kits and ancillary reagents. CONFIRM PR (1E2) that recognises the A and B forms of human progesterone receptor and is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. One of the important markers in breast cancer today is progesterone receptor (PR), due to its role in determining the functionality of estrogen receptors present in breast cancer cells. The presence of estrogen receptor (ER), however, does not guarantee a response to endocrine therapy. Half of all patients with ER positive primary tumours fail to respond. In tumour cells, genetic expression is often inaccurate, leading to variant protein expression. It is proposed that mutant ER, that no longer bind estrogen or that no longer perform signal transduction, may be the cause of the failure to respond to endocrine therapy. One way to evaluate the functionality of the ER present in a breast carcinoma is to determine if proteins regulated by ER are expressed. Progesterone receptor is such a protein and has been used to monitor for functional ER for many years. References 1. Bevitt DJ, Milton ID, et al., J. Pathol. 83(2):228-232, 1997. 2. Dickson RB, Lippman ME, et al., Kluwer Acad, Publ. 1992; 285-286. 3. Wei LL, et al., Cancer Res. 54(2):340-3, 1994. 4. Doglioni C, et al., Am. J. Pathol. 137(5):999-1005, 1990. 5. Greene GL, et al., Immun. Appr. Diag. and Ther. Breast Cancer. 119135, 1987. 6. Press MF, Greene GL, et al., Endocrinology. 122(3):1165-1175, 1988. 7. Winborn WB, Sheridan PJ, et al., Pancreas. 2(3):289-94, 1987. 8. Money SR, Muss W, et al., Surgery. 106(6):975-8, 1989. 9. Roche PC, et al., Mayo Clin. Proc. 69(1):57-58, 1994. 10. PDQ. http://icisun.nci.nih…t_cancer_Physician.html. 11. Horwitz KB, et al., J. Steroid Biochem. Mol. Biol. 49(4-6):295302, 1994. 12. Van Agthoven T, Timmermans M, et al., Int. J. Cancer. 63(6):790793, 1995. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 163 IHC & ISH | Primary Antibodies by alphabetical listing HOME Prolactin (polyclonal) Part Number Type Control Localisation Quantity <PREV 760-2803 05268249001 Rabbit Polyclonal Normal Pituitary Cytoplasmic 50 tests Pituitary Description Prolactin Rabbit Polyclonal Primary Antibody is a useful marker in classification of pituitary tumours and the study of pituitary disease. It reacts with prolactin-producing cells. Such prolactin-producing cells can also be found in prostate epithelium. References 1. Asa SL, et al., Arch Pathol Lab Med. 106:360, 1982. 2. Duello TM, et al., Amer J Anat. 158:463, 1980. 3. Minniti G, et al., Surg Neurol. 57(2):99-103, 2002. 4. Popadic A, et al., Surg Neurol. 51(1):47-54, 1999. 5. Nevalainen MT, et al., J Clin Invest. 99(4):618-27, 1997. PSA (Prostate Specific Antigen), CONFIRM (polyclonal) Part Number Type Control Localisation Quantity Isotype 760-2506 05266939001 Rabbit Polyclonal Prostate Cytoplasmic 50 tests IgG Prostate Description CONFIRM Prostate Specific Antigen (PSA) is directed against both free and bound human prostate specific antigen (PSA). PSA is a 33-34 kD chymotrypsin like serine protease (kallikrein family) specifically expressed by prostate epithelium. PSA is present in the cytoplasm of benign and malignant prostate epithelium. It is useful for identification of adenocarcinoma of the prostate in metastatic sites and for differentiating prostate adenocarcinoma from urothelial carcinoma. References 1. Nadji M, et al., Cancer. 48(5):1229-1232, 1981. 2. Oesterling JE, J Urology. 145(5):907-923, 1991. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 164 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> PSAP (Prostatic Acid Phosphatase) (PASE/4LJ) Part Number Type Control Localisation Quantity Isotype 760-4272 05269342001 Mouse Monoclonal Prostate Cytoplasmic 50 tests IgG1 Prostate Description PSAP (PASE/4LJ) Mouse Monoclonal Primary Antibody reacts with prostatic acid phosphatase in the glandular epithelium of normal and hyperplastic prostate, carcinoma of the prostate and metastatic cells of prostatic carcinoma. This marker may be helpful in pinpointing the site of origin in cases of metastatic carcinoma of the prostate and is considered a more sensitive marker than PSA. However, it offers less specificity. Nevertheless, PSAP complements PSA in the right clinical context. References 1. Ansari MA, et al., Am J Clin Path. 76:94-98, 1981. 2. Nadji M, et al., Ann NY Acad Sci. 390:133-141, 1982. 3. Kimura N, et al., Virchows Arch A. 4:247-251, 1986. 4. Kidwai N, et al., Breast Cancer Res. 6(1):R18-23, 2004. 5. Kuroda N, et al., Pathol Int. 49(5):457-61, 1999. 6. Elgamal AA, et al., Urology. 44(1):84-90, 1994. Renal Cell Carcinoma (RCC) (PN-15) Part Number Type Control Localisation Quantity Isotype 760-4273 05269369001 Mouse Monoclonal Kidney, Renal Cell Carcinoma Cytoplasmic, Membranous 50 tests IgG1/K Kidney Description Renal Cell Carcinoma (PN-15) Mouse Monoclonal Primary Antibody recognises a 200 kD glycoprotein localised in the brush border of the proximal renal tubule. This antibody immunoreacts with approximately 90% of primary renal cell carcinomas and approximately 85% of metastatic renal cell carcinomas. Other tumours that may react with this antibody are parathyroid adenoma, an occasional breast carcinoma. Nephroblastoma, oncocytoma, mesoblastic nephroma, transitional cell carcinoma and angiomyolipoma are not labelled with this antibody. References 1. Avery AK, et al., Am J Surg Pathol. 24(2):203-210, 2000. 2. McGregor DK, et al., Am J Surg Pathol. 25(12):1485-1492, 2001. 3. Gokden N, et al., Appl Immunohistochem Mol Morphol. 11(2):116-9, 2003. 4. Ordonez NG, et al., Human Pathology. 35(6):697-710, 2004. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 165 IHC & ISH | Primary Antibodies by alphabetical listing HOME S100, CONFIRM (4C4.9) Part Number Type Control Localisation Quantity Isotype <PREV 790-2914 05278104001 Mouse Monoclonal Melanoma Cytoplasmic 50 tests IgG2a Melanoma Description S100 was first detected in nervous tissue and has subsequently been found in a number of other cell types including glial and neural cells, Schwann cells, melanocytes and nevus cells, cells of cartilaginous and fatty tissue, myoepithelial cells and also Langerhans cells. S100 is a sensitive marker for melanoma. Antibodies against S100 stain amelanotic melanomas more strongly than pigmented tumours and detect melanomas that are often negative for other melanocytic markers, such as desmoplastic melanomas. Although S100 is highly sensitive for melanomas, many non-melanocytic tumours also show S100 positivity. S100 typically is present in neural cells (glial cells and Schwann cells) and their corresponding tumours. References 1. Taylor RT, et al., W.B. Saunders Co, Philadelphia, 1994. S100, CONFIRM (polyclonal) Part Number Type Control Localisation Quantity 2. Kahn HJ, et al., Amer. J. Clin. Pathol. 1983; 79(3): 341-347. 760-2523 05267072001 Rabbit Polyclonal Melanoma Cytoplasmic 50 tests Melanoma Description CONFIRM S100 Rabbit Polyclonal Primary Antibody contains rabbit antiserum directed against an epitope found on S100 protein and may be used to aid in the identification of cells of normal and abnormal neuronal and neuroendocrine lineage and as an aid in the diagnosis of anaplastic tumours. S100 is a sensitive marker for melanoma. It stains amelanotic melanomas more strongly than pigmented tumours and detects melanomas that are often negative for other melanocytic markers such as desmoplastic melanomas. The staining is cytoplasmic, the proportion of positive cells varying from 10 to 70 percent or more. Although S100 is highly sensitive for melanomas, many non-melanocytic tumours also show S100 positivity. S100 typically is present in neural cells (glial cells and Schwann cells) and their corresponding tumours.1 An advantage of the ubiquity of strongly immunoreactive S100 protein in peripheral nerves, which are present in almost any section of normal or diseased tissue, is that it provides a built in positive control for most immunostains for S100. References 1. Taylor RT, et al., WB Saunders Co, Philadelphia, 1994. 2. Kahn HJ, et al., Amer J Clin Pathol. 79(3):341-347, 1983. 3. True L. Atlas of Diagnostic Immunohistopathology. 1990. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 166 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME Smoothelin NEW (R4A) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-4592 06433278001 Mouse Monoclonal Bladder, Leiomyosarcoma Cytoplasmic (MP), Nuclear 50 tests IgG1 Urinary transitional cell carcinoma Description Smoothelin (R4A) Mouse Monoclonal Primary Antibody is used as an aid in the distinction of terminally differentiated smooth muscle cells, smooth muscle neoplasms of the gastro-intestinal tract and other organs and staging of bladder carcinoma within the context of an antibody panel, the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist. References 1. Kramer, J et al. J Mol Med. 77:294-8, 1999. 2. van der Loop, FT et al. J Cell Biol. 134:401-411, 1996. 3. Maake, C et al. J Urol. 175:1152-1157, 2006. 4. Jimenez, RE et al. Adv Anat Pathol. 7:13-25, 2000. 5. Kuijpers, et al. Eur Urol. 52:1213-21, 2007. Somatostatin (polyclonal) Part Number Type Control Localisation Quantity 6. Paner, GP et al. Am J Surg Pathol. 33:91-8, 2009. 7. Paner, GP et al. Am J Surg Pathol. 34:792-9, 2010. 8. Council, L et al. Mod Pathol. 22:639-650, 2009. 9. Coco, DP et al. Am J Surg Pathol. 33(12):1795-801, 2009. 760-2667 05267781001 Rabbit Polyclonal Pancreas Cytoplasmic 50 tests Pancreas Description Somatostatin Rabbit Polyclonal Primary Antibody is a useful marker of D cells of pancreatic islet cells. D-cell identification can be used to identify hyperplasia of the pancreatic islets as well as islet cell tumours such as somatostatinomas. Somatostatin can also be found in gastro-intestinal and broncho-pulmonary endocrine cells, thymic endocrine cells and thyroid C cells. Somatostatin suppresses gastric acid secretion, gall bladder contractions and pancreatic enzyme secretion. References 1. Krejs GJ, et al., N. Eng J Med. 301:285-292, 1979. 2. Somers G, et al., Gastroenterology. 85:1192-1198, 1983. 3. Erlandsen SL, et al., Williams and Wilkins, Baltimore. 140-155, 1980. 4. Friesen SR, et al., N Eng J Med. 306:580-590, 1982. 5. Tzaneva MA, et al., Acta Histochem. 105(2):191-201, 2003. 6. Quartu M, et al., J Chem Neuroanat. 6(2):79-99, 1993. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 167 IHC & ISH | Primary Antibodies by alphabetical listing HOME Spectrin (RBC2/3D5) Part Number Type Control Localisation Quantity Isotype <PREV 760-4274 05269377001 Mouse Monoclonal Bone Marrow Membranous 50 tests IgG2b/K Bone Marrow, red blood cell precursors Description Spectrin is a cytoskeletal protein which is found in muscles, red blood cells and red blood cell precursors. Spectrin (RBC2/3D5) Mouse Monoclonal Primary Antibody is useful in the diagnosis of erythroid leukaemias. References 4. Terada N, et al., J Anat. 190(3):397-404, 1997. 1. Sadahira Y, et al., J Clin Pathol. 52(12):919-21, 1999. 2. Nehls V, et al., Am J Pathol. 142(5):1565-73, 1993. 3. Muller M, et al., J Vet Med A Physiol Pathol Clin Med. 48(1):51-7, 2001 SV40 (Simian Virus 40) (MRQ-4) Part Number Type Control Localisation Quantity Isotype 760-4449 05973775001 Mouse Monoclonal SV80 or SV-T2 cells, SV40 infected tissue Nuclear 50 tests IgG1 Brain Description SV40, Simian Virus 40 is a polyomavirus that is found in both monkeys and humans. Like other polyomaviruses, SV40 is a DNA virus that has the potential to cause tumours. SV40 is believed to suppress the transcriptional properties of tumour-suppressing p53 in humans through the SV40 large T-antigen and SV40 small T-antigen. It is generally assumed that large T-antigen is the major protein involved in neoplastic processes and the large T-antigen predominantly exerts its effect through deregulation of tumour suppressor p53, which is responsible for initiating regulated cell death (apoptosis) or cell cycle arrest when a cell is damaged. A mutated p53 gene may contribute to uncontrolled cellular proliferation, leading to a tumour. The hypothesis that SV40 might cause cancer in human has been a particularly controversial area of research. Some research has suggested that SV40 is associated with brain tumours, bone cancers, non-Hodgkin’s lymphoma and malignant mesothelioma. SV40 may act as a cocarcinogen with crocidolite to cause mesothelioma. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 168 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME Synaptophysin NEW (MRQ-40) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-4595 06433324001 Rabbit Monoclonal Pancreatic Islet Cells Cytoplasmic 50 tests IgG1 Lung small cell carcinoma Description Synaptophysin (MRQ-40) Rabbit Monoclonal Primary Antibody is used as an aid in the identification of neuroendocrine neoplasms within the context of an antibody panel, the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist. References 1. Navone, F et al. J Cell Biol 103:2511-2527, 1986. 2. Wiedenmann, B et al. Cell. 41:1017-1028, 1985. 3. Kayser, K et al. Path Res Pract. 183:412-417, 1988. 4. Son, EI et al. Pathol Int. 53(2):67-73, 2003. 5. Conner, MG et al. Ann Diagn Pathol. 6(6):345-8, 2002. T-bet NEW (MRQ-46) Part Number Type Control Localisation Quantity Isotype 6. Lyda, MH et al. Hum Pathol. 31(8):980-7, 2000. 7. Skacel, M et al. Appl Immunohistochem Mol Morphol. 8(3):302-9, 2000. 8. Morrison, CD et al. Semin Diagn Pathol. 17(3):204-15, 2000. 9. Kamisawa, T et al. Pathol Res Pract. 192(9):901-8, 1996. 760-4598 06433391001 Rabbit Monoclonal Tonsil, Hairy Cell Leukaemia Nuclear 50 tests IgG1 Hairy cell leukaemia Description T-bet is used as an aid in the differentiation of hairy cell leukaemia, Hodgkin’s disease and precursor B-cell lymphoblastic leukaemia/ lymphoblastic lymphoma within the context of an antibody panel, the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist. References 1. Szabo, SJ et al. Cell. 100(6):665-69, 2000. 2. Zhang, WX et al. Genomics. 70(1):41-8, 2001. 3. Johrens, K et al. Am J Surg Pathol. 31(8):1181-1185, 2007. 4. Atayar, C et al. Am J Pathol. 166:127-134, 2005. 5. Dorfman, DM et al. Am J Clin Pathol. 122:292-297, 2004. 6. Harashima, A et al. Leuk Res. 29(7):841-8, 2005. 7. Marafioti, T et al. Am J Pathol. 162:861-871, 2003. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 169 IHC & ISH | Primary Antibodies by alphabetical listing HOME TAG-72 (B72.3) Part Number Type Control Localisation Quantity Isotype <PREV 760-2669 05267803001 Mouse Monoclonal Breast Carcinoma Cytoplasmic 50 tests IgG1/K Breast adenocarcinoma Description TAG-72 (B72.3) Mouse Monoclonal Primary Antibody recognises a high molecular weight glycoprotein called TAG-72 that is present in human adenocarcinomas and in lesser amounts, non-neoplastic tissues. It has also been found to be useful to distinguish between mesothelioma and adenocarcinoma, however, false positive reactions can occur so results must be interpreted with the utmost caution. References 1. Thor A, et al., Cancer Res. 46:3118, 1986. 2. Schlom J, et al., Tumourmarker Oncology. 2:3, 1987. 3. Johnston WW, et al., Hum Pathol. 17:501-513, 1986. 4. Lundy J, et al., Ann Aurg. 203:399-402, 1986. 5. Kline TS, et al., Cancer. 63:2253-2256, 1989. 6. Chhieng DC, et al., Hum Pathol. 34(10):1016-21, 2003, 7. Ordonez NG, et al., Am J Surg Pathol. 22(10):1203-14, 1998. TdT (Terminal Deoxynucleotidyl Transferase) (polyclonal) Part Number Type Control Localisation Quantity 760-2670 05267811001 Rabbit Polyclonal TdT Positive Lymphomas, Thymus Nuclear 50 tests Thymus, cortical thymocytes Description Terminal Deoxynucleotidyl Transferase (TdT) Rabbit Polyclonal Primary Antibody labels normal cortical thymocytes and primitive lymphocytes. TdT antibody detects an enzyme found in the nucleus of normal hematopoietic cells, normal cortical thymocytes and in the cytoplasm of megakaryocytes of the bone marrow. TdT expression is seen in over 90% of acute lymphoblastic lymphoma/leukaemia cases with the exception of pre-B-Cell ALL. TdT expression is not seen in normal mature T or B lymphocytes. TdT antibody is positive for approximately one third of all cases of chronic myeloid leukaemia, making it a good indicator of better response to chemotherapy. References 1. Elias JM, et al., TdT. A Practical Approach to Diagnosis, ASCP Press, 3. Orazi A, et al., Mod Pathol. 7(5):582-6, 1994. 4. Suzumiya J, et al., J Pathol. 182(1):86-91, 1997. Chicago 1990; 312-316. 2. Arber DA, et al., Am.J Clin Pathol. 106(4):462-8, 1996. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 170 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> Thymidine Phosphorylase, CONFIRM (P-GF.44C) Part Number Type Control Localisation Quantity Isotype 790-4454 05976502001 Mouse Monoclonal Astrocytes in Normal Brain, Lymphocytes in Spleen Nuclear, Cytoplasmic 50 tests IgG1 Breast carcinoma Description CONFIRM Thymidine Phosphorylase (P-GF.44C) Mouse Monoclonal Primary Antibody recognises human thymidine phosphorylase, an angiogenic factor, expressed in varying levels by macrophages, stromal cells, glial cells and some epithelial cells. Thymidine phosphorylase shows a cytoplasmic and/or nuclear location. This antibody exhibits a nuclear and/or cytoplasmic staining pattern and may be used to aid in the detection of thymidine phosphorylase in carcinoma of the breast, oesophagus, stomach, colon and rectum, pancreas, head and neck, ovaries and lung. References 1. Fox SB, et al., Biochemistry. 20:3615-3621, 1981. 2. Haraguchi M, et al., Biochem Pharmacol. 74:1555-1567, 2007. 3. Desgranges C, et al., Biochem Biophys Acta. 654:211-218, 1981. Thyroglobulin (2H11+6E1) Part Number Type Control Localisation Quantity Isotype 4. Yoshimura A, et al., Biochem Biophys Acta. 1034:107-113. 1990. 5. De Bruin M, et al., Cancer Ther. 4:99-124, 2006. 760-2671 05267820001 Mouse Monoclonal Thyroid Cytoplasmic 50 tests IgG1 Follicular carcinoma of thyroid Description Thyroglobulin (2H11+6E1) Mouse Monoclonal Primary Antibody reacts with human thyroglobulin as demonstrated by a single band of immunoblotting in a lysate of human thyroid tissue. The vast majority of follicular carcinomas of the thyroid will give positive immunoreactivity for thyroglobulin even though sometimes only focal. Poorly differentiated carcinomas of the thyroid are frequently thyroglobulin negative. Adenocarcinomas of other than thyroid origin do not react with this antibody. References 1. Bellet D, et al., J Clin Endocrin Metab. 56:530-533, 1983. 2. Heffess CS, et al., Cancer. 95(9):1869-78, 2002. 3. Bejarano PA, et al., Appl Immunohistochem Mol Morphol. 8(3): 189-94, 2000. 4. Judkins AR, et al., Hum Pathol. 30(11):1373-6, 1999. 5. Hammer SP, et al., Hum Pathol. 29(12):1393-402, 1998. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 171 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV Thyroid Stimulating Hormone (TSH) (polyclonal) Part Number Type Control Localisation Quantity 760-2709 05268184001 Rabbit Polyclonal Normal Pituitary Cytoplasmic 50 tests Pituitary Description Thyroid Stimulating Hormone (TSH) Rabbit Polyclonal Primary Antibody is a useful marker in classification of pituitary tumours and the study of pituitary disease. It reacts with TSH-producing cells (thyrotrophs). TSH is a pituitary hormone of 28 kD, which stimulates thyroid growth and production of thyroid hormones. References 1. Batanero E, et al., Brain Behav Immun. 6(3):249-64, 1992. 2. Kovalic JJ, et al., J Neurooncol. 16(3):227-32, 1993. 3. Gessl A, et al., J Clin Endocrinol Metab. 79(4):1128-34, 1994. 4. Sanno N, et al., J Clin Endocrinol Metab. 80(8):2518-22, 1995. 5. La Rosa S, et al., Virchows Arch. 437(3):264-9, 2000. Thyroid Transcription Factor-1 (TTF-1), CONFIRM (8G7G3/1) Part Number Type Control Localisation Quantity Isotype 790-4398 05479312001 Mouse Monoclonal Lung Carcinoma, Lung, Thyroid Nuclear 50 tests IgG1 Description TTF-1 is a 38 kD nuclear protein member of the family of homeodomain transcription factors. Exclusive expression in epithelial cells of the thyroid gland and lung allows TTF-1 to be a useful antibody for the classification of tumours arising in these organs. In context with other data, TTF-1 becomes useful in the investigation of metastatic adenocarcinomas of an unknown origin. TTF-1 demonstrates an intranuclear staining pattern and normal thyroid gland follicle cells and lung parenchymal alveolar lining cells serve as excellent tissue internal controls. References 1. Dongfeng T, et al., Human Pathology. 34:597-604, 2003. 2. Ordonez N, American J of Surgical Pathol. 25:363-372, 2001. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 172 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME <PREV NEXT> Topoisomerase IIa, CONFIRM (JS5B4) Part Number Type Control Localisation Quantity 790-4371 05479339001 Rabbit Monoclonal Tonsil, Spleen Nuclear 50 tests Breast carcinoma Description CONFIRM Topoisomerase IIα (JS5B4) Rabbit Monoclonal Primary Antibody is designed to qualitatively detect the presence of topoisomerase IIα expressing cells. During the cell cycle, topoisomerase IIα is expressed in the G1, S, G2 and M phase but is absent in the G0 (quiescent) phase. Assessment of the proportion of positive staining cells for topoisomerase IIα may aid in evaluation of the proliferative activity of normal and/or neoplastic tissue. References 1. Kreipe H, et al., AM J Pathol. 142:3-9, 1993 2. Rudolph P, et al., AM J Pathol. 147:1615-25, 1995. 3. Kreipe H, et al., AM J Pathol. 142:651-657, 1993. 4. Kellner U, et al., J of Histochem and Cytochem. 45:251-264, 1997. TRAcP (Tartrate-Resistant Acid Phosphatase) (9C5) Part Number Type Control Localisation Quantity Isotype 760-4275 05269385001 Mouse Monoclonal Hairy Cell Leukaemia Cytoplasmic 50 tests IgG2b Bone marrow Description The histochemical identification of hairy cell leukaemia via tartrate-resistant acid phosphatase assay has been a standard for over two decades. TRAcP (9C5) Mouse Monoclonal Primary Antibody labels the cells of hairy cell leukaemia (HCL) with a high degree of sensitivity and specificity. Other cells stained with this antibody are tissue macrophages and osteoclasts, which also express abundant TRAcP activity. References 1. Janckila AJ, et al., Blood. 85(10):2839-44, 1995. 2. Yaziji H, et al., Am. J Clin Pathol. 104(4):397-402, 1995. 3. Janckila AJ, et al., J Histochem Cytochem. 44(3):235-44, 1996. 4. Janckila AJ, et al., Hybridoma. 16(2):175-82, 1997. 5. Hoyer JD, et al., Am J Clin Pathol. 108(3):308-15, 1997. 6. Janckila AJ, et al., Biotech Histochem. 73(6):316-24, 1998. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 173 IHC & ISH | Primary Antibodies by alphabetical listing HOME Tryptase (G3) Part Number Type Control Localisation Quantity Isotype <PREV 760-4276 05269393001 Mouse Monoclonal Mast Cell-Containing Tissue Cytoplasmic 50 tests IgG1 Cervix Description Tryptases constitute a subfamily of trypsin-like proteinases, stored in the mast cell secretory granules and basophils. Upon cellular activation, these enzymes are released into the extracellular environment. Tryptase (G3) Mouse Monoclonal Primary Antibody is a good marker for mast cells, basophils and their derivatives. References 1. Fiorucci L, et al., Cell Mol Life Sci. 61(11):1278-95, 2004. 2. Li CY, et al., Leuk Res. 25(7):537-41, 2001. 3. Jordan JH, et al., Hum Pathol. 32(5):545-52, 2001. 4. Gordon LK, et al., Clin Immunol. 94(1):42-50, 2000. 5. Aoki M, et al., Int Arch Allergy Immunol. 130(3):216-23, 2003. Tyrosinase, CONFIRM (T311) Part Number Type Control Localisation Quantity Isotype 790-4365 05479347001 Mouse Monoclonal Melanoma Cytoplasmic 50 tests IgG2a Melanoma, with area showing normal melanoctyes Description Tyrosinase is an enzyme involved in the production of melanin pigments. This enzyme catalyses the formation of melanin within the cells and thus becomes a useful marker for the presence of melanocytes and melanosomes. As a marker of melanocytic lineage, tyrosinase is localised to melanocytes which can be found on the dermal/epidermal junction of normal skin, but is not detected in other normal cells. Expression of tyrosinase is also found in melanocytic lesions including benign nevi and the majority of primary and metastatic malignant melanomas and not in non-melanocytic tumour types. References 1. Chen Y, et al., Proc Natl Acad Sci USA. 92:8125-8129, 1995. 2. Jungbluth A, et al., Pathol Res Pract. 196:235-242, 2000. 3. Clarkson K, et al., J Clin Pathol. 54:196-200, 2001. 4. Kwon B, J of Invest Dermatol. 100:134S-140S, 1993. 5. Hofbauer G, et al., J Cutan Pathol. 25:204-209, 1998. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 174 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME Uroplakin III NEW (SP73) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-4533 06419232001 Rabbit Monoclonal Bladder Membranous, Cytoplasmic 50 tests IgG1 Description Uroplakins (UPs) are a family of transmembrane proteins (UPs Ia, Ib, II and III) that are specific differentiation products of urothelial cells. In non-neoplastic mammalian urothelium, UPs are expressed in the luminal surface plasmalemma of superficial (umbrella) cells, forming complexes of 16-nm crystalline particles. Moll, et al. reported that UPIII was detectable immunohistochemically in 29 of 55 primary (53%) and 23 of 35 metastatic (66%) urothelial carcinomas, whereas many non-urothelial carcinomas were UPIII-negative. The authors concluded that UPIII should be a valuable marker, especially for the specific identification of urothelial carcinomas in patients with metastases of unknown primary site. References 1. Angel CE, et al., Blood. 113:1257-67, 2009. 2. Moll R et al., Am J Pathol. 147:1383-1397, 1995. Villin (CWWB1) Part Number Type Control Localisation Quantity Isotype 3. Olsburgh J, et al., J Pathol. 199: 41-49, 2003. 4. Ohtsuka Y, et. al., BJU Int. 97:1322-6, 2006. 760-4277 05269407001 Mouse Monoclonal Small Bowel Mucosa, Colonic Mucosa Cytoplasmic, Membranous 50 tests IgG1 Colon Description Villin is a 95kD glycoprotein of microvilli associated with rootlet formation in gastro-intestinal mucosal epithelium. Villin (CWWB1) Mouse Monoclonal Primary Antibody labels the brush border area in the gastro-intestinal mucosal epithelium. This antibody has been useful in differentiating gastro-intestinal adenocarcinoma, neuroendocrine carcinomas and ovarian adenocarcinomas from adenocarcinomas from other organs. Also labelled by this antibody are Merkel cells of the skin. References 1. Werling RW, et al., Am J Surg Path. 27(3):303-310, 2003. 2. Tan J, et al., Hum Pathol. 29:390-396, 1998. 3. Goldstein NS, et al., Am J Clin Pathol. 116:319-325, 2001. 4. Lau SK, et al., Hum Pathol. 33:1175-1181, 2002. 5. Tamboli P, et al., Arch Pathol Lab Med. 126:1057-1063, 2002. 6. Zhang PJ, et al., Arch Pathol Lab Med. 123:812-816, 1999. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 175 IHC & ISH | Primary Antibodies by alphabetical listing HOME Vimentin, CONFIRM (V9) Part Number Type Control Localisation Quantity Isotype <PREV 790-2917 05278139001 Mouse Monoclonal Lymph Node, Skin Cytoplasmic 50 tests IgG/K Tonsil Description Vimentin antigen is expressed in endothelial cells, fibroblasts, smooth muscle cells and lymphoid cells. A number of tumours coexpress vimentin and cytokeratin, for example thyroid carcinomas, pleomorphic adenomas of the salivary glands, ovarian carcinomas and some renal carcinomas. Co-expression of desmin and vimentin has been reported in a number of soft tissue tumours, for example rhabdomyosarcomas, leiomyosarcomas and alveolar soft tissue sarcomas. References 1. Sheibani K, et al., Am J Surg Pathol. 12(1): 28-34, 1988. 2. Azumi N, et al., Am J Clin Pathol. 88(3): 286-296, 1987. 3. Benjamin E, et al., J Pathol. 152(4): 253-263, 1987. Vimentin, CONFIRM (Vim 3B4) Part Number Type Control Localisation Quantity Isotype 4. Miettinen M, et al., Arch Dermatol. 121(6): 736-741, 1985. 5. Osborn M, et al., Eur J Cell Biol. 34(1): 137-143, 1984. 760-2512 05266998001 Mouse Monoclonal Intestine, Liver Cytoplasmic 50 tests IgG2a Tonsil Description Vimentin is the major and usually only intermediate filament in a variety of non-muscle mesenchymal cells, including all fibroblastic cells, endothelial cells, lipocytes, Schwann cells and macrophages. The pattern of expression of intermediate filaments may be used as a device to aid in the classification of undifferentiated neoplasms. Vimentin is expressed in most malignant melanomas, either in the primary site or in metastatic foci. References 1. Weins B, Progen Biotechnik GmbH, Heidelberg, Germany, 1994. 2. Azumi N, et al., Am J Clin Pathol. 88(3): 286 296, 1987. 3. True LD, J.B. Lippincott Company, Philadelphia. 1990. 4. Taylor RT, et al., WB Saunders Company, Philadelphia. 1994. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 176 NEXT> Primary Antibodies by alphabetical listing | IHC & ISH HOME WT1 (6F-H2) Part Number Type Control Localisation Quantity Isotype <PREV NEXT> 760-4397 05435706001 Mouse Monoclonal Malignant Mesothelioma, Kidney, Testicle Nuclear 50 tests IgG1/K Mesothelioma Description WT1 is a suppressor gene located on chromosome 11p13. Wilms’ Tumour Protein (WT1) has been identified in proliferative mesothelial cells, malignant mesothelioma, ovarian cystadenocarcinoma, gonadoblastoma, nephroblastoma and desmoplastic small round cell tumour. Lung adenocarcinomas rarely stain positive with this antibody. References 1. Ordonez NG, Am J Surg Pathol. 24(4):598-606, 2000. 2. Ordonez NG, Am J Surg Pathol. 22(11):1314-1327, 1998. 3. Charles AK, et al., Histopathology. 30(4):312-4, 1997. 4. Hussong J, et al., Mod Pathol. 10(11):1101-5, 1997. ZAP-70 (2F3.2) Part Number Type Control Localisation Quantity Isotype 5. Barnoud R, et al., Am J Surg Pathol. 24(6):830-6, 2000. 6. Lucas DR, et al., Histopathology. 42(3):270-9, 2003. 7. Jimenez RE, et al., Am J Surg Pathol. 26(3):320-7, 2002. 8. Roberts F, et al., J Clin Pathol. 54(10):766-70, 2001. 760-4278 05269415001 Mouse Monoclonal Chronic Lymphocytic Leukaemia, Tonsil, Lymph Node Cytoplasmic 50 tests IgG2a Chronic lymphocytic leukaemia Description ZAP-70 is a 70 kD protein tyrosine kinase found in T cells and natural killer cells. Control of this protein translation is via the IgVH gene. ZAP-70 protein is expressed in leukaemic cells of approximately 25% of Chronic Lymphocytic Leukaemia (CLL) cases as well. ZAP-70 expression is an excellent surrogate marker for the distinction between the Ig-mutated (ZAP-70 negative) and Ig-unmutated (ZAP-70 positive) CLL subtypes and can identify patient groups with divergent clinical courses. The ZAP-70 positive Ig-unmutated CLL cases have a poorer prognosis. References 1. Wiestner A, et al., Blood. 101(12):4944-4951, 2003. 2. Crespo M, et al., N Eng J Med. 348(18):1764-1775, 2003. 3. Chen L, et al., Blood. 100(13):4609-14, 2002. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 177 IHC & ISH | Primary Antibodies by alphabetical listing HOME <PREV We have partnered with Cell Marque Corporation to provide you with an extended menu of primary antibodies for immunohistochemistry. The table below identifies all of the antibodies that are manufactured by Cell Marque. α-1-Antichymotrypsin (ACT) α-1-Antitrypsin (AAT) α-Fetoprotein (AFP) Actin, Muscle Specific Actin, Smooth Muscle Adrenocorticotrophin (ACTH) Annexin A1 BCA-225 bcl-6 Beta-catenin BG8, Lewisy BOB.1 C3d C4d CA 125 CA 19-9 Calcitonin Caldesmon Calponin-1 CD1a CD2 CD14 CD21 (2G9) CD21 (EP3093) CD25 CD31 (JC-70) CD31 (1A10) CD34 CD45 CD45R CD56 (MRQ-42) CD57 CD61 CD63 CD71 CD74 CD-138/syndecan-1 CD163 CDX-2 CEA (CEA31) Collagen Type IV COX-2 (Cyclooxygenase 2) Cytokeratin (34bH11) Cytokeratin 8 & 18 Cytokeratin 14 Cytokeratin 19 DOG1 (SP31) E-Cadherin (EP700Y) Ep-CAM (Epithelial Specific Antigen) Factor VIII Related Antigen Factor XIIIa (AC-1A1) Factor XIIIa (EP3372) Fascin FSH (Follicle Stimulating Hormone) Galectin-3 Gastrin GCDFP-15 GFAP (Glial Fibrillary Acidic Protein) Glucagon GLUT-1 Glycophorin A Glypican-3 Granzyme B GH (Growth Hormone) Herpes Simplex Virus I Herpes Simplex Virus II HGAL HHV-8 (Human Herpes Virus Type 8) HSA (Hepatocyte Specific Antigen) Human Chorionic Gonadotropin (hCG) Human Placental Lactogen (hPL) IgA IgD IgG IgM Inhibin, alpha Insulin Ksp-Cadherin Luteinizing Hormone (LH) Lysozyme Macrophage Mammaglobin Melanoma Associated Antigen (KBA.62) Melanoma Associated Antigen (PNL2) Mesothelial Cell MLH1 (M1) MSH2 MUC2 MUC5AC MUC6 MUM1 Myeloperoxidase Myogenin Myoglobin Myosin, Smooth Muscle Napsin A Neurofilament NGFR (Nerve Growth Factor Receptor) NSE (Neuron Specific Enolase) Oct-2 Oct-4 p21WAF1 p27kip1 Parathyroid Hormone (PTH) PD-1 The products that appear on this page are IVD (for in vitro diagnostic use). 178 Perforin PGP 9.5 Phosphohistone-H3 (PHH3) Placental Alkaline Phosphotase (PLAP) PMS2 Pneumocistis jiroveci (carinii) Podoplanin Prolactin PSAP (Prostatic Acid Phosphatase) Renal Cell Carcinoma (RCC) Smoothelin Somatostatin Spectrin SV40 Synaptophysin (MRQ-40) T-bet TAG-72 TdT (Terminal Deoxynucleotidyl Transferase) Thyroglobulin Thyroid Stimulating Hormone (TSH) TRAcP (Tartrate-Resistant Acid Phosphatase) Tryptase Uroplakin III Villin WT1 ZAP-70 NEXT> Immunofluorescence Antibodies HOME | IHC & ISH <PREV NEXT> Immunofluorescence Antibodies Albumin, FITC Part Number Type Control Species Quantity 760-2699 05268087001 Polyclonal Frozen, Diseased Skin or Diseased Renal Tissue Goat 50 tests Renal tubule basement membrane Description FITC anti-Albumin Primary Antibody is a goat-derived polyclonal antibody labelled with fluorescein and specifically directed against human albumin. This reagent should be used in conjunction with a panel of antibodies to aid in the identification of human albumin in target tissue (e.g. in the diagnosis of renal or dermal pathologies). FITC anti-Albumin is intended for laboratory use to qualitatively stain sections of frozen tissue on a VENTANA automated slide stainer. C1q, FITC Part Number Type Control Species Quantity 760-2688 05267994001 Polyclonal Frozen, Diseased Skin or Diseased Renal Tissue Goat 50 tests Lupus Nephritis Photo courtesy of Lois J. Arend, Ph.D., M.D., Dept. of Pathology and Laboratory Medicine, University of Cincinnati Medical Ctr. Description FITC anti-C1q (complement 1q) Primary Antibody is a goat-derived polyclonal antibody labelled with fluorescein and specifically directed against human C1q. This reagent should be used in conjunction with a panel of antibodies to aid in the identification of complement 1q in C1q target tissue (e.g. in the diagnosis of renal or dermal pathologies). FITC anti-C1q is intended for laboratory use to qualitatively stain sections of frozen tissue on a VENTANA automated slide stainer. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 179 IHC & ISH | Immunofluorescence Antibodies HOME C3, FITC Part Number Type Control Species Quantity <PREV 760-2686 05267978001 Polyclonal Frozen, Kidney or Skin from Lupus Cases Containing C3 Deposits Goat 50 tests Kidney lupus Description FITC anti-C3 (complement 3) Primary Antibody is a goat-derived polyclonal antibody labelled with fluorescein and specifically directed against human C3. This reagent should be used in conjunction with a panel of antibodies to aid in the identification of complement 3 in C3 target tissue (e.g. in the diagnosis of renal or dermal pathologies). FITC anti-C3 is intended for laboratory use to qualitatively stain sections of frozen tissue on a VENTANA automated slide stainer. C4, FITC Part Number Type Control Species Quantity 760-2687 05267986001 Polyclonal Frozen, Diseased Skin or Diseased Renal Tissue Sheep 50 tests Glomerulus Description FITC anti-C4 (complement 4) Primary Antibody is a sheep-derived polyclonal antibody labelled with fluorescein and specifically directed against human C4. This reagent should be used in conjunction with a panel of antibodies to aid in the identification of complement 4 in C4 target tissue (e.g. in the diagnosis of renal or dermal pathologies). FITC anti-C4 is intended for laboratory use to qualitatively stain sections of frozen tissue on a VENTANA automated slide stainer. Fibrinogen, FITC Part Number Type Control Species Quantity 760-2685 05267960001 Polyclonal Frozen, Placenta or Tissue Containing Clotted Blood Goat 50 tests Kidney , normal Description FITC anti-Fibrinogen Primary Antibody is a goat-derived polyclonal antibody labelled with fluorescein and specifically directed against human fibrinogen. This reagent should be used in conjunction with a panel of antibodies to aid in the identification of fibrinogen in target tissue (e.g. in the diagnosis of renal or dermal pathologies). FITC anti-Fibrinogen is intended for laboratory use to qualitatively stain sections of frozen tissue on a VENTANA automated slide stainer. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 180 NEXT> Immunofluorescence Antibodies HOME IgA, FITC Part Number Type Control Species Quantity | IHC & ISH <PREV NEXT> 760-2681 05267927001 Polyclonal Frozen, Tonsil or Lymph Node Goat 50 tests IgA Nephropathy Photo courtesy of Lois J. Arend, Ph.D., M.D., Dept. of Pathology and Laboratory Medicine, University of Cincinnati Medical Ctr. Description FITC anti-IgA (immunoglobulin A) Primary Antibody is a goat-derived polyclonal antibody labelled with fluorescein and specifically directed against human IgA. This reagent should be used in conjunction with a panel of antibodies to aid in the identification of immunoglobulin A in IgA target tissue (e.g. in the diagnosis of renal or dermal pathologies). FITC anti-IgA is intended for laboratory use to qualitatively stain sections of frozen tissue on a VENTANA automated slide stainer. IgG, FITC Part Number Type Control Species Quantity 760-2680 05267919001 Polyclonal Frozen, Tonsil or Lymph Node Clotted Blood Goat 50 tests Membraneous Glomerulopthy Photo courtesy of Lois J. Arend, Ph.D., M.D., Dept. of Pathology and Laboratory Medicine, University of Cincinnati Medical Ctr. Description FITC anti-IgG (immunoglobulin G) Primary Antibody is a goat-derived polyclonal antibody labelled with fluorescein and specifically directed against human IgG. This reagent should be used in conjunction with a panel of antibodies to aid in the identification of immunoglobulin G in IgG target tissue (e.g. in the diagnosis of renal or dermal pathologies). FITC anti-IgG is intended for laboratory use to qualitatively stain sections of frozen tissue on a VENTANA automated slide stainer. IgM, FITC Part Number Type Control Species Quantity 760-2682 05267935001 Polyclonal Frozen, Tonsil or Lymph Node Goat 50 tests Plasma cells Description FITC anti-IgM (immunoglobulin M) Primary Antibody is a goat-derived polyclonal antibody labelled with flurescein and specifically directed against human IgM. This reagent should be used in conjuction with a panel of antibodies to aid in the identification of immunoglobulin M in IgM target tissue (e.g. in the diagnosis of renal or dermal pathologies). FITC anti-IgM is intended for laboratory use to qualitatively stain sections of frozen tissue on a VENTANA automated slide stainer. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 181 IHC & ISH | Immunofluorescence Antibodies HOME Kappa, FITC Part Number Type Control Species Quantity <PREV 760-2683 05267943001 Polyclonal Frozen, Tonsil or Lymph Node Clotted Blood Goat 50 tests Description FITC anti-Kappa Primary Antibody is a goat-derived polyclonal antibody labelled with fluorescein and specifically directed against human kappa immunoglobulin light chains. This reagent should be used in conjunction with a panel of antibodies to aid in the identification of kappa in target tissue (e.g. in the diagnosis of renal or dermal pathologies). FITC anti-Kappa is intended for laboratory use to qualitatively stain sections of frozen tissue on a VENTANA automated slide stainer. Lambda, FITC Part Number Type Control Species Quantity 760-2684 05267951001 Polyclonal Frozen, Tonsil or Lymph Node Burro 50 tests Photo courtesy of Lois J. Arend, Ph.D., M.D., Dept. of Pathology and Laboratory Medicine, University of Cincinnati Medical Ctr. Description FITC anti-Lambda Primary Antibody is a burro-derived polyclonal antibody labelled with fluorescein and specifically directed against human lambda light chains. This reagent should be used in conjunction with a panel of antibodies to aid in the identification of lambda light chains in target tissue (e.g. in the diagnosis of renal or dermal pathologies). FITC anti-Lambda is intended for laboratory use to qualitatively stain sections of frozen tissue on a VENTANA automated slide stainer. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 182 NEXT> Research Antibodies HOME | IHC & ISH <PREV NEXT> Research Antibodies Hepatitis B Virus Core Antigen (Polyclonal) Part Number Type Status Quantity 760-2646 05267579001 Rabbit Polyclonal RUO 50 tests Description Hepatitis B Core Antigen Rabbit Polyclonal Primary Antibody labels cell nuclei infected with Hepatitis B virus, a common cause of Hepatitis leading to cirrhosis. Hepatitis B is the second most common cause of parenterally transmitted Hepatitis. Hepatitis B Virus Surface Antigen (S1-210) Part Number Type Status Quantity 760-2647 05267587001 Mouse Monoclonal RUO 50 tests Description Hepatitis B Surface Antigen Mouse Monoclonal Primary Antibody labels the cell cytoplasm infected with Hepatitis B virus, a common cause of Hepatitis leading to cirrhosis. Hepatitis B is the second most common cause of parenterally transmitted Hepatitis. Ventana part number in black, Roche item number in blue. The products that appear on this page are RUO (for research use only). www.ventana.com | www.roche.com 183 IHC & ISH | Research Antibodies HOME <PREV Prostate Specific Antigen (PSA) (ER-PR8) Part Number Type Status Quantity 760-4271 05269334001 Mouse Monoclonal RUO 50 tests Mesothelioma Description PSA is an antigen present in prostatic tissue and in the majority of prostatic carcinomas. This antibody recognises primary and metastatic prostatic neoplasms and rarely in tumours of non-prostatic origin. These include breast and a minority of salivary gland tumours. The antigen is a 33-34 kD glycoprotein that is restricted to epithelial cells of the prostate. An immunohistochemical study showed more than 95% of prostatic carcinomas stained with anti-PSA8. PSA is demonstrable in the cytoplasm of acinar and ductal cells of normal or malignant prostate tissue. References 1. Gallee MPW, et al., Prostate. 9:33-45, 1986. 2. Nadji M, et al., Cancer. 48(5):1229-1232, 1981. 3. Genega EM, et al., Mod Pathol. 13(11):1186-91, 2000. 4. Green LK, et al., Hum Pathol. 22(3):242-6, 1991. 5. van Krieken JH, et al., Am J Surg Pathol. 17(4):410-4, 1993. Ventana part number in black, Roche item number in blue. The products that appear on this page are RUO (for research use only). 184 NEXT> Molecular Probes | IHC & ISH Molecular Probes HOME <PREV NEXT> INFORM HER2 Dual ISH DNA Probe Cocktail Assay Product INFORM HER2 Dual ISH DNA Probe Cocktail HybReady ultraView SISH DNP Detection Kit ultraView Red ISH DIG Detection Kit ultraView Siler Wash II HER2 Dual ISH 3-in-1 Xenograft Slides Part Number 800-4422 780-4409 800-098 800-505 780-003 783-4332 05899826001 05917557001 05907136001 05907128001 05446724001 05276101001 Quantity 25 tests 250 dispenses 100 tests 100 tests 2L 10 slides Description The INFORM HER2 Dual ISH DNA Probe Cocktail is designed to quantitatively detect amplification by light microscopy of the HER2 gene via two colour chromogenic in situ hybridisation (ISH) in formalin-fixed, paraffin-embedded tissue specimens of human breast cancer and gastric cancer, including the gastro-oesophagal junction, following staining on VENTANA automated slide stainers. The INFORM HER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. This product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information and proper controls. HER2 clusters and Chr17 60X, amplified HER2 and Chr17 60X, non-amplified References 1. Gschwind A, Fischer OM, Ullrich A. The discovery of receptor tyrosine kinases: target for cancer therapy. Nat Rev Cancer 2004;4;361-370. 2. Muleris M, et al. Assignment of v-erb-b2 avian erythroblastic leukemic viral oncogene homolog 2 (ERBB2) to human chromosome band 17121.1 by in situ hybridisation. Cytogenet Cell Genet. 1997;76:34-5. 3. Coussens L, Yang-Feng TL, Liao YC, Chen E, Gray A, McGrath J, et al. Tyrosine kinase receptor with extensive homology to EGF receptor shares chromosomal location with neu oncogene. Science. 1985;230:1132-1139. 4. Slamon DJ, Godolphin W, Jones LA, et al. Studies of the HER- 2/neu proto-oncogene in human breast and ovarian cancer. Science. 1989;244:707-712. 5. Slamon DJ, Clark GM, Wong SG, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER- 2/neu oncogene. Science 1987;235:177-182. 6. Narita M, Nakao K, Ogino N, et al. Independent prognostic factors in breast cancer patients. Am J Surg 1998;175:73-75. 7. O’Reilly SM, Barnes DM, Camplejohn RS, et al. The relationship between c-erbB-2 expression, S-phase fraction and prognosis in breast cancer. Br J Cancer. 1991;63:444-446. 8. Pegram MD, Finn RS, Arzoo K, et al. The effect of HER-2/neu overexpression on chemotherapeutic drug sensitivity in human breast and ovarian cancer cells. Oncogene. 1997;15:537-547. 9. Press MF, Pike MC, Chazin VR, et al. HER-2/neu expression in nodenegative breast cancer: Direct tissue quantitation by computerised image analysis and association of overexpression with increased risk of recurrent disease. Cancer Res. 1993;53:4960-4970. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 185 IHC & ISH | Molecular Probes HOME <PREV VENTANA HER2 DNA Probe Assay Product VENTANA HER2 DNA Probe INFORM Chromosome 17 Probe Rabbit Anti-DNP ultraView SISH Detection Kit ultraView Alkaline Phosphatase (AP) Red ISH Detection Kit ultraView Siler Wash II HER2 3-in-1 Xenograft Control Slides Interpretation Guide Part Number Quantity 780-4495 05999588001 50 tests 780-4331 05273412001 50 tests 780-4335 05273447001 100 tests 780-001 05271967001 100 tests 800-504 05278929001 100 tests 780-003 05276101001 2L 783-4332 05276101001 10 slides Please contact your sales representative Description VENTANA HER2 DNA Probe is designed to detect amplification of the HER2 gene via chromogenic silver or dual colour in situ hybridisation in formalin-fixed, paraffin-embedded breast and gastric cancer, including the gastro-oesophageal junction, tissue specimens following staining on VENTANA automated slide stainers using light microscopy. VENTANA HER2 DNA Probe spans approximately 200,000 base pairs of the HER2 gene (also known as ERBB2 and NEU). The DNP labelled probe is designed to detect amplification of the HER2 gene, which occurs in a percentage of patients diagnosed with invasive breast carcinoma.1 HER2/neu is a member of the family of four transmembrane receptor tyrosine kinases that mediate the growth, differentiation and survival of cells. 2,3 The HER2 gene is located on Chromosome 17 and encodes the HER2 protein. 3,4 Overexpression of the HER2 protein, amplification of the HER2 gene or both occur in approximately 15 to 25 percent of breast cancers and are associated with aggressive tumour behaviour.5,1 Recently, amplification of HER2 has been shown to occur in approximately 17% of invasive gastric tumours.6 Additionally, a high correlation has been shown between HER2 IHC and ISH diagnostic assays on gastric tumour tissue. The scoring criteria for HER2 IHC and ISH assays was previously published and differs slightly from the breast tumour criteria.7 Therefore, a knowledge of HER2 gene and/ or protein status in invasive breast or gastric cancer patients enables clinicians to make more informed decisions to improve the overall management of their cancer patients. VENTANA HER2 DNA Probe is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. VENTANA Chromosome 17 Probe is designed to detect ploidy status of Chromosome 17 via chromogenic silver or dual colour in situ hybridisation in formalin-fixed, paraffin-embedded human breast or gastric tissue specimens following staining on a VENTANA automated slide stainer. The determination of the genomic status of chromosome 17 (i.e., ploidy) plays a role in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. The VENTANA Chromosome 17 Probe is a 42 base-pair synthetic oligonucleotide designed to “paint” the centromeric region of human Chromosome 17. The oligonucleotide probe also has a 5’ non-binding AT-rich tail that contains DNP molecules detectable with anti-DNP antibodies. References 1. Slamon DJ, Godolphin W, Jones LA, et al. Studies of the HER-2/ neu proto-ongene in human breast and ovarian cancer. Science 1989;244:707-712. 2. Gschwind A, Fischer OM, Ullrich A. The discovery of receptor tyrosine kinases: target for cancer therapy. Nat Rev Cancer 2004;4;361-370. 3. Muleris M, et al., Assignment of v-erb-b2 avian erythroblastic leukemic viral oncogene homolog 2 (ERBB2) to human chromosome band 17121.1 by in situ hybridisation. Cytogenet Cell Genet 1997; 76:34-5. 4. Coussens L, Yang-Feng TL, Liao Y-C, chen E, Gray A, McGrath et al. Tyrosine kinase receptor with extensive homology to EGF receptor shares chromosomal location with neu oncogene. Science 1985;230:1132-1139. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 186 NEXT> Molecular Probes | IHC & ISH HOME <PREV NEXT> INFORM EGFR Probe Assay Product INFORM EGFR DNA Probe INFORM Chromosome 7 Probe Rabbit Anti-DNP ultraView SISH Detection Kit ultraView Alkaline Phosphatase (AP) Red ISH Detection Kit ultraView Siler Wash II EGFR ISH Xenograft Control Slides Interpretation Guide Part Number 800-4343 05278902001 800-4342 05278899001 780-4335 05273447001 780-001 05271967001 800-504 05278929001 780-003 05276101001 783-4343 05276110001 Please contact your sales representative EGFR Case 1: Single staining (silver) of EGFR and Chromosome 7 Chromosome 7 Quantity 25 tests 25 tests 100 tests 100 tests 100 tests 2L 10 slides EGFR/Chromosome 7 Case 2: Dual staining of EGFR (Silver) and Chromosome 7 (Red) Description The INFORM EGFR DNA Probe is designed to quantitatively detect EGFR genomic gain via chromogenic silver in situ hybridisation (SISH) in formalin-fixed, paraffin-embedded human non-small cell lung cancer (NSCLC) specimens following staining on VENTANA automated slidestaining instruments using light microscopy. EGFR gene status is reported as an absolute copy number as well as a function of the ratio of the average number of copies of the EGFR gene to the average number of copies of Chromosome 7 (Chr7) per cell. Visualisation of the EGFR gene and Chromosome 7 centromere is either performed on separate slides using the Silver in situ Hybridisation (SISH) detection kit, or on one single slide, with a dual colour staining technique using SISH detection kit for the EGFR gene and Alkaline Phosphatese (AP) Red ISH detection kit for Chromosome 7 centromere. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 187 IHC & ISH | Molecular Probes HOME <PREV INFORM IGF1R Probe Assay Product INFORM IGF1R DNA Probe INFORM Chromosome 15 DIG Probe HybReady ultraView SISH DNP ultraView Red ISH DIG Detection Kit ultraView Siler Wash II IGF1R ISH Xenograft Slides Interpretation Guide Case 1: Not amplified for IGF1R (IGF1R in silver and Chr15 in red, 60X) Part Number 800-4458 05994934001 800-4459 05994926001 780-4409 05917557001 800-098 05907136001 800-505 05907128001 780-003 05276101001 783-4458 05994977001 Please contact your sales representative Quantity 25 tests 25 tests 250 dispenses 100 tests 100 tests 2L 10 slides Case 2: Amplified for IGF1R (IGF1R in silver and Chr15 in red, 60X) Description INFORM IGF1R DNP Probe is a Dinitro-Phenol (DNP) labelled probe designed to quantitatively detect IGF1R genomic gain via chromogenic silver in situ hybridisation (SISH) using light microscopy in formalin-fixed, paraffin-embedded human tissue specimens following staining on VENTANA automated slide stainer instruments. Genomic gain of IGF1R is associated with non-small cell lung cancer (NSCLC). The IGF1R gene is located on chromosome 15 (15q26.3) and encodes the insulin-like growth factor-1 receptor protein. Visualisation of the IGF1R gene and Chromosome 15 centromere is either performed on separate slides using the Silver in situ hybridisation (SISH) DNP detection kit or on one single slide, with a dual colour staining technique using SISH DNP detection kit for the IGF1R gene and Red ISH DIG detection kit for Chromosome 15 centromere. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 188 NEXT> Molecular Probes | IHC & ISH HOME <PREV NEXT> INFORM MET Probe Assay Product INFORM MET DNA Probe INFORM Chromosome 7 Probe HybReady Rabbit Anti-DNP ultraView SISH Detection Kit ultraView Alkaline Phosphatase (AP) Red ISH Detection Kit ultraView Siler Wash II MET ISH Xenograft Control Slides Interpretation Guide Case 1: Amplified for MET on non-small cell lung carcinoma Part Number 800-4372 05575311001 800-4342 05278899001 780-4409 05917557001 780-4335 05273447001 780-001 05271967001 800-504 05278929001 780-003 05276101001 783-4342 05575303001 Please contact your sales representative Quantity 25 tests 25 tests 250 dispenses 100 tests 100 tests 100 tests 2L 10 slides Case 2: Amplified for MET on gastric carcinoma (NSCLC) Description INFORM MET DNA Probe is a Dinitro-Phenol (DNP) labelled probe designed to quantitatively detect MET (Mesenchymal-epithelial transition factor) genomic gain via chromogenic silver in situ hybridisation (SISH) using light microscopy in formalin-fixed, paraffinembedded human tissue specimens following staining on VENTANA automated slide stainer instruments. Genomic gain of MET is associated with non-small cell lung cancer (NSCLC) and gastric cancer. INFORM MET DNA Probe is designed to hybridise to the MET gene locus on chromosome 7 (q21-q31). Visualisation of the MET gene and Chromosome 7 centromere is either performed on separate slides using the Silver in situ hybridisation (SISH) detection kit or on one single slide, with a dual colour staining technique using SISH detection kit for the MET gene and Red ISH detection kit for Chromosome 7 centromere. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 189 IHC & ISH | Molecular Probes HOME <PREV INFORM TOP2A Probe Assay Product INFORM TOP2A DNA Probe INFORM Chromosome 17 Probe HybReady Rabbit Anti-DNP ultraView SISH Detection Kit ultraView Alkaline Phosphatase (AP) Red ISH Detection Kit ultraView Siler Wash II TOP2A ISH Xenograft Control Slides Interpretation Guide Case 1: Normal TOP2A Part Number 800-4348 05584957001 780-4331 05273412001 780-4409 05917557001 780-4335 05273447001 780-001 05271967001 800-504 05278929001 780-003 05276101001 783-4348 05584965001 Please contact your sales representative Quantity 25 tests 25 tests 250 dispenses 100 tests 100 tests 100 tests 2L 10 slides Case 2: Amplified for TOP2A Description INFORM TOP2A DNA Probe is a Dinitro-Phenol (DNP) labelled probe designed to detect TOP2A amplification or deletion via chromogenic silver in situ hybridisation (SISH) using light microscopy in formalin-fixed, paraffin-embedded human tissue specimens following staining on VENTANA automated slide stainer instruments. Amplification and deletion of TOP2A has been associated with invasive breast cancer. The TOP2A gene is located on chromosome 17 (17q21-22) and encodes the topoisomerase II alpha protein. Visualisation of the TOP2A gene and Chromosome 17 centromere is either performed on separate slides using the Silver in situ hybridisation (SISH) detection kit or on one single slide, with a dual colour staining technique using SISH detection kit for the TOP2A gene and Red ISH detection kit for Chromosome 17 centromere. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 190 NEXT> Molecular Probes | IHC & ISH HOME <PREV NEXT> HPV Probes: Tissue-Based Application INFORM HPV II Family 6 Probe (B) Part Number Quantity Status To be used with 800-2220 05278546001 50 Dispenses IVD ISH iVie w Blue Plus Detection Kit HPV 3 in 1 System Control Slides Description INFORM HPV II Family 6 (B) contains a cocktail of labelled human papillomavirus (HPV) genomic probes. The probe cocktail has demonstrated positive hybridisation to the following low risk genotypes: 6 and 11. INFORM HPV II Family 6 (B) Probe is to be used in conjunction with ISH iVIEW Blue Plus Detection Kit and other reagents to stain paraffin embedded tissue on the VENTANA BenchMark series automated slide stainers. INFORM HPV III Family 16 Probe (B) Part Number Quantity Status To be used with 800-4295 05278856001 50 Dispenses IVD ISH iVie w Blue Plus Detection Kit HPV 3 in 1 System Control Slides Description INFORM HPV III Family 16 (B) contains a cocktail of labelled human papillomavirus (HPV) genomic probes. The intended targets are the common genital HPV genotypes found to be associated with cervical cancer. The probe cocktail has demonstrated positive hybridisation to the following genotypes: 16, 18, 31, 33, 35, 45, 51, 52, 56, 58 and 66. INFORM HPV III Family 16 (B) Probe is to be used in conjunction with ISH iVIEW Blue Plus Detection Kit and other reagents to stain paraffin embedded tissue on the VENTANA BenchMark Series automated slide stainers. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 191 IHC & ISH | Molecular Probes HOME <PREV Other Molecular Probes INFORM EBER Probe Part Number Quantity Status To be used with 800-2842 05278660001 50 Dispenses IVD ISH iView Blue Detection Kit Description INFORM EBER Probe is a fluorescein-labelled oligonucleotide probe intended to identify, by in situ hybridisation (ISH) and light microscopy, cells expressing Epstein-Barr encoded RNA (EBER) in sections of formalin-fixed, paraffin-embedded tissue. INFORM EBER Probe specifically hybridises to EBER RNA transcripts. Positive results aid in the identification of cells infected with Epstein-Barr virus. INFORM Kappa Probe Part Number Quantity Status To be used with 800-2843 05278678001 50 Dispenses IVD ISH iView Blue Detection Kit Description INFORM Kappa Probe is a fluorescein-labelled oligonucleotide probe intended to detect cytoplasmic mRNA for kappa immunoglobulin light chain in formalin-fixed, paraffin-embedded tissue samples. INFORM Kappa Probe is typically used in conjunction with the INFORM Lambda Probe for lambda immunoglobulin light chain. The combined assays assist distinction between polyclonal (kappa positive, lambda positive mRNA) proliferations associated with benign reactive plasma cell and B-cell lymphoid proliferations; and monoclonal (either kappa positive and lambda negative or kappa negative and lambda positive) proliferations associated with neoplastic plasma cell and B-cell lymphoid proliferations. References 1. Pringle JH, et al., J. Pathol. 162(3): 197-207,1990. 2. Beck RC, et al. Diagn. Mol. Pathol. 12:14-20, 2003. 3. Euscher E, J. Gynecol Pathol. 21: 383-390, 2002.2003-03-31. 4. College of American Pathologists Laboratory Accreditation Program, Anatomic Pathology Checklist, 2001. INFORM Lambda Probe Part Number Quantity Status To be used with 800-2844 05278686001 50 Dispenses IVD ISH iView Blue Detection Kit Description INFORM Lambda Probe is a fluorescein-labelled oligonucleotide probe intended to detect cytoplasmic mRNA for lambda immunoglobulin light chain in formalin-fixed, paraffin-embedded tissue samples. INFORM Lambda Probe is typically used in conjunction with the INFORM Kappa Probe for kappa immunoglobulin light chain. The combined assays assist distinction between polyclonal (kappa positive, lambda positive mRNA) proliferations associated with benign reactive plasma cell and B-cell lymphoid proliferations; and monoclonal (either kappa positive and lambda negative or kappa negative and lambda positive) proliferations associated with neoplastic plasma cell and B-cell lymphoid proliferations. References 1. Pringle JH, et al., J. Pathol. 162(3): 197-207,1990. 2. Beck RC, et al. Diagn. Mol. Pathol. 12:14-20, 2003. 3. Euscher E, J. Gynecol Pathol. 21: 383-390, 2002.2003-03-31. 4. College of American Pathologists Laboratory Accreditation Program, Anatomic Pathology Checklist, 2001. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 192 NEXT> Ancillary Reagents | IHC & ISH HOME <PREV NEXT> Ancillary Reagents Amplification Amplification Kit Part Number Quantity IHC ISH 760-080 05266114001 100 tests Description May be used in conjunction with VENTANA IHC detection kits to increase the signal intensity of weak staining mouse and rabbit primary antibodies. Reagents are provided pre-diluted and ready-to-use for convenient operation on VENTANA BenchMark series automated slide stainers. Components: Amplifier A, Amplifier B. OptiView Amplification Kit Part Number Quantity 760-099 06396518001 50 tests IHC ISH Description OptiView Amplification Kit can only be used with OptiView IHC DAB Kit and provides a significant increase in sensitivity without sacrificing specificity. The OptiView Amplification kit builds on the proprietary, non-endogenous hapten system used in the OptiView base kit. The exclusive OptiView software provides increased control over the OptiView Amplification kit components allowing optimisation in intensity while minimising primary antibody incubation times. Components: OptiView Amplifier, OptiView Amplification H2O2, OptiView Amplification Multimer. Blockers Endogenous Biotin Blocking Kit Part Number Quantity 760-050 05266092001 250 tests IHC ISH Description Endogenous Biotin Blocking Kit may be used to aid in the reduction of non-specific staining caused by endogenous biotin present in cells and tissues. Blocker A specifically binds to endogenous biotin present in the tissue; Blocker B saturates the remaining binding sites of Blocker A, thus reducing the non-specific staining. For use on VENTANA BenchMark series automated slide stainers. Components: Blocker A, Blocker B. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 193 IHC & ISH | Ancillary Reagents HOME ISH Block Part Number Quantity 780-4461 05994918001 100 tests IHC <PREV ISH Description ISH Block is used to decrease non-specific hybridisation of nick-labelled probes during in situ hybridisation staining process. ISH Block reagent may be used in conjunction with Ventana ISH probes and other accessory reagents to stain single colour slides on the VENTANA BenchMark series automated slide stainers. Single, ready-to-use dispenser. NeuVision Blocking Reagent Part Number Quantity 760-1028 05266220001 250 tests IHC ISH Description Ready-to-use protein blocking solution suitable for use with the NeuVision Nuclear Stain Kit. It is intended to be used in the preparation of samples for interpretation by image analysis. This reagent may be used to aid in the reduction of non-specific staining. For use on VENTANA BenchMark series automated slide stainers. Single, ready-to-use dispenser. Bulk Solutions Cell Conditioning 1 (CC1) Part Number Quantity Format 950-124 05279801001 2L bottle Ready to use IHC ISH Description Pre-diluted solution optimised for use on the VENTANA BenchMark GX and VENTANA BenchMark XT automated slide stainers as a pretreatment step in the processing of tissue samples for immunohistochemistry and in situ hybridisation reactions. CC1 is a tris-based buffer with a slightly basic pH, which, at elevated temperatures is capable of disrupting the covalent bonds formed by formalin in tissue. Removing these bonds allows renaturation of protein molecules and increases antibody accessibility. Often these changes result in significant gains in antibody binding and improved signal to noise ratios. ULTRA Cell Conditioning 1 (ULTRA CC1) Part Number Quantity Format 950-224 05424569001 2L bottle Ready to use IHC ISH Description Pre-diluted solution optimised for use on the VENTANA BenchMark ULTRA automated slide stainer as a pretreatment step in the processing of tissue samples for immunohistochemistry and in situ hybridisation reactions. ULTRA CC1 is a tris-based buffer with a slightly basic pH, which, at elevated temperatures, is capable of hydrolising the covalent bonds formed by formalin in tissue. Removing these bonds allows renaturation of protein molecules and increases antibody accessibility. Often these changes result in significant gains in antibody binding and improved signal to noise ratios. Cell Conditioning 2 (CC2) Part Number Quantity Format 950-123 05279798001 1L bottle Ready to use IHC ISH Description Pre-diluted solution optimised for use on the VENTANA BenchMark GX and VENTANA BenchMark XT automated slide stainers as a pretreatment step in the processing of tissue samples for immunohistochemistry and in situ hybridisation reactions. CC2 is a citrate buffer at a slightly acidic pH, which, at elevated temperatures, is capable of disrupting the covalent bonds formed by formalin in tissue. Removing these bonds allows renaturation of protein molecules and increases antibody accessibility. Often these changes result in significant gains in antibody binding and improved signal to noise ratios. The products that appear on this page are IVD (for in vitro diagnostic use). Ventana part number in black, Roche item number in blue. 194 NEXT> Ancillary Reagents | IHC & ISH HOME ULTRA Cell Conditioning 2 (ULTRA CC2) Part Number Quantity Format 950-223 05424542001 1L bottle Ready to use <PREV NEXT> IHC ISH Description Pre-diluted solution optimised for use on the VENTANA BenchMark ULTRA automated slide stainer as a pretreatment step in the processing of tissue samples for immunohistochemistry and in situ hybridisation reactions. ULTRA CC2 is a citrate buffer at a slightly acidic pH, which, at elevated temperatures, is capable of hydrolysing the covalent bonds formed by formalin and formaldehyde in tissue. Removing these bonds allows renaturation of protein molecules and increases antibody accessibility. Often these changes result in significant gains in antibody binding and improved signal to noise ratios. EZ Prep (10X) Part Number Quantity Format 950-102 05279771001 2L bottle Concentrate IHC ISH Description Solution used for paraffin removal from tissue samples and to dilute 2X SSC during stringency washes during in situ hybridisation (ISH) reactions carried out on the VENTANA BenchMark series automated slide stainers. Liquid Coverslip (High Temperature) Part Number Quantity Format 650-010 05264839001 2L bottle Ready to use IHC ISH Description Solution used as a barrier between the aqueous reagents and the air, which has been optimised for use on the VENTANA BenchMark and VENTANA BenchMark XT automated slide stainers. This barrier prevents evapouration, thereby providing a stable aqueous environment for the immunohistochemistry or in situ hybridisation reactions. ULTRA LCS Part Number Quantity Format 650-210 05424534001 2L bottle Ready to use IHC ISH Description Solution used as a barrier between the aqueous reagents and the air, which has been optimised for use on the VENTANA BenchMark ULTRA automated slide stainer. This barrier prevents evapouration, thereby providing a stable aqueous environment for immunohistochemistry or in situ hybridisation reactions. Reaction Buffer (10X) Part Number Quantity Format 950-300 05353955001 2L bottle Concentrate IHC ISH Description Buffered solution used to rinse slides between staining steps and to provide a stable aqueous environment for the immunohistochemistry and in situ hybridisation (ISH) reactions carried out on VENTANA BenchMark series automated slide stainers. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 195 IHC & ISH | Ancillary Reagents HOME SSC (10X) Part Number Quantity Format <PREV IHC ISH 950-110 05353947001 2L bottle Concentrate Description Sodium citrate, sodium chloride buffer used for stringency washes and to rinse slides between staining steps, It provides a stable aqueous environment for the in situ hybridisation reactions carried out on a VENTANA BenchMark series automated slide stainer. SSC (10X) needs to be used at a final 2X working concentration for hybridisation reactions. The VENTANA automated slide stainer automatically further dilutes the 2X SSC solution as needed for stringency washes. ultraView Silver Wash II Part Number Quantity Format IHC ISH 780-003 05446724001 2L bottle Ready to use Description ultraView Silver Wash II solution is used to rinse slides between staining steps and provide a stable aqueous environment for the in situ hybridisation chromogen reaction carried out on VENTANA BenchMark series automated slide stainers when using ultraView SISH Detection Kit. Counterstains Bluing Reagent Part Number Quantity IHC ISH 760-2037 05266769001 250 tests Description Ready-to-use solution that can be applied after hematoxylin to change the hue of hematoxylin to a blue colour. For use on VENTANA BenchMark series automated slide stainers. Single, ready-to-use dispenser. Hematoxylin Part Number Quantity 760-2021 05266726001 250 tests IHC ISH Description A modified Gill’s hematoxylin intended for staining cellular nuclei on slides containing cells from frozen tissue, formalin fixed and paraffin embedded tissue or cytologic preparations. For use on VENTANA BenchMark series automated slide stainers. Single, ready-to-use dispenser. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 196 NEXT> Ancillary Reagents | IHC & ISH HOME Hematoxylin II Part Number Quantity 790-2208 05277965001 250 tests <PREV NEXT> IHC ISH Description A modified Mayer’s hematoxylin intended for staining cellular nuclei on slides containing cells from frozen tissue, formalin-fixed and paraffinembedded tissue or cytologic preparations. For use on VENTANA BenchMark series automated slide stainers. Single, ready-to-use dispenser. NeuVision Nuclear Stain Kit Part Number Quantity 760-085 05266149001 250 tests IHC ISH Description For use with imaging applications. Reagents are provided prediluted and ready-to-use for convenient operation. For use on VENTANA BenchMark series automated slide stainers. Components: NeuVision Nuclear Stain, NeuVision Bluing Reagent, NeuVision Nuclear Diluent. Red Counterstain II Part Number Quantity 780-2218 05272017001 100 tests IHC ISH Description Red Counterstain II provides pink background staining in nuclei and cytoplasm of formalin-fixed, paraffin-embedded tissue sections, which is intended to aid microscopic bright field observation for chromogenic in situ hybridisation (ISH) reactions. For use on VENTANA BenchMark series automated slide stainers. Single, ready-to-use dispenser. Diluents Antibody Diluent Part Number Quantity 251-018 05261899001 100 ml bottle IHC ISH Description Buffered, proteinaceous solution used to dilute rabbit and mouse antibodies. HybReady Solution Part Number Quantity 780-4409 05917557001 250 dispenses IHC ISH Description HybReady Solution is a formamide-based buffer used to dilute probes and to create appropriate hybridisation conditions on the slides for in situ hybridisation assays on VENTANA BenchMark series automated slide stainers. Single, ready-to-use dispenser. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 197 IHC & ISH | Ancillary Reagents Enzymes HOME Protease 1 Part Number Quantity 760-2018 05266688001 250 tests <PREV IHC ISH Description Ready-to-use endopeptidase (alkaline protease) of the serine protease family that cleaves protein in the tissue section, allowing primary antibodies to recognise and bind target epitope(s). The reagent is intended for enzymatic digestion of tissue sections. With 0.5 units/ml alkaline protease enzyme activity, Protease 1 is the strongest enzymatic pretreatment available for IHC. Single, ready-to-use dispenser. Protease 2 Part Number Quantity 760-2019 05266696001 250 tests IHC ISH Description Ready-to-use endopeptidase (alkaline protease) of the serine protease family that cleaves protein in the tissue section, allowing primary antibodies to recognise and bind target epitope(s). The reagent is intended for enzymatic digestion of tissue sections. With 0.1 units/ml alkaline protease enzyme activity, Protease 2 is the intermediate-strength enzymatic pretreatment available for IHC. Single, ready-to-use dispenser. Protease 3 Part Number Quantity 760-2020 05266718001 250 tests IHC ISH Description Ready-to-use endopeptidase (alkaline protease) of the serine protease family that cleaves protein in the tissue section, allowing primary antibodies to recognise and bind target epitope(s). The reagent is intended for enzymatic digestion of tissue sections. With 0.02 units/ml alkaline protease enzyme activity, Protease 3 is the mildest enzymatic pretreatment available for IHC. Single, ready-to-use dispenser. ISH Protease 1 Part Number Quantity 780-4147 05273315001 200 tests IHC ISH Description Endopeptidase (alkaline protease) of the serine protease family which is used in the in situ hybridisation process to permeabilise cell membranes and remove protein that surrounds the target DNA or RNA sequences of interest. The reagent is intended for enzymatic digestion of sections of formalin-fixed, paraffin-embedded tissue or whole cell preparations. With 0.5 units/ml alkaline protease enzyme activity, ISH Protease 1 is the strongest enzymatic pretreatment available for ISH. Single, ready-to-use dispenser. ISH Protease 2 Part Number Quantity 780-4148 05273323001 200 tests IHC ISH Description Endopeptidase (alkaline protease) of the serine protease family which is used in the in situ hybridisation process to permeabilise cell membranes and remove protein that surrounds the target DNA or RNA sequences of interest. The reagent is intended for enzymatic digestion of sections of formalin-fixed, paraffin-embedded tissue or whole cell preparations. With 0.1 units/ml alkaline protease enzyme activity, ISH Protease 2 is the intermediate-strength enzymatic pretreatment available for ISH. Single, ready-to-use dispenser. ISH Protease 3 Part Number Quantity 780-4149 05273331001 200 tests IHC ISH Description Endopeptidase (alkaline protease) of the serine protease family which is used in the in situ hybridisation process to permeabilise cell membranes and remove protein that surrounds the target DNA or RNA sequences of interest. The reagent is intended for enzymatic digestion of sections of formalin-fixed, paraffin embedded tissue or whole cell preparations. With 0.02 units/ml alkaline protease enzyme activity, ISH Protease 3 is the mildest enzymatic pretreatment available for ISH. Single, ready-to-use dispenser. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 198 NEXT> Ancillary Reagents | IHC & ISH HOME <PREV NEXT> Negative Control Reagents ISH Negative Control Part Number Quantity 780-2902 05272165001 50 tests IHC ISH Description ISH Negative Control is to be used to assess the background noise within the specimen sample under investigation. Single, ready-to-use dispenser. Negative Control Probe Part Number Quantity 800-2847 05278716001 50 tests IHC ISH Description Negative Control Probe consists of the tail sequence used in our oligonucleotide probes and may be used as a negative control to assess the background noise within the specimen under investigation. Single, ready-to-use dispenser. Positive Control Reagents Alu Positive Control Probe Part Number Quantity 800-2845 05278694001 50 tests IHC ISH Description Fluorescein-labelled oligonucleotide probe that has an affinity to human Alu specific sequences. Single, ready-to-use dispenser. Alu Positive Control Probe II Part Number Quantity 780-2221 05272041001 50 tests IHC ISH Description DNP-labelled probes to determine the preservation of DNA during specimen collection, processing, fixation and handling. Single, ready-touse dispenser. RNA Positive Control Probe Part Number Quantity 800-2846 05278708001 50 tests IHC ISH Description Fluorescein-labelled oligonucleotide probe that has an affinity to the poly-A tail in mRNA. Single, ready-to-use dispenser. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 199 IHC & ISH | Ancillary Reagents HOME <PREV Specimen/Control Slides IHC ISH PATHWAY HER-2 4 in 1 Control Slides Part Number Quantity 781-2991 05273510001 10 slides Description PATHWAY HER-2 4 in 1 Control Slides consist of formalin fixed, paraffin embedded, cultured human breast cell lines and are intended to be used as assayed, semi-quantitative quality control material, in conjunction with PATHWAY HER-2 (4B5) Primary Antibody, for use in monitoring the performance of the immunohistochemical c-erbB-2/HER-2 staining process on the VENTANA BenchMark series automated slide stainers. The clinical interpretation of any staining or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests. (300x) The Level 0 Cell Line Control (MCF-7) is completely negative. (300x) The Level 1+ Cell Line Control (T-47D) stains at an intensity level of 1+. (300x) The Level 2+ Control Cell Line (MDA-MB-453) stains at an intensity level of 2+ with complete “ring” pattern in >10% of the cells. (300x) The Level 3+ Cell Line Control (BT-474) is a high expression cell line that stains at an intensity level of 3+ in approximately 100% of the cells. EBER Positive Specimen Slides Part Number Quantity 801-2842 05278953001 10 slides IHC ISH Description EBER (Epstein-Barr Virus Encoded RNA) Positive Specimen Slides contain 10 slides for use as an unassayed control for the qualitative determination of the in situ hybridisation (ISH) staining function on the VENTANA BenchMark series automated slide stainer. Each slide contains two cell pellets, one negative and one positive for early RNA transcript of EBV infection, fixed in 10% neutral buffered formalin (NBF). Light microscopy is used to detect the staining reaction. EGFR ISH Xenograft Control Slides Part Number Quantity 783-4343 05276110001 10 slides IHC ISH Description EGFR ISH Xenograft Control Slides are intended to be used as assayed, semi-quantitative quality control material in conjunction with the INFORM® EGFR DNA Probe and INFORM® Chromosome 7 Probe for use in monitoring performance of the probes for in situ hybridisation (ISH). Light microscopy is used to detect the staining reaction. Two human carcinoma cell lines with different EGFR gene status are generated as tumours (xenografts) in SCID mice. The two xenografts are paraffin embedded, sectioned and placed on charged slides. HER2 DUAL ISH 3-in-1 Xenograft Slides Part Number Quantity 783-4422 05640300001 10 slides IHC ISH Description HER2 Dual ISH 3-in-1 Xenograft Slides are intended to be used for initial assay installation and/or troubleshooting activities in conjunction with the INFORM HER2 Dual ISH DNA Probe Cocktail on the VENTANA BenchMark series automated slide stainer. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 200 NEXT> Ancillary Reagents | IHC & ISH HOME HER2 3-in-1 Xenograft Control Slides Part Number Quantity 783-4332 05276101001 10 slides IHC <PREV NEXT> ISH Description HER2 3-in-1 Xenograft Control Slides are intended to be used as assayed, semi-quantitative quality control material in conjunction with the INFORM HER2 DNA Probe and INFORM Chromosome 17 Probe for use in monitoring performance of the probes for in situ hybridisation (ISH). Light microscopy is used to detect the staining reaction. Three different human carcinoma cell lines, each with a different HER2 gene status that represents the dynamic range, are generated as tumours (xenografts) in SCID mice. The three xenografts are paraffin embedded, sectioned and placed on charged slides. HPV 3 in 1 System Control Slides Part Number Quantity 783-2219 05273587001 10 slides IHC ISH Description HPV 3 in 1 System Control Slides are used to monitor the performance of automated HPV in situ hybridisation staining assays. Established controls, such as HPV 3 in 1 System Control Slides, should be processed and run with all clinical specimens. The CaSki section is a cell line that reportedly contains approximately 200 - 400 copies of human papillomavirus (HPV) type 16 per cell and the HeLa section is a cell line that reportedly contains approximately 10 - 50 copies of HPV type 18 per cell. The C-33A negative section is a cell line which is an HPV negative human cervical carcinoma. HPV Family 6 System Control Slides (B) Part Number Quantity 782-2839 05273528001 10 slides IHC ISH Description Each HPV Family 6 System Control Slides (B) contains one formalin-fixed, paraffin-embedded condyloma tissue section. HPV Family 6 System Control Slides (B) are designed to allow the user to check ISH staining function on VENTANA BenchMark series automated slide stainers. IGF1R ISH Xenograft Slides Part Number Quantity 783-4458 05994977001 10 slides IHC ISH Description IGF1R ISH Xenograft Slides are intended to be used for initial assay installation and/or troubleshooting activities in conjunction with the INFORM IGF1R DNP Probe and INFORM Chromosome 15 DIG Probe on VENTANA BenchMark series automated slide stainers. Kappa Positive Specimen Slides Part Number Quantity 801-2843 05278961001 10 slides IHC ISH Description Kappa Positive Specimen Slides contain 10 slides for use as an unassayed control for the qualitative determination of the in situ hybridisation (ISH) staining function on the VENTANA BenchMark series automated slide stainer. Each slide contains one paraffinembedded, 10% neutral buffered formalin (NBF) fixed tissue section of normal human tonsil. Slides are designed to allow the user to confirm detection of kappa immunoglobulin light chain messenger RNA (mRNA) in plasma cells. Light microscopy is used to detect the staining reaction. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 201 IHC & ISH | Ancillary Reagents HOME Lambda Positive Specimen Slides Part Number Quantity 801-2844 05278970001 10 slides IHC <PREV ISH Description Lambda Positive Specimen Slides contain 10 slides for use as an unassayed control for the qualitative determination of the in situ hybridisation (ISH) staining function on the VENTANA BenchMark series automated slide stainer. Each slide contains one paraffinembedded, 10% neutral buffered formalin (NBF) fixed tissue section of normal human tonsil. Slides are designed to allow the user to confirm detection of lambda immunoglobulin light chain messenger RNA (mRNA) in plasma cells. Light microscopy is used to detect the staining reaction. MET ISH Xenograft Control Slides Part Number Quantity 783-4472 05575303001 10 slides IHC ISH Description MET ISH Xenograft Slides are intended to be used for initial assay installation and/or troubleshooting activities in conjunction with the INFORM MET DNA Probe and INFORM Chromosome 7 Probe on VENTANA BenchMark series automated slide stainers. TOP2A ISH Xenograft Control Slides Part Number Quantity 783-4348 05584965001 10 slides IHC ISH Description The TOP2A ISH Xenograft Control Slides are designed to act as a system-level control to demonstrate that the system of reagents is functioning as intended. Light microscopy is used to detect the staining reaction. Three human carcinoma cell lines with different TOP2A gene status are generated as tumours (xenografts) in SCID mice. The three xenografts are paraffin embedded, sectioned and placed on charged slides. Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 202 NEXT> Ancillary Reagents | IHC & ISH HOME User-fillable dispensers/Prep Kits 50 Test Prep Kits Product 50 Test Prep Kit # 501 50 Test Prep Kit # 502 50 Test Prep Kit # 503 50 Test Prep Kit # 504 50 Test Prep Kit # 505 50 Test Prep Kit # 506 50 Test Prep Kit # 507 50 Test Prep Kit # 508 50 Test Prep Kit # 509 50 Test Prep Kit # 510 50 Test Prep Kit # 511 50 Test Prep Kit # 512 50 Test Prep Kit # 513 50 Test Prep Kit # 514 50 Test Prep Kit # 515 50 Test Prep Kit # 516 50 Test Prep Kit # 517 50 Test Prep Kit # 518 50 Test Prep Kit # 519 50 Test Prep Kit # 520 50 Test Prep Kit # 521 50 Test Prep Kit # 522 50 Test Prep Kit # 523 50 Test Prep Kit # 524 50 Test Prep Kit # 525 Part Number 783-3457 05275814001 783-3458 05275822001 783-3459 05275849001 783-3460 05275857001 783-3461 05275865001 783-3462 05275873001 783-3463 05275881001 783-3464 05275890001 783-3465 05275903001 783-3466 05275911001 783-3467 05275920001 783-3468 05275938001 783-3469 05275946001 783-3470 05275954001 783-3471 05275962001 783-3472 05275989001 783-3473 05275997001 783-3474 05276004001 783-3475 05276012001 783-3476 05276039001 783-3477 05276047001 783-3478 05276055001 783-3479 05276063001 783-3480 05276071001 783-3481 05276080001 100 Test Prep Kits Product 100 Test Prep Kit # 1 100 Test Prep Kit # 2 100 Test Prep Kit # 3 100 Test Prep Kit # 4 100 Test Prep Kit # 5 100 Test Prep Kit # 6 100 Test Prep Kit # 7 100 Test Prep Kit # 8 100 Test Prep Kit # 9 Part Number 783-2851 05273617001 783-2852 05273625001 783-2853 05273633001 783-2854 05273641001 783-2855 05273650001 783-2856 05273668001 783-2857 05273676001 783-2858 05273684001 783-2859 05273692001 Product 100 Test Prep Kit # 10 100 Test Prep Kit # 11 100 Test Prep Kit # 12 100 Test Prep Kit # 13 100 Test Prep Kit # 14 100 Test Prep Kit # 15 100 Test Prep Kit # 16 100 Test Prep Kit # 17 100 Test Prep Kit # 18 100 Test Prep Kit # 19 100 Test Prep Kit # 20 100 Test Prep Kit # 21 100 Test Prep Kit # 22 100 Test Prep Kit # 23 100 Test Prep Kit # 24 100 Test Prep Kit # 25 100 Test Prep Kit # 26 100 Test Prep Kit # 27 100 Test Prep Kit # 28 100 Test Prep Kit # 29 100 Test Prep Kit # 30 100 Test Prep Kit # 31 100 Test Prep Kit # 32 100 Test Prep Kit # 33 100 Test Prep Kit # 34 100 Test Prep Kit # 35 100 Test Prep Kit # 36 100 Test Prep Kit # 37 100 Test Prep Kit # 38 100 Test Prep Kit # 39 100 Test Prep Kit # 40 100 Test Prep Kit # 41 100 Test Prep Kit # 42 100 Test Prep Kit # 43 100 Test Prep Kit # 44 100 Test Prep Kit # 45 100 Test Prep Kit # 46 100 Test Prep Kit # 47 100 Test Prep Kit # 48 100 Test Prep Kit # 49 100 Test Prep Kit # 50 100 Test Prep Kit # 51 100 Test Prep Kit # 52 <PREV NEXT> Part Number 783-2860 05273706001 783-2861 05273714001 783-2862 05273722001 783-2863 05273749001 783-2864 05273757001 783-2865 05273765001 783-2866 05273773001 783-2867 05273781001 783-2868 05273790001 783-2869 05273803001 783-2870 05273811001 783-2871 05273820001 783-2872 05273838001 783-2873 05273846001 783-2874 05273854001 783-2875 05273862001 783-2876 05273889001 783-2877 05273897001 783-2878 05273919001 783-2879 05273927001 783-2880 05273935001 783-2881 05273943001 783-2882 05273951001 783-2883 05273960001 783-2884 05273978001 783-2885 05273986001 783-2886 05273994001 783-2887 05274001001 783-2888 05274010001 783-2889 05274028001 783-2890 05274036001 783-2891 05274044001 783-2892 05274052001 783-2893 05274079001 783-2894 05274087001 783-2895 05274095001 783-2896 05274109001 783-2897 05274117001 783-2898 05274125001 783-2899 05274133001 783-2900 05274141001 783-3007 05274168001 783-3008 05274176001 Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 203 IHC & ISH | Ancillary Reagents HOME Product 100 Test Prep Kit # 53 100 Test Prep Kit # 54 100 Test Prep Kit # 55 100 Test Prep Kit # 56 100 Test Prep Kit # 57 100 Test Prep Kit # 58 100 Test Prep Kit # 59 100 Test Prep Kit # 60 100 Test Prep Kit # 61 100 Test Prep Kit # 62 100 Test Prep Kit # 63 100 Test Prep Kit # 64 100 Test Prep Kit # 65 100 Test Prep Kit # 66 100 Test Prep Kit # 67 100 Test Prep Kit # 68 100 Test Prep Kit # 69 100 Test Prep Kit # 70 100 Test Prep Kit # 71 100 Test Prep Kit # 72 100 Test Prep Kit # 73 100 Test Prep Kit # 74 100 Test Prep Kit # 75 100 Test Prep Kit # 76 100 Test Prep Kit # 77 100 Test Prep Kit # 78 100 Test Prep Kit # 79 100 Test Prep Kit # 80 100 Test Prep Kit # 81 100 Test Prep Kit # 82 100 Test Prep Kit # 83 100 Test Prep Kit # 84 100 Test Prep Kit # 85 100 Test Prep Kit # 86 100 Test Prep Kit # 87 100 Test Prep Kit # 88 100 Test Prep Kit # 89 100 Test Prep Kit # 90 100 Test Prep Kit # 91 100 Test Prep Kit # 92 100 Test Prep Kit # 93 100 Test Prep Kit # 94 Part Number 783-3009 05274184001 783-3010 05274192001 783-3011 05274206001 783-3012 05274214001 783-3013 05274222001 783-3014 05274249001 783-3015 05274257001 783-3016 05274265001 783-3017 05274273001 783-3018 05274281001 783-3019 05274290001 783-3020 05274303001 783-3021 05274311001 783-3022 05274320001 783-3023 05274338001 783-3024 05274346001 783-3025 05274354001 783-3026 05274362001 783-3027 05274389001 783-3028 05274397001 783-3029 05274419001 783-3030 05274427001 783-3031 05274435001 783-3032 05274443001 783-3033 05274451001 783-3034 05274460001 783-3035 05274478001 783-3036 05274486001 783-3037 05274494001 783-3038 05274508001 783-3039 05274516001 783-3040 05274524001 783-3041 05274532001 783-3042 05274559001 783-3043 05274567001 783-3044 05274575001 783-3045 05274583001 783-3046 05274591001 783-3047 05274605001 783-3048 05274613001 783-3049 05274621001 783-3050 05274630001 Product 100 Test Prep Kit # 95 100 Test Prep Kit # 96 100 Test Prep Kit # 97 100 Test Prep Kit # 98 100 Test Prep Kit # 99 100 Test Prep Kit # 100 100 Test Prep Kit # 101 100 Test Prep Kit # 102 100 Test Prep Kit # 103 100 Test Prep Kit # 104 100 Test Prep Kit # 105 100 Test Prep Kit # 106 100 Test Prep Kit # 107 100 Test Prep Kit # 108 100 Test Prep Kit # 109 100 Test Prep Kit # 110 100 Test Prep Kit # 111 100 Test Prep Kit # 112 100 Test Prep Kit # 113 100 Test Prep Kit # 114 100 Test Prep Kit # 115 100 Test Prep Kit # 116 100 Test Prep Kit # 117 100 Test Prep Kit # 118 100 Test Prep Kit # 119 100 Test Prep Kit # 120 100 Test Prep Kit # 121 100 Test Prep Kit # 122 100 Test Prep Kit # 123 100 Test Prep Kit # 124 100 Test Prep Kit # 125 100 Test Prep Kit # 126 100 Test Prep Kit # 127 100 Test Prep Kit # 128 100 Test Prep Kit # 129 100 Test Prep Kit # 130 100 Test Prep Kit # 131 100 Test Prep Kit # 132 100 Test Prep Kit # 133 100 Test Prep Kit # 134 100 Test Prep Kit # 135 100 Test Prep Kit # 136 Part Number 783-3051 05274648001 783-3052 05274656001 783-3053 05274664001 783-3054 05274672001 783-3055 05274699001 783-3056 05274702001 783-3057 05274729001 783-3058 05274737001 783-3059 05274745001 783-3060 05274753001 783-3061 05274761001 783-3062 05274770001 783-3063 05274788001 783-3064 05274796001 783-3065 05274800001 783-3066 05274818001 783-3067 05274826001 783-3068 05274834001 783-3069 05274842001 783-3070 05274869001 783-3071 05274877001 783-3072 05274885001 783-3073 05274893001 783-3074 05274907001 783-3075 05274915001 783-3076 05274923001 783-3077 05274931001 783-3078 05274940001 783-3079 05274958001 783-3080 05274966001 783-3081 05274974001 783-3082 05274982001 783-3083 05275008001 783-3084 05275016001 783-3085 05275024001 783-3086 05275032001 783-3087 05275059001 783-3088 05275067001 783-3089 05275075001 783-3090 05275083001 783-3091 05275091001 783-3092 05275105001 Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 204 <PREV NEXT> Ancillary Reagents | IHC & ISH HOME Product 100 Test Prep Kit # 137 100 Test Prep Kit # 138 100 Test Prep Kit # 139 100 Test Prep Kit # 140 100 Test Prep Kit # 141 100 Test Prep Kit # 142 100 Test Prep Kit # 143 100 Test Prep Kit # 144 100 Test Prep Kit # 145 100 Test Prep Kit # 146 100 Test Prep Kit # 147 100 Test Prep Kit # 148 100 Test Prep Kit # 149 100 Test Prep Kit # 150 100 Test Prep Kit # 151 100 Test Prep Kit # 152 100 Test Prep Kit # 153 100 Test Prep Kit # 154 100 Test Prep Kit # 155 100 Test Prep Kit # 156 100 Test Prep Kit # 157 100 Test Prep Kit # 158 100 Test Prep Kit # 159 100 Test Prep Kit # 160 100 Test Prep Kit # 161 100 Test Prep Kit # 162 100 Test Prep Kit # 163 100 Test Prep Kit # 164 100 Test Prep Kit # 165 100 Test Prep Kit # 166 100 Test Prep Kit # 167 100 Test Prep Kit # 168 100 Test Prep Kit # 169 100 Test Prep Kit # 170 100 Test Prep Kit # 171 100 Test Prep Kit # 172 100 Test Prep Kit # 173 100 Test Prep Kit # 174 100 Test Prep Kit # 175 100 Test Prep Kit # 176 100 Test Prep Kit # 177 100 Test Prep Kit # 178 Part Number 783-3093 05275113001 783-3094 05275121001 783-3095 05275130001 783-3096 05275148001 783-3097 05275156001 783-3098 05275164001 783-3099 05275172001 783-3100 05275199001 783-3101 05275202001 783-3102 05275229001 783-3103 05275237001 783-3104 05275245001 783-3105 05275253001 783-3106 05275261001 783-3107 05275270001 783-3108 05275288001 783-3109 05275296001 783-3110 05275300001 783-3111 05275318001 783-3112 05275326001 783-3113 05275334001 783-3114 05275342001 783-3115 05275369001 783-3116 05275377001 783-3117 05275385001 783-3118 05275393001 783-3119 05275407001 783-3120 05275415001 783-3121 05275423001 783-3122 05275431001 783-3123 05275440001 783-3124 05275458001 783-3125 05275466001 783-3126 05275474001 783-3127 05275482001 783-3128 05275504001 783-3129 05275512001 783-3130 05275539001 783-3131 05275547001 783-3132 05275555001 783-3133 05275563001 783-3134 05275571001 Product 100 Test Prep Kit # 179 100 Test Prep Kit # 180 100 Test Prep Kit # 181 100 Test Prep Kit # 182 100 Test Prep Kit # 183 100 Test Prep Kit # 184 100 Test Prep Kit # 185 100 Test Prep Kit # 186 100 Test Prep Kit # 187 100 Test Prep Kit # 188 100 Test Prep Kit # 189 100 Test Prep Kit # 190 100 Test Prep Kit # 191 100 Test Prep Kit # 192 100 Test Prep Kit # 193 100 Test Prep Kit # 194 100 Test Prep Kit # 195 100 Test Prep Kit # 196 100 Test Prep Kit # 197 100 Test Prep Kit # 198 100 Test Prep Kit # 199 100 Test Prep Kit # 200 <PREV NEXT> Part Number 783-3135 05275580001 783-3136 05275598001 783-3137 05275601001 783-3138 05275610001 783-3139 05275628001 783-3140 05275636001 783-3141 05275644001 783-3142 05275652001 783-3143 05275679001 783-3144 05275687001 783-3145 05275695001 783-3146 05275709001 783-3147 05275717001 783-3148 05275725001 783-3149 05275733001 783-3150 05275741001 783-3151 05275750001 783-3152 05275768001 783-3153 05275776001 783-3154 05275784001 783-3155 05275792001 783-3156 05275806001 250 Test Prep Kits Product 250 Test Prep Kit # 1 250 Test Prep Kit # 2 250 Test Prep Kit # 3 250 Test Prep Kit # 4 250 Test Prep Kit # 5 250 Test Prep Kit # 6 250 Test Prep Kit # 7 250 Test Prep Kit # 8 250 Test Prep Kit # 9 250 Test Prep Kit # 10 250 Test Prep Kit # 11 250 Test Prep Kit # 12 250 Test Prep Kit # 13 250 Test Prep Kit # 14 250 Test Prep Kit # 15 250 Test Prep Kit # 16 250 Test Prep Kit # 17 Part Number 786-2851 05276284001 786-2852 05276292001 786-2853 05276306001 786-2854 05276314001 786-2855 05276322001 786-2856 05276349001 786-2857 05276357001 786-2858 05276365001 786-2859 05276373001 786-2860 05276381001 786-2861 05276390001 786-2862 05276403001 786-2863 05276411001 786-2864 05276420001 786-2865 05276438001 786-2866 05276446001 786-2867 05276454001 Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 205 IHC & ISH | Ancillary Reagents HOME Product 250 Test Prep Kit # 18 250 Test Prep Kit # 19 250 Test Prep Kit # 20 250 Test Prep Kit # 21 250 Test Prep Kit # 22 250 Test Prep Kit # 23 250 Test Prep Kit # 24 250 Test Prep Kit # 25 250 Test Prep Kit # 26 250 Test Prep Kit # 27 250 Test Prep Kit # 28 250 Test Prep Kit # 29 250 Test Prep Kit # 30 250 Test Prep Kit # 31 250 Test Prep Kit # 32 250 Test Prep Kit # 33 250 Test Prep Kit # 34 250 Test Prep Kit # 35 250 Test Prep Kit # 36 250 Test Prep Kit # 37 250 Test Prep Kit # 38 250 Test Prep Kit # 39 250 Test Prep Kit # 40 250 Test Prep Kit # 41 250 Test Prep Kit # 42 250 Test Prep Kit # 43 250 Test Prep Kit # 44 250 Test Prep Kit # 45 250 Test Prep Kit # 46 250 Test Prep Kit # 47 250 Test Prep Kit # 48 250 Test Prep Kit # 49 250 Test Prep Kit # 50 250 Test Prep Kit # 51 250 Test Prep Kit # 52 250 Test Prep Kit # 53 250 Test Prep Kit # 54 250 Test Prep Kit # 55 250 Test Prep Kit # 56 250 Test Prep Kit # 57 250 Test Prep Kit # 58 250 Test Prep Kit # 59 250 Test Prep Kit # 60 Part Number 786-2868 05276462001 786-2869 05276489001 786-2870 05276497001 786-2871 05276519001 786-2872 05276527001 786-2873 05276535001 786-2874 05276543001 786-2875 05276551001 786-2876 05276560001 786-2877 05276578001 786-2878 05276586001 786-2879 05276594001 786-2880 05276608001 786-2881 05276616001 786-2882 05276624001 786-2883 05276632001 786-2884 05276659001 786-2885 05276667001 786-2886 05276675001 786-2887 05276683001 786-2888 05276691001 786-2889 05276705001 786-2890 05276713001 786-2891 05276721001 786-2892 05276730001 786-2893 05276748001 786-2894 05276756001 786-2895 05276764001 786-2896 05276772001 786-2897 05276799001 786-2898 05276802001 786-2899 05276829001 786-2900 05276837001 786-3007 05276845001 786-3008 05276853001 786-3009 05276861001 786-3010 05276870001 786-3011 05276888001 786-3012 05276896001 786-3013 05276900001 786-3014 05276918001 786-3015 05276926001 786-3016 05276934001 Product 250 Test Prep Kit # 61 250 Test Prep Kit # 62 250 Test Prep Kit # 63 250 Test Prep Kit # 64 250 Test Prep Kit # 65 250 Test Prep Kit # 66 250 Test Prep Kit # 67 250 Test Prep Kit # 68 250 Test Prep Kit # 69 250 Test Prep Kit # 70 250 Test Prep Kit # 71 250 Test Prep Kit # 72 250 Test Prep Kit # 73 250 Test Prep Kit # 74 250 Test Prep Kit # 75 250 Test Prep Kit # 76 250 Test Prep Kit # 77 250 Test Prep Kit # 78 250 Test Prep Kit # 79 250 Test Prep Kit # 80 250 Test Prep Kit # 81 250 Test Prep Kit # 82 250 Test Prep Kit # 83 250 Test Prep Kit # 84 250 Test Prep Kit # 85 250 Test Prep Kit # 86 250 Test Prep Kit # 87 250 Test Prep Kit # 88 250 Test Prep Kit # 89 250 Test Prep Kit # 90 250 Test Prep Kit # 91 250 Test Prep Kit # 92 250 Test Prep Kit # 93 250 Test Prep Kit # 94 250 Test Prep Kit # 95 250 Test Prep Kit # 96 250 Test Prep Kit # 97 250 Test Prep Kit # 98 250 Test Prep Kit # 99 250 Test Prep Kit # 100 250 Test Prep Kit # 101 250 Test Prep Kit # 102 250 Test Prep Kit # 103 Part Number 786-3017 05276942001 786-3018 05276969001 786-3019 05276977001 786-3020 05276985001 786-3021 05276993001 786-3022 05277019001 786-3023 05277027001 786-3024 05277035001 786-3025 05277043001 786-3026 05277051001 786-3027 05277060001 786-3028 05277078001 786-3029 05277086001 786-3030 05277094001 786-3031 05277108001 786-3032 05277116001 786-3033 05277124001 786-3034 05277132001 786-3035 05277159001 786-3036 05277167001 786-3037 05277175001 786-3038 05277183001 786-3039 05277191001 786-3040 05277205001 786-3041 05277213001 786-3042 05277221001 786-3043 05277230001 786-3044 05277248001 786-3045 05277256001 786-3046 05277264001 786-3047 05277272001 786-3048 05277299001 786-3049 05277302001 786-3050 05277329001 786-3051 05277337001 786-3052 05277345001 786-3053 05277353001 786-3054 05277361001 786-3055 05277370001 786-3056 05277388001 786-3057 05277396001 786-3058 05277400001 786-3059 05277418001 Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 206 <PREV NEXT> Ancillary Reagents | IHC & ISH HOME Product 250 Test Prep Kit # 104 250 Test Prep Kit # 105 250 Test Prep Kit # 106 250 Test Prep Kit # 107 250 Test Prep Kit # 108 250 Test Prep Kit # 109 250 Test Prep Kit # 110 250 Test Prep Kit # 111 250 Test Prep Kit # 112 250 Test Prep Kit # 113 250 Test Prep Kit # 114 250 Test Prep Kit # 115 250 Test Prep Kit # 116 250 Test Prep Kit # 117 250 Test Prep Kit # 118 250 Test Prep Kit # 119 250 Test Prep Kit # 120 250 Test Prep Kit # 121 250 Test Prep Kit # 122 250 Test Prep Kit # 123 250 Test Prep Kit # 124 250 Test Prep Kit # 125 250 Test Prep Kit # 126 250 Test Prep Kit # 127 Part Number 786-3060 05277426001 786-3061 05277434001 786-3062 05277442001 786-3063 05277469001 786-3064 05277477001 786-3065 05277485001 786-3066 05277493001 786-3067 05277507001 786-3068 05277515001 786-3069 05277523001 786-3070 05277531001 786-3071 05277540001 786-3072 05277558001 786-3073 05277566001 786-3074 05277574001 786-3075 05277582001 786-3076 05277604001 786-3077 05277612001 786-3078 05277639001 786-3079 05277647001 786-3080 05277655001 786-3081 05277663001 786-3082 05277671001 786-3083 05277680001 Product 250 Test Prep Kit # 128 250 Test Prep Kit # 129 250 Test Prep Kit # 130 250 Test Prep Kit # 131 250 Test Prep Kit # 132 250 Test Prep Kit # 133 250 Test Prep Kit # 134 250 Test Prep Kit # 135 250 Test Prep Kit # 136 250 Test Prep Kit # 137 250 Test Prep Kit # 138 250 Test Prep Kit # 139 250 Test Prep Kit # 140 250 Test Prep Kit # 141 250 Test Prep Kit # 142 250 Test Prep Kit # 143 250 Test Prep Kit # 144 250 Test Prep Kit # 145 250 Test Prep Kit # 146 250 Test Prep Kit # 147 250 Test Prep Kit # 148 250 Test Prep Kit # 149 250 Test Prep Kit # 150 <PREV NEXT> Part Number 786-3084 05277698001 786-3085 05277701001 786-3086 05277710001 786-3087 05277728001 786-3088 05277736001 786-3089 05277744001 786-3090 05277752001 786-3091 05277779001 786-3092 05277787001 786-3093 05277795001 786-3094 05277809001 786-3095 05277817001 786-3096 05277825001 786-3097 05277833001 786-3098 05277841001 786-3099 05277850001 786-3100 05277868001 786-3101 05277876001 786-3102 05277884001 786-3103 05277892001 786-3104 05277906001 786-3105 05277914001 786-3106 05277922001 Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). www.ventana.com | www.roche.com 207 IHC & ISH | Ancillary Reagents HOME Fixative dispensers Counterstain dispensers Product 250 Test Counterstain # 1 250 Test Counterstain # 2 250 Test Counterstain # 3 250 Test Counterstain # 4 250 Test Counterstain # 5 250 Test Counterstain # 6 250 Test Counterstain # 7 250 Test Counterstain # 8 250 Test Counterstain # 9 250 Test Counterstain # 10 Part Number 771-741 05271720001 771-742 05271738001 771-743 05271746001 771-744 05271754001 771-745 05271762001 771-746 05271789001 771-747 05271797001 771-748 05271819001 771-749 05271827001 771-750 05271835001 Enzyme dispensers Product 250 Test Enzyme # 1 250 Test Enzyme # 2 250 Test Enzyme # 3 250 Test Enzyme # 4 250 Test Enzyme # 5 250 Test Enzyme # 6 250 Test Enzyme # 7 250 Test Enzyme # 8 250 Test Enzyme # 9 250 Test Enzyme # 10 Product 250 Test Fixative # 1 250 Test Fixative # 2 250 Test Fixative # 3 250 Test Fixative # 4 250 Test Fixative # 5 250 Test Fixative # 6 250 Test Fixative # 7 250 Test Fixative # 8 250 Test Fixative # 9 250 Test Fixative # 10 Part Number 771-731 771-732 771-733 771-734 771-735 771-736 771-737 771-738 771-739 771-740 05271614001 05271622001 05271649001 05271657001 05271665001 05271673001 05271681001 05271690001 05271703001 05271711001 Option dispensers Part Number 771-721 771-722 771-723 771-724 771-725 771-726 771-727 771-728 771-729 771-730 05271517001 05271525001 05271533001 05271541001 05271550001 05271568001 05271576001 05271584001 05271592001 05271606001 Product Part Number 250 Test Option # 1 250 Test Option # 2 250 Test Option # 3 250 Test Option # 4 250 Test Option # 5 250 Test Option # 6 250 Test Option # 7 250 Test Option # 8 250 Test Option # 9 250 Test Option # 10 771-751 771-752 771-753 771-754 771-755 771-756 771-757 771-758 771-759 771-760 05271843001 05271851001 05271860001 05271878001 05271886001 05271894001 05271908001 05271916001 05271924001 05271932001 Replacement filters (20 Filters) 772-100 05271959001 Ventana part number in black, Roche item number in blue. The products that appear on this page are IVD (for in vitro diagnostic use). 208 <PREV NEXT> Ancillary Reagents | IHC & ISH HOME <PREV NEXT> www.ventana.com | www.roche.com 209 HOME 210 <PREV NEXT> V ENTANA DIGITAL PATHOLOGY HOME <PREV NEXT> VENTANA Digital Pathology | iScan Coreo Au Slide Scanner 213 Virtuoso Image Management Software 217 www.ventana.com | www.roche.com 211 VENTANA DIGITAL PATHOLOGY HOME 212 <PREV NEXT> iScan Coreo Au Slide Scanner | VENTANA DIGITAL PATHOLOGY HOME <PREV NEXT> iScan Coreo Au Slide Scanner The iScan Coreo Au slide scanner provides high quality brightfield slide scanning with quality image for case review, sharing and telepathology. Paired with our VENTANA Virtuoso software, iScan Coreo Au provides users with a complete digital pathology solution. Image acquisition through customised reporting increases operational efficiencies and productivity in the lab. What’s on YOUR mind? I need to create a digital image archive. • Access virtual image archives for case sharing and collaboration • Reduce slide handling errors • Improve slide availability, portability I need an effective way to review frozen sections. • Use the “Live Mode” feature as a live microscope to view tissue sections • Enable the pathologist to render a review outside of the surgery suite with remote viewing • Reduce turnaround time I need a solution that is easy to adopt and implement into my lab. • Benchtop scanner with a small footprint holding up to 160 slides • Choose from multiple acquisition options to suit your lab’s financial considerations • Enjoy world-class training and support from our industry-leading customer support organisation • Implement and acclimate quickly with easy IT integration www.ventana.com | www.roche.com 213 VENTANA DIGITAL PATHOLOGY | iScan Coreo Au Slide Scanner HOME <PREV Specifications General Characteristics Computer • Intel based PC, dual core, dual Xeon processor • Storage: 160 SATA / 12 GB, CD/DVD Burner • Connectivity: GIGABIT Ethernet ports Computer monitor • Resolution: flat panel high resolution monitor (1920x1200) • Size: 24 inch Input format • 25 mm x 75 mm (1” x 3”) Microscope Slides Slide capacity • 1 to 160 slides using 8 standard Sakura baskets in an integrated rack Automated turret • Turret with support for four microscope objectives Objectives • Olympus 4X (0.1 NA), 10X (0.3 NA), 20X (0.5 NA) and 40X (0.75 NA) Scanning resolution • 2.5 μm/pixel at 4X, 1 μm/pixel at 10X, 0.46 μm/pixel at 20X, 0.23 μm/pixel at 40X Barcode capability • 1D and 2D barcode reading capability Light source • Integrated LED Configuration • Free standing Light scan • Automated barcode reading, tissue identification, auto focus, scanning and image compression Manual scan • User configurable scan area for single or batched slides in manual mode LCD • 5.5” diagonal full colour display 320 x 240 resolution Scan viewing • 24-bit true colour Slide storage format • Customisable to: JPEG 2000, BIF and TIFF Features • Only whole slide scanner with an automated turret with four objectives, allowing optical brightfield scanning at 4X, 10X, 20X and 40X within one batch • Performs volume scanning with up to 15 z-stacks • Live Mode application supports remote microscopy; the iScan Coreo Au can be used as a live, digital microscope to remotely view frozen sections at 1X-40X magnifications and multiple planes • Walk-away automation with 160 slide capacity Environmental Requirements Heat • 400 BTU/Hr idle, 1000 BTU/Hr running Room Temperature • 20ºC to 32ºC (68ºF to 90ºF) Humidity • 10% to 90%, non-condensing Electrical Specifications Voltage • 110-220 VAC Output capacity • 400 Watts (includes light source) Frequency • 50/60 Hz Safety Certifications Compliance • CE, UL Physical Characteristics Size (W x D x H) • 111.76 x 84.07 x 158.50 cm (44.00” x 33.10” x 62.40”) • 34 x 37 x 34 cm (13.5” x 14.5” x 13.5”) Note: VENTANA products are for in vitro diagnostic use for specific applications and are intended for research use only for other applications. 214 NEXT> iScan Coreo Au Slide Scanner | VENTANA DIGITAL PATHOLOGY HOME <PREV NEXT> Better together | Integrate with VENTANA VANTAGE workflow solution to track slides from histology to slide scanning and diagnosis, for comprehensive real-time visibility into your lab’s operation. www.ventana.com | www.roche.com 215 HOME 216 <PREV NEXT> Virtuoso Image Management Software | VENTANA DIGITAL PATHOLOGY HOME <PREV NEXT> Virtuoso Image Management Software Our advanced digital pathology application software supports slide viewing and case management. Virtuoso web-based software manages the digitised slide from scan to sign-out. By combining easy-to-use functionality and a user-friendly interface, this application improves the efficiency and productivity for the practicing pathologist. Virtuoso software and its rolebased portals can be easily adopted in your lab and will support multiple users in telepathology, sharing and managing cases, viewing images and much more for use with VENTANA slide scanners. What’s on YOUR mind? I need a way to review my cases remotely. • Improve slide availability and portability with digital archives • Access cases remotely at any time, from anywhere, with a web-based application • View, manage and archive cases easily I need a solution my entire lab can use effectively. • Address the needs of each person in your workflow with role-based portals • Support the unique roles of pathologists, histotechnologists, lab administrators and clinicians • Improve efficiency within the entire pathology workflow process I need to share my cases for peer reviews and tumour boards. • Share cases with one or more pathologists, with the ability to set user-defined levels of access on a case • Reduce turnaround time by sharing slides digitally • Eliminate glass slide logistics • Use collaboration sessions to share and view case images with colleagues in real time www.ventana.com | www.roche.com 217 VENTANA DIGITAL PATHOLOGY | Virtuoso Image Management Software HOME <PREV Specifications Unique Features • • • • • Quality control module allows the histotechnologist to review slide images prior to releasing them to the pathologist. Side-by-side slide viewing and image synchronisation are available for image comparisons. Intuitive user interface that mirrors pathology workflow allows users to re-arrange the order by which they view cases, specimens and images. A true thin client option eliminates the need to install software. Customise each individual user’s permissions according to individual roles in your lab’s daily workflow. Virtuoso Minimum System Requirements Client operation system • Windows XP SP2 Supported browsers • Internet Explorer 7.0 or 8.0, Mozilla Firefox 3.6.13 RAM • 2 GB Network Connectivity • 10/100 Mbps Ethernet network card Other software requirements • Adobe Acrobat Reader 8.0 for generating reports in PDF Physical Characteristics Applied server specifications: Operating system • Windows 2008 SP2 64 bit Processor • Intel Dual Quad Core RAM • 16 GB Network connectivity • 1 GB Ethernet Network Card Hard drive • RAID 1/RAID 5 Configuration • Hard Drives (2) 250 GB • Hard Drives (3) 1 TB Database • MySQL 5.1 or Oracle v.11g Enterprise edition Note: VENTANA products are for in vitro diagnostic use for specific applications and are intended for research use only for other applications. Better together | Digitise your glass slides using our iScan Coreo Au scanner, quantitate slide images using our Companion Algorithm software and integrate with VENTANA VANTAGE workflow solution to track slides from histology to slide scanning and diagnosis, providing a comprehensive digital pathology solution. 218 NEXT> Virtuoso Image Management Software | VENTANA DIGITAL PATHOLOGY HOME <PREV NEXT> www.ventana.com | www.roche.com 219 HOME 220 <PREV NEXT> HOME <PREV NEXT> Customer Services | Technical Consultation Centre 223 Education and Training 227 www.ventana.com | www.roche.com 221 HOME 222 <PREV NEXT> Technical Consultation Centre | CUSTOMER SERVICES HOME <PREV NEXT> Technical Consultation Centre Our commitment is to provide world-class support in every interaction with our customers. Our highly trained technical professionals offer realtime access to technical and scientific assistance in native English, French, German, Italian and Spanish to support any customer needs. Our vision Our priority is to provide prompt and accurate technical support, assist our customers with information and troubleshooting on VENTANA instruments, reagents and software and create continual positive experiences that result from timely and effective problem resolution. The Technical Consultation Centre works in conjunction with our Investigation and Applications Laboratory to receive technical updates and perform product quality verification. Our goal is to maintain a peerless Customer Support Centre that meets and ultimately exceeds customers’ expectations. Additional information, product images, package inserts and material safety data sheets are now available online for your viewing and printing convenience. Visit our website at www.ventana.com or www.roche.com and follow the links to our online product catalogue. www.ventana.com | www.roche.com 223 CUSTOMER SERVICES | Technical Consultation Centre HOME <PREV Technical Support How to contact us: Monday to Friday: 8:00 am – 5:00 pm (CET and GMT) EMEA fax: +33 (0)4 76 18 51 43 Germany fax: +49 (0)69 97 20 35 00 By phone: Country 224 Toll Phone Toll Free Phone Email Austria +33(0)476761820 strasbourg.kundendienst@ventana.roche.com Belgium +33(0)476761822 Denmark +33(0)476761826 strasbourg.tcceurope@ventana.roche.com Finland +33(0)476761816 strasbourg.tcceurope@ventana.roche.com France +33(0)476761818 Meylan.TCCFrance@roche.com Germany +33(0)476761830 strasbourg.kundendienst@ventana.roche.com Italy +33(0)476761832 Ireland +33(0)476761817 strasbourg.tcceurope@ventana.roche.com Luxembourg +33(0)476761818 strasbourg.tcceurope@ventana.roche.com Netherlands +33(0)476761828 strasbourg.tcceurope@ventana.roche.com Northern Ireland +33(0)476761817 Norway +33(0)476761827 Poland (English) +33(0)476761823 Portugal +33(0)476761813 South Africa +33(0)476761831 Spain +33(0)476761812 Sweden +33(0)476761829 strasbourg.tcceurope@ventana.roche.com Switzerland +33(0)476761819 strasbourg.kundendienst@ventana.roche.com United Kingdom +33(0)476761817 Other EMEA countries (ENGLISH) +33(0)476761825 0 800 79 281 800 620 628 08007 833 119 strasbourg.tcceurope@ventana.roche.com Meylan.TCCItaly@roche.com strasbourg.tcceurope@ventana.roche.com strasbourg.tcceurope@ventana.roche.com strasbourg.tcceurope@ventana.roche.com 800 200 299 strasbourg.tccportugal@ventana.roche.com strasbourg.tcceurope@ventana.roche.com 902 112 476 0800 16 99 850 strasbourg.tccspain@ventana.roche.com strasbourg.tcceurope@ventana.roche.com strasbourg.tcceurope@ventana.roche.com NEXT> Technical Consultation Centre | CUSTOMER SERVICES HOME <PREV NEXT> www.ventana.com | www.roche.com 225 HOME 226 <PREV NEXT> Education and Training | CUSTOMER SERVICES HOME <PREV NEXT> Education and Training Our Training Centre demonstrates our ongoing commitment to providing complete customer support. At the Education and Training Centre, we are committed to making your training as enjoyable and informative as possible; our focus is on standardisation and improvement of the slide-staining process, thereby helping technologists deliver the best results daily in order to provide pathologists with the best diagnostic information. Training programmes, in small classes conducive to efficient learning, are held throughout the year at our comprehensive Training Centre located at our European headquarters in Meylan (France), Mannheim (Germany) and Burgess Hill (UK). All of our training courses are run by trainers highly experienced in IHC or ISH techniques and in VENTANA’s instruments and reagents. Our objective is to provide you with the knowledge, confidence and resources to enable effective optimisation of experimental conditions for faster research and to increase the productivity of your laboratory. www.ventana.com | www.roche.com 227 CUSTOMER SERVICES | Education and Training HOME <PREV Instrument User Training Courses 228 Training Type Objectives Content VENTANA BenchMark GX and VENTANA BenchMark XT systems Induction Part 3 days – Meylan, Mannheim, Burgess Hill F-TRN-107100 Attendees will experience a full presentation of the instrument, the software and all the IHC and ISH products. The objective for each attendee is to be able to use the instrument with all its capabilities upon course completion. Part of the training will be dedicated to the instrument maintenance and decontamination. - Presentation of the VENTANA BenchMark GX and XT systems: features and benefits - Software presentation - Maintenance and decontamination - Function tests/service tests - VENTANA products in IHC - VENTANA products in ISH - Error messages VENTANA BenchMark ULTRA system Induction Part 3 days – Meylan, Mannheim, Burgess Hill F-TRN-107600 Attendees will experience a full presentation of the instrument, the software and all the IHC and ISH products. The objective for each attendee is to be able to use the instrument with all its capabilities upon course completion. Part of the training will be dedicated to the instrument maintenance and decontamination. - Presentation of the VENTANA BenchMark ULTRA: features and benefits - Software presentation - Maintenance and decontamination - Function tests/service tests - VENTANA products in IHC - VENTANA products in ISH NEXT> Education and Training | CUSTOMER SERVICES HOME <PREV NEXT> Advanced IHC / ISH Training Courses Training Type Objectives Content IHC Artefacts and their Resolution 1 day Meylan, Mannheim, Burgess Hill F-TRN-109100 This course brings together all the key parameters affecting immunohistochemistry staining quality. The training curriculum is focused on a comprehensive understanding of the basic theoretical principles of IHC and on the resolution of the most common artefacts. THEORY - Sample preparation: fixation, tissue processing, slide preparation - IHC staining techniques: detection principles - Troubleshooting: definition of staining patterns & artefacts and the possible causes - Controls: positive & negative controls (definition and sources of false positive/negative) CASE STUDIES - Presentations of several staining issues and how they have been solved IHC Protocol Set-up and Optimisation 4 days – Meylan, Mannheim, Burgess Hill F-TRN-107500 This course covers the theory of each step in the IHC technique and all the “protagonists” in the IHC reaction. The participants will learn how to handle the relevant information concerning an antibody (pivotal reagent in IHC staining). The practical part of this course consists in optimising staining protocols for given antibodies on paraffin-embedded tissue samples. The staining result interpretation as well as possible artefacts will be covered during this in-house training session. Finally, great interest will be focused on the Quality Control in IHC, through the use of control tissues (positive and negative controls). THEORY - Tissue preparation: fixation, tissue processing, slide preparation - Antigen: proteins, localisation - Pretreatment: heat, enzyme - Antibody incubation: clone, sensitivity, specificity, incubation time and temperature, working dilution - Chromogenic detection: different detection principles (LSAB, ABC, PAAP, Polymer, Multimer), sensitivity - Dual staining - Controls: positive & negative controls (definition and sources of false positive/negative) - Staining Ancillaries: amplification kit, biotin blocker kit, Neuvision reagents… - Troubleshooting: definition of staining patterns and artefacts. PRACTICE - Antibody technical datasheet: relevant information monoclonal/ polyclonal, staining pattern, target, control tissue, working dilution, tissue pretreatment, storage conditions etc… - Laboratory sessions: • Perform runs with VENTANA and non-VENTANA antibodies on slides brought by participants. • Build a path to reach the optimal staining for a given antibody on the corresponding positive control. www.ventana.com | www.roche.com 229 CUSTOMER SERVICES | Education and Training HOME Technical Training These courses are provided to technical staff such as biomedical engineers having basic technical knowledge. The course teaches participants how to install a VENTANA instrument and how to carry out a basic troubleshooting analysis. Based on this diagnosis, they will be introduced to a list of possible causes and repair possibilities (Level 1 Intervention). Biomedical Engineer Training - Basic This basic technical course provides a Biomedical Engineer with all the knowledge required to perform basic repairs to a VENTANA instrument. At least two Biomedical Engineers are mandatory if the customer chooses the Shared Maintenance agreement. This training can be conducted in one of our training centres in Meylan (France), Burgess Hill (UK), Mannheim (Germany) or on the customer premises. Biomedical Engineer Training - Advanced For customers who would like to carry out all of the maintenance on a VENTANA instrument themselves, this four-day course provides a Biomedical Engineer with the requisite level of expertise. This session must be conducted in one of our training centres in Meylan (France) or Burgess Hill (UK). Additional information on course content, dates and prices is available at: Roche Diagnostics Meylan Education and Training department 2 avenue du Vercors, BP 59, 38242 Meylan Cedex, France Fax : +33 (0)4 76 76 46 60 E-mail : meylan.trainingRTD@roche.com 230 <PREV NEXT> Education and Training | CUSTOMER SERVICES HOME <PREV NEXT> www.ventana.com | www.roche.com 231 HOME 232 <PREV NEXT> HOME <PREV NEXT> Index | www.ventana.com | www.roche.com 233 INDEX | HOME <PREV Index A C a-1-Antichymotrypsin (ACT) (polyclonal) 68 a-1-Antitrypsin (AAT) (polyclonal) 68 a-1-Fetoprotein (AFP) (polyclonal) 69 AAT. See a-1-Antitrypsin 68 ACT. See a-1-Antichymotrypsin 68 ACTH. See Adrenocorticotropin 71 Actin, Muscle (HUC1-1) 69 Actin, Muscle Specific (HHF35) 70 Actin, Smooth Muscle (1A4) 70 Adrenocorticotropin (ACTH) (polyclonal) 71 AEC Detection Kit 49 AFB III Staining Kit 29 AFP. See a-1-Fetoprotein 69 Albumin, FITC 179 Alcian Blue for PAS 23 Alcian Blue Staining Kit 22 Alcian Yellow Staining Kit 29 ALK1 (ALK01) 71 Alu Positive Control Probe 199 Alu Positive Control Probe II 199 Amplification Kit 193 Annexin A1 (MRQ-3) 72 Antibody Diluent 197 Antibody Dilution Buffer 197 PATHWAY c-KIT (CD117) (9.7) 76 c-MET (SP44) 77 C1q, FITC 179 C3d (polyclonal) 77 C3, FITC 180 C4d (polyclonal) 78 C4, FITC 180 CA 19-9 (121SLE) 78 CA 125 (OC125) 79 Calcitonin (polyclonal) 79 Caldesmon (E89) 80 Calponin-1 (EP798Y) 57, 80 Calretinin (SP65) 81 Carcinoembryonic Antigen (CEA31) 81 CD1a (EP3622) 59, 64, 82 CD2 (MRQ-11) 82 CD3 (2GV6) 59, 82 CD4 (SP35) 83 CD5 (SP19) 65, 84 CD7 (SP94) 59, 65, 84 CD8 (SP57) 85 CD10 (SP67) 65, 85 CD14 (EPR3653) 86 CD15 (MMA) 86 CD19 (SP119) 87 CD20 (L26) 87 CD21 (2G9) 88 CD21 (EP3093) 88 CD22 (SP104) 89 CD23 (SP23) 65, 89 CD25 (4C9) 90 CD30 (Ber-H2) 90 CD31 (1A10) 91 CD31 (JC70) 91 CD34 (QBEnd/10) 92 CD43 (L60) 92 CD44 (SP37) 93 CD45 (LCA) (RP2/18) 93 CD45 (LCA) (2B11 & PD7/26) 94 CD45R (MB1) 94 CD45RO (UCHL-1) 95 CD56 (MRQ-42) 95 CD57 (NK-1) 96 CD61 (2f2) 96 CD63 (NKI/C3) 97 CD68 (KP-1) 97 CD71 (MRQ-48) 98 CD79a (SP18) 98 CD99 (O13) 99 CD117. See PATHWAY c-KIT 76 B Basal Cell Cocktail (34βE12+4A4) 72 BCA-225 (Cu-18) 73 bcl-2 (124) 73 bcl-6 (GI191E/A8) 65, 74 BenchMark GX system 45-47 BenchMark XT system 41-43 BenchMark ULTRA system 37-39 Beta-Catenin (14) 57, 74 BG8, Lewisy (F3) 75 Blockers 193 Bluing Reagent 196 BOB.1 (SP92) 75 Breast Diagnostics 57 Bulk Solutions 194–195 234 CD138/syndecan-1 (B-A38) 99 CD163 (MRQ-26) 100 CDX-2 (EPR2764Y) 101 CEA. See Carcinoembryonic Antigen 81 Cell Conditioning 1 (CC1) 184 Cell Conditioning 2 (CC2) 194 Chromogranin A (LK2H10) 101 Collagen Type IV (CIV22) 102 Congo Red Staining Kit 31 Counterstains 196–197 COX-2 (Cyclooxygenase 2) (SP21) 103 Cyclin D1 (SP4-R) 65, 103 Cyclooxygenase 2. See COX-2 103 Cytokeratin (34βE12) 67, 104 Cytokeratin (AE1) 104 Cytokeratin (AE3) 105 Cytokeratin (CAM 5.2) 105 Cytokeratin (Pan) (AE1/AE3 & PCK26) 106 Cytokeratin 5/6 (D5/16B4) 57, 63, 67, 106 Cytokeratin 7 (SP52) 107 Cytokeratin 8 (35betaH11) 107 Cytokeratin 8 & 18 (B22.1 & B23.1) 108 Cytokeratin 10 (SP99) 108 Cytokeratin 14 (LL002) 109 Cytokeratin 17 (SP95) 109 Cytokeratin 19 (A53-B/A2.26) 110 Cytokeratin 20 (SP33) 110 D Derm Diagnostics 59 Desmin (DE-R-11) 111 Detection chemistries 49-53 AEC Detection Kit 49 ISH iVIEW Blue Detection Kit 52 ISH iVIEW Blue Plus Detection Kit 52 iVIEW DAB Detection Kit 50 ultraView Alkaline Phosphatase (AP) Red ISH Detection Kit 51 ultraView Red ISH DIG Detection Kit 51 ultraView SISH Detection Kit 53 ultraView SISH DNP Detection kit 53 ultraView Universal Alkaline Phosphatase Red Detection Kit 51 ultraView Universal DAB Detection Kit 50 Diastase Kit 24 Diluents 197 DOG1 (SP31) 111 NEXT> | INDEX HOME <PREV E G I E-Bar II Barcode Slide Label System 39-43 EBER Positive Specimen Slides 200 INFORM EBER Probe 192 E-Cadherin (36) 112 E-Cadherin (EP700Y) 112 EGFR (3C6) 113 EGFR (5B7) 113 EGFR ISH Xenograft Control Slides 200 INFORM EGFR Probe Assay 187 Elastic Staining Kit 25 EMA (Epithelial Membrane Antigen) (E29) 114 Endogenous Biotin Blocking Kit 193 Enzymes 198 Ep-CAM/Epithelial Specific Antigen (Ber-EP4) 115 Epidermal Growth Factor Receptor. See EGFR 113 Epithelial Membrane Antigen. See EMA 114 Epithelial Related Antigen (MOC-31) 63, 116 Epithelial Specific Antigen. See Ep-CAM 115 ER. See Estrogen Receptor 117 ERG (EPR3864) 116 Estrogen Receptor (ER) (SP1) 117 EZ Prep (10X) 195 Galectin-3 (9C4) 120 Gastrin (polyclonal) 120 GCDFP-15 (EP1582Y) 57, 121, 178 GFAP (EP672Y) 121 GH (Polyclonal) 122 Giemsa Staining Kit 31 Glial Fibrillary Acidic Protein. See GFAP 121 Glucagon (polyclonal) 122 GLUT-1 (polyclonal) 123 Glycophorin A (GA-R2 & HIR2) 1213 Glypican-3 (1G12) 124 Glypican 3 (GC33) 124 GMS II Staining Kit 30 GMS Staining Kit 30 Granzyme B (polyclonal) 125 Growth Hormone. See GH 122 IgA, FITC 181 IgA (polyclonal) 132 IgD (polyclonal) 133 IGF1R ISH Xenograft Slides 201 INFORM IGF1R Probe Assay 188 IGF-1R. See Insulin Growth Factor-1 Receptor IgG, FITC 181 IgG (polyclonal) 133 IgM, FITC 181 IgM (polyclonal) 133 Immunofluorescence antibodies 179–182 Immunoglobulin A. See IgA 181 Immunoglobulin G. See IgG 133 Immunoglobulin M. See IgM 133 Inhibin, alpha (R1) 134 Insulin (polyclonal) 135 Insulin Growth Factor-1 Receptor (G11) 135 Iron Staining Kit 32 iScan Coreo Au Slide Scanner 213-214 ISH Block 194 ISH iVIEW Blue Detection Kit 52 ISH iVIEW Blue Plus Detection Kit 52 ISH Negative Control 199 ISH Protease 1 198 ISH Protease 2 198 ISH Protease 3 199 iVIEW DAB Detection Kit 50 F Factor VIII Related Antigen (polyclonal) 117 Factor XIIIa (AC-1A1) 118 Factor XIIIa (EP3372) 59, 118, 179 Fascin (55k-2) 119 Fibrinogen, FITC 180 FITC Primary Antibodies Albumin, FITC 179 C1q, FITC 179 C3, FITC 180 C4, FITC 180 Fibrinogen, FITC 180 IgA, FITC 181 IgG, FITC 181 IgM, FITC 181 Kappa, FITC 182 Lambda, FITC 182 Follicle Stimulating Hormone. See FSH 119 FSH (polyclonal) 119 H hCG. See Human Chorionic Gonadotropin 131 HBcAg. See Hepatitis B Virus Core Antigen 183 HBsAg. See Hepatitis B Virus Surface Antigen 183 Helicobacter pylori (polyclonal) 61, 125 Hematoxylin 22, 23, 24, 25, 26, 27, 33, 197 Hematoxylin II 197 Hepatitis B Virus Core Antigen (polyclonal) 183 Hepatitis B Virus Surface Antigen (S1-210) 183 Hepatocyte Specific Antigen. See HSA 130 PATHWAY HER-2 4 in 1 Control Slides 200 HER2 DUAL ISH 3-in-1 Xenograft Slides 201 PATHWAY HER-2/neu (4B5) 126, 127 VENTANA HER2 DNA Probe Assay 186 INFORM HER2 Dual ISH DNA Probe Cocktail Assay 185 VENTANA HER-2/neu (4B5) 128 Herpes Simplex Virus I (polyclonal) 128 Herpes Simplex Virus II (polyclonal) 129 H&E staining 25 HGAL (MRQ-49) 129 HHV-8 (13B10) 130 hPL. See Human Placental Lactogen 131 HPV 3 in 1 System Control Slides 201 HPV Family 6 System Control Slides (B) 201 INFORM HPV II Family 6 Probe (B) 191 INFORM HPV III Family 16 Probe (B) 191 HSA (0CH1E5) 130 Human Chorionic Gonadotropin (polyclonal) 131 Human Herpes Virus Type 8. See HHV-8 130 Human Placental Lactogen (polyclonal) 131 HybReady Solution 197 NEXT> J Jones H&E Staining Kit 25 Jones Light Green Staining Kit 26 K Kappa (polyclonal) 135 Kappa, FITC 182 Kappa Positive Specimen Slides 202 INFORM Kappa Probe 192 Ki-67 (30-9) 136 Ksp-Cadherin (MRQ-33) 136 Keratin (34βE12). See Cytokeratin (34βE12) 104 Keratin (AE1). See Cytokeratin (AE1) 104 Keratin (AE3). See Cytokeratin (AE3) 105 Keratin (CAM 5.2). See Cytokeratin (CAM 5.2) 105 Keratin (Pan) (AE1/AE3 & PCK26). See Cytokeratin (Pan) (AE1/AE3 & PCK26) 106 Keratin 5/6 (D5/16B4). See Cytokeratin 5/6 (D5/16B4) 106 Keratin 7 (SP52). See Cytokeratin 7 (SP52) 107 Keratin 8 (35betaH11). See Cytokeratin 8 (35betaH11) 107 www.ventana.com | www.roche.com 235 INDEX | HOME Keratin 8 & 18 (B22.1 & B23.1). See Cytokeratin 8 & 18 (B22.1 & B23.1) 108 Keratin 10 (SP99). See Cytokeratin 10 (SP9) 108 Keratin 14 (LL002). See Cytokeratin 14 (LL00) 109 Keratin 17 (SP95). See Cytokeratin 17 (SP95) 109 Keratin 19 (A53-B/A2.26). See Cytokeratin 19 (A53-B/A2.26) 110 Keratin 20 (SP33). See Cytokeratin 20 (SP33) 110 MUC1 (H23) 145 MUC2 (MRQ-18) 145 MUC5AC (MRQ-19) 146 MUC6 (MRQ-20) 147 Mucicarmine Staining Kit 22 MUM1 (MRQ-43) 65, 148 Myeloperoxidase (polyclonal) 148 Myogenin (F5D) 149 Myoglobin (polyclonal) 149 Myosin, Smooth Muscle (SMMS-1) 150 L Lambda (polyclonal) 137 Lambda, FITC 182 Lambda Positive Specimen Slides 202 INFORM Kappa Probe 192 LCA. See CD45 94 LH. See Luteinizing Hormone 138 Light Green for PAS 24 Liquid Coverslip (High Temperature) 195 Liquid Coverslip (Low Temperature) 33 LMO2 (1A9-1) 137 Lung Diagnostics 63 Luteinizing Hormone (polyclonal) 132 Lymphoma Diagnostics 65 Lysozyme (polyclonal) 138 M Macrophage (HAM-56) 139 Mammaglobin (31A5) 139 MART-1/melan A (A103) 140 Melanoma Associated Antigen (KBA.62) 59, 141 Melanoma Associated Antigen (PNL2) 141 Melanosome (HMB45) 142 Mesothelial Cell (HBME-1) 142 MET ISH Xenograft Control Slides 202 INFORM MET Probe Assay 159 MITF (C5/D5) 143 MLH1 (M1) 143 Molecular Probes 185 INFORM EBER Probe 192 INFORM EGFR Probe Assay 187 VENTANA HER2 DNA Probe Assay 186 INFORM HER2 Dual ISH DNA Probe Cocktail Assay 185 INFORM HPV II Family 6 Probe (B) 191 INFORM HPV III Family 16 Probe (B) 191 INFORM IGF1R Probe Assay 188 INFORM Kappa Probe 192 INFORM Lambda Probe 192 INFORM MET Probe Assay 189 INFORM TOP2A Probe Assay 190 MPO. See Myeloperoxydase 148 MSH2 (G219-1129) 144 MSH6 (44) 144 236 N Napsin A (Polyclonal) 150 Negative Control Mouse Ig (MOPC21) 151 Negative Control Probe 199 Negative Control Rabbit Ig 151 Negative Control Reagents 199 Nerve Growth Factor Receptor (MRQ-21) 151 Neurofilament (2F11) 152 Neuron Specific Enolase. See NSE 152 NeuVision Blocking Reagent 194 NeuVision Nuclear Stain Kit 197 NexES Special Stainer 19 Heavy Metal Extraction System 21 Vapor Extraction Filter 21 Waste Container with Sealed Cap 21 NGFR. See Nerve Growth Factor Receptor 151 NSE (E27) 152 O Oct-2 (MRQ-2) 153 Oct-4 (MRQ-10) 154 OptiView Amplification Kit 193 OptiView DAB IHC Detection Kit 50 P p21WAF1 (DCS-60.2) 154 p27kip1 (SX53G8) 155 p53 (Bp-53-11) 155 p53 (DO-7) 156 p63 (4A4) 57, 61, 156 p120 (98) 57, 157 Pan. See Cytokeratin (Pan) (AE1/AE3 & PCK26) 106 Parathyroid Hormone (MRQ-31) 157 PAS Staining Kit 23 PAX5 (SP34) 158 PD-1 (MRQ-22) 57, 159 Perforin (MRQ-23) 160 PGP 9.5 (polyclonal) 160 <PREV PHH3. See Phosphohistone-H3 161 Phosphohistone-H3 (polyclonal) 161 Placental Alkaline Phosphatase (NB10) 161 PLAP. See Placental Alkaline Phosphatase 161 PMS2 (EPR3947) 162 Pneumocystis jiroveci (carinii) (3F6) 162 Podoplanin (D2-40) 163 Positive control reagents 189 PR. See Progesterone Receptor 163 Progesterone Receptor (1E2) 163 Prolactin (polyclonal) 164 Prostate Diagnostics 67 Prostate Specific Antigen. See PSA 22 Prostatic Acid Phosphatase. See PSAP 22 Protease 1 198 Protease 2 198 Protease 3 198 Protein Gene Product 9.5. See PGP 9.5 160 PSA (ER-PR8) 184 PSA (polyclonal) 164 PSAP (PASE/4LJ) 165 PTH. See Parathyroid Hormone 157 R RCC. See Renal Cell Carcinoma 165 Reaction Buffer (10X) 195 Red Counterstain II 195 Renal Cell Carcinoma (RCC) (PN-15) 165 Reticulum II Staining Kit 26 S S100 (4C4.9) 166 S100 (polyclonal) 166 Simian Virus 40. See SV40 168 Smoothelin (R4A) 167 Somatostatin (polyclonal) 163 Special Stains 19-30 AFB III Staining Kit 29 Alcian Blue for PAS 23 Alcian Blue Staining Kit 22 Alcian Yellow Staining Kit 29 Congo Red Staining Kit 31 Diastase Kit 24 Elastic Staining Kit 25 Giemsa Staining Kit 31 GMS II Staining Kit 30 GMS Staining Kit 30 Iron Staining Kit 32 Jones H&E Staining Kit 25 Jones Light Green Staining Kit 26 Light Green for PAS 24 Mucicarmine Staining Kit 22 PAS Staining Kit 23 Reticulum II Staining Kit 26 Steiner Staining Kit 30 Trichrome II Blue Staining Kit 27 NEXT> | INDEX HOME Trichrome III Blue Staining Kit 27 Trichrome III Green Staining Kit 28 Special Stains Cleaning Kit 33 Special Stains Wash (10x) 33 Specimen/Control Slides 200 EBER Positive Specimen Slides 200 EGFR ISH Xenograft Control Slides 200 HER2 3-in-1 Xenograft Control Slides 201 PATHWAY HER-2 4 in 1 Control Slides 200 HER2 DUAL ISH 3-in-1 Xenograft Slides 201 HPV 3 in 1 System Control Slides 201 HPV Family 6 System Control Slides (B) 201 IGF1R ISH Xenograft Slides 201 Kappa Positive Specimen Slides 202 Lambda Positive Specimen Slides 202 MET ISH Xenograft Control Slides 202 TOP2A ISH Xenograft Control Slides 202 Spectrin (RBC2/3D5) 168 SV 40 (MRQ-4) 168 SSC (10X) 196 Steiner Cleaning Kit 30 Steiner Staining Kit 30 SYMPHONY H&E system 13, 14, 15 OPTISURE Coverslips 15 SYMPHONY B 15 SYMPHONY C 15 SYMPHONY Clear 15 SYMPHONY D 15 SYMPHONY Desiccant Filter 15 SYMPHONY N1 15 SYMPHONY N2+ 15 SYMPHONY N2+ Cleaning Kit 15 SYMPHONY Tray Kit 15 SYMPHONY W 15 Synaptophysin (MRQ-40) 169 <PREV T V T-bet (MRQ-46) 169 TAG-72 (B72.3) 57, 170 Tartrate-Resistant Acid Phosphatase. See TRAcP 173 TdT (polyclonal) 170 Terminal Deoxynucleotidyl Transferase. See TdT 170 Thymidine Phosphorylase (P-GF.44C) 171 Thyroglobulin (2H11+6E1) 171 Thyroid Stimulating Hormone (polyclonal) 172 Thyroid Transcription Factor-1 (8G7G3/1) 172 TOP2A ISH Xenograft Control Slides 202 INFORM TOP2A Probe Assay 190 Topoisomerase IIa (JS5B4) 173 TRAcP (9C5) 173 Trichrome II Blue Staining Kit 27 Trichrome III Blue Staining Kit 27 Trichrome III Green Staining Kit 28 Tryptase (G3) 174 TSH. See Thyroid Stimulating Hormone 172 TTF-1. See Thyroid Transcription Factor-1 172 Tyrosinase (T311) 174 VANTAGE. See VANTAGE workflow solution 3 VANTAGE workflow consulting 7 VANTAGE workflow management suite 4 VANTAGE workflow solution 3, 4, 15, 43, 48 VANTAGE Lean Workflow Solution 8 Villin (CWWB1) 175 Vimentin (V9) 176 Vimentin (Vim 3B4) 176 Virtuoso image management software 217–218 NEXT> W Workflow Consulting 7, 8 WT1 (6F-H2) 63, 177 Z ZAP-70 (2F3.2) 63, 177 U ULTRA Cell Conditioning 1 (ULTRA CC1) 194 ULTRA Cell Conditioning 2 (ULTRA CC2) 194 ULTRA LCS 195 ultraView Red ISH DIG Detection Kit 51 ultraView Silver Wash II 196 ultraView SISH DNP detection kit 53 ultraView Universal Alkaline Phosphatase Red Detection Kit 51 ultraView Universal DAB Detection Kit 50 Uroplakin III (SP73) 175 User-fillable dispensers/Prep Kits 230-208 50 Test Prep Kits 203 100 Test Prep Kits 203 250 Test Prep Kits 203 Counterstain Dispenser 208 Enzyme Dispensers 208 Fixative Dispensers 208 Option Dispensers 208 www.ventana.com | www.roche.com 237 HOME 238 <PREV NEXT> HOME <PREV Roche Diagnostics International Ltd. CH-6343 Rotkreuz Switzerland www.roche.com www.ventana.com Roche Diagnostics VENTANA product portfolio © 2011 Ventana Medical Systems, Inc. and Roche Diagnostics International Ltd. VENTANA, the VENTANA logo, BENCHMARK, CONFIRM, DISCOVERY, INFORM, NexES, OPTISURE, PATHWAY, SYMPHONY, ultraView and VANTAGE are trademarks of Roche. All other trademarks are the properties of their respective owners. E2123 1011A 06562604001 third edition October, 2011 Roche Diagnostics VENTANA Product Portfolio | Third Edition