PSA INSTRUCTIONS FOR USE

Transcription

Intended For Use in the United States
PSA
INSTRUCTIONS FOR USE
VITROS Immunodiagnostic Products
PSA Reagent Pack
VITROS Immunodiagnostic Products
PSA Calibrators
680 1756
193 3027
Intended Use
For in vitro diagnostic use only.
VITROS Immunodiagnostic Products PSA Reagent Pack
For the quantitative measurement of prostate-specific antigen (PSA) concentration in human serum and plasma (EDTA or
heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the
VITROS 5600 Integrated System to aid in the management of patients with prostate cancer.
VITROS Immunodiagnostic Products PSA Calibrators
For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System
and the VITROS 5600 Integrated System for the quantitative measurement of PSA in human serum and plasma (EDTA or
heparin).
Summary and Explanation of the Test
Prostate cancer is the most common type of cancer found in men in the United States, and is the second leading cause of
cancer deaths among American men.1 As with other cancers, it is more successfully treated if diagnosed early.
PSA is a glycoprotein with a molecular weight of approximately 34,000 Daltons.2 It is found in normal, benign hyperplastic and
malignant prostatic tissue as well as in prostatic fluid and seminal plasma.3 In serum, PSA exists in several different forms.
However, only free and alpha-1-antichymotrypsin (ACT)-complexed PSA are immunologically active. The VITROS PSA test
measures total PSA (free and ACT-complexed PSA).
Elevated serum PSA concentrations are found in men with prostate cancer, benign prostatic hypertrophy (BHP) or
inflammatory conditions of other adjacent genitourinary tissues, but not in apparently healthy men or in men with cancers other
than prostate cancer.4 Measurement of serum PSA by itself is not recommended as a screening procedure for the diagnosis of
cancer because elevated PSA levels are also observed in patients with benign prostatic hypertrophy.
When employed for the management of prostate cancer patients, serial measurement of PSA is useful in detecting residual
tumor and recurrent cancer after radical prostatectomy.5,6 PSA has been demonstrated to be an accurate marker for monitoring
advancing clinical stage in untreated patients7 and for monitoring response to therapy by radical prostatectomy, radiation
therapy and anti-androgen therapy.6,8,9 PSA is also important in determining the potential and actual effectiveness of surgery or
other therapies.
Principles of the Procedure
The VITROS PSA test is an equimolar test for the detection of free and ACT-complexed PSA. The VITROS PSA test is
performed using the VITROS PSA Reagent Pack and VITROS PSA Calibrators on the VITROS ECi/ECiQ Immunodiagnostic
Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System using Intellicheck®
Technology. An immunometric test technique is used. PSA present in the sample reacts simultaneously with two biotinylated
antibodies (both mouse monoclonal anti-PSA) and a horseradish peroxidase (HRP)-labeled antibody conjugate (goat
polyclonal anti-PSA). The antigen-antibody complex is captured by streptavidin on the wells. Unbound materials are removed
by washing.
The bound HRP conjugate is measured by a luminescent reaction.10 A reagent containing luminogenic substrates (a luminol
derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes
the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the
level of light produced and prolongs its emission. The light signals are read by the system. The amount of HRP conjugate
bound is directly proportional to the concentration of PSA present in the sample.
Test Type
Immunometric
Version 6.0
System
ECi/ECiQ, 3600,
5600
Incubation Time
Time to first
result
Test
Temperature
Reaction
Sample Volume
29 minutes
37 minutes
37 °C
15 µL
Pub. No. GEM1115A_EN_US
1
PSA
Reaction Scheme
Warnings and Precautions
WARNING:
Potentially Infectious Material
Use caution when handling material of human origin. Consider all samples
potentially infectious. No test method can offer complete assurance that
hepatitis B virus, hepatitis C virus (HCV), human immunodeficiency virus
(HIV 1+2) or other infectious agents are absent. Handle, use, store and dispose
of solid and liquid waste from samples and test components, in accordance with
procedures defined by appropriate national biohazard safety guideline or
regulation (e.g. CLSI document M29).11
WARNING:
Contains 2-Chloroacetamide (CAS 79-07-2)
The VITROS PSA Reagent Pack and VITROS PSA Calibrators contain
2-Chloroacetamide. R43: May cause sensitization by skin contact. S24: Avoid
contact with skin. S37: Wear suitable gloves.
Reagents
Reagent Pack Contents
1 reagent pack containing:
• 100 coated wells (streptavidin, bacterial; binds ≥3 ng biotin/well)
• 8.7 mL conjugate reagent (HRP-goat polyclonal anti-PSA, binds ≥40.5 ng PSA/mL) in buffer with antimicrobial agent,
bovine serum albumin and bovine gamma globulin
• 8.7 mL biotinylated antibody reagent (two biotin-mouse monoclonal anti-PSA antibodies, binds ≥40.5 ng PSA/mL) in buffer
with antimicrobial agent, bovine serum albumin and bovine gamma globulin
Reagent Pack Handling
•
•
•
2
The reagent pack is supplied ready for use.
The reagent pack contains homogeneous liquid reagents that do not require shaking or mixing prior to loading onto the
system.
Handle the reagent pack with care. Avoid the following:
−
allowing condensation to form on the pack
−
causing reagents to foam
−
agitation of the pack
Version 6.0
PSA
Reagents
Reagent Pack Storage and Preparation
Reagent
Unopened
Opened
Opened
•
•
•
•
Storage Condition
Refrigerated
2–8 °C (36–46 °F)
3600/5600:
System turned on
On system
System turned on
ECi/ECiQ
(Lot 2590 and above):
On system
3600/5600:
2–8 °C (36–46 °F)
Refrigerated
2–8 °C (36–46 °F)
ECi/ECiQ
(Lot 2590 and above):
Refrigerated
Stability
expiration date
≤4 weeks
≤8 weeks
≤4 weeks
≤8 weeks
The VITROS PSA Reagent Pack is suitable for use until the expiration date on the carton when stored and handled as
specified. Do not use beyond the expiration date.
Do not freeze unopened reagent packs.
Load reagent packs directly from refrigerated storage to minimize condensation.
Store opened refrigerated reagent packs in a sealed reagent pack storage box that contains dry desiccant.
Calibrator Contents
•
•
•
•
1 set of VITROS PSA Calibrators 1, 2, and 3 (human PSA in buffer with antimicrobial agent and bovine serum albumin,
1.75 mL); nominal values 0; 1.25 and 55 ng PSA/mL
Lot calibration card
Protocol card
24 calibrator bar code labels (8 for each calibrator)
Calibrator Handling
•
•
Use only with reagent packs of the same lot number. Mix thoroughly by inversion and bring to 15–30 °C (59–86 °F) before
use. Each pack contains sufficient for a minimum of 6 determinations of each calibrator.
Handle calibrators in stoppered containers to avoid contamination and evaporation. To avoid evaporation, limit the amount
of time calibrators are on the system. Refer to the operating instructions for your system. Return to 2–8 °C (36–46 °F) as
soon as possible after use, or load only sufficient for a single determination.
Calibrator Storage and Preparation
Calibrator
Unopened
Opened
Opened
•
•
•
•
Version 6.0
Storage Condition
Refrigerated
2–8 °C (36–46 °F)
Refrigerated
2–8 °C (36–46 °F)
Frozen
-20 °C (-4 °F)
Stability
expiration date
≤12 weeks
≤12 weeks
VITROS PSA Calibrators are supplied ready for use.
The VITROS PSA Calibrators are suitable for use until the expiration date on the carton when stored and handled as
specified. Do not use beyond the expiration date.
Opened calibrators may be stored frozen (with no more than 1 freeze-thaw cycle).
The VITROS PSA test uses 15 µL of calibrator for each determination. The VITROS PSA Calibrators may be used directly
on the VITROS Immunodiagnostic and VITROS Integrated Systems. Alternatively, transfer an aliquot of each calibrator into
a sample container (taking account of the minimum fill volume of the container), which may be bar coded with the labels
provided. For details on minimum fill volume of sample cups or containers, refer to the operating instructions for your
system.
3
PSA
Specimen Collection, Preparation and Storage
Patient Preparation
No special patient preparation is necessary.
Specimens Recommended
•
•
•
Serum
Heparin plasma
EDTA plasma
Specimens Not Recommended
Do not use turbid specimens. Turbidity in specimens may affect test results.
Special Precautions
Important:
Certain collection devices have been reported to affect other analytes and tests.12
Owing to the variety of specimen collection devices available, Ortho-Clinical
Diagnostics is unable to provide a definitive statement on the performance of its
products with these devices. Confirm that your collection devices are compatible with
this test.
Specimen Collection and Preparation
•
•
•
Collect specimens using standard procedures.13,14
Thoroughly mix samples by inversion and bring to 15–30 °C (59–86 °F) before use.
The VITROS PSA test uses 15 µL of sample for each determination. This does not take account of the minimum fill volume
of the chosen sample container. For details on minimum fill volume of sample cups or containers, refer to the operating
instructions for your system.
Handling and Storage Conditions
•
•
•
•
•
Handle samples in stoppered containers to avoid contamination and evaporation.
The amount of time samples are on the system prior to analysis should be limited to avoid evaporation. Refer to the
operating instructions for your system.
Return to 2–8 °C (36–46 °F) as soon as possible after use, or load sufficient for a single determination.
Serum and plasma samples may be stored for up to 7 days at 2–8 °C (36–46 °F) or 4 weeks at -20 °C (-4 °F).
Avoid repeated freeze-thaw cycles.
Testing Procedure
Materials Provided
•
•
VITROS Immunodiagnostic Products PSA Reagent Pack
VITROS Immunodiagnostic Products PSA Calibrators
Materials Required but not Provided
•
•
•
•
•
VITROS Immunodiagnostic Products Signal Reagent
VITROS Immunodiagnostic Products Universal Wash Reagent
VITROS Immunodiagnostic Products High Sample Diluent B
Quality control materials
VITROS Immunodiagnostic Products Reagent Pack Storage Box (optional) with desiccant
Operating Instructions
Check the inventory regularly to aid the management of reagents and ensure that sufficient VITROS Signal Reagent, VITROS
Universal Wash Reagent and calibrated reagent lots are available for the work planned. When performing panels of tests on a
single sample, ensure that the sample volume is sufficient for the tests ordered.
For detailed information refer to the operating instructions for your system.
NOTE:
4
Do not use visibly damaged product.
Version 6.0
PSA
Calibration
Sample Dilution
Serum or plasma (EDTA or heparin) samples with concentrations greater than the measuring range may be automatically
diluted on the system up to 20-fold (1 part sample with 19 parts diluent)] by the VITROS Immunodiagnostic and VITROS
Integrated Systems with the VITROS High Sample Diluent B Reagent Pack prior to test. Refer to the VITROS High Sample
Diluent B Reagent Pack instructions for use.
Default Test Name
The default test name which will appear on patient reports is PSA. The default short name that will appear on the test selection
menus and laboratory reports is PSA. These defaults may be reconfigured, if required. For detailed information, refer to the
operating instructions for your system.
Calibration
Calibration Procedure
•
Calibration is lot specific; reagent packs and calibrators are linked by lot number. Reagent packs from the same lot may
use the same calibration.
• A Master Calibration (a dose response curve covering the full calibration range) is established for each new reagent lot.
Concentrations for the linked lot of calibrators are determined from the Master Calibration.
• Ensure that the Master Calibration for each new reagent lot is available on your system.
• Process calibrators in the same manner as samples. Calibration need not be programmed if bar code labels are used; load
the calibrators in any order, calibration will be initiated automatically.
• When the calibrators are processed the signal expected for each calibrator is compared against the actual signal obtained.
The Master Calibration is then rescaled to reflect the differences between the actual and expected signals. The validity of
this calibration curve is assessed against a range of quality parameters, and if acceptable, it is stored for use with any
reagent pack of that lot.
• The quality of calibration cannot be completely described by a single parameter. The calibration report should be used in
conjunction with acceptable control values to determine the validity of the calibration.
• Recalibration is required after a pre-determined calibration interval, or when a different reagent lot is loaded.
• Calibration results are assessed against a range of quality parameters. Failure to meet any of the defined quality parameter
ranges will be coded in the calibration report. For actions to be taken following a failed calibration refer to the operating
instructions for your system.
Refer to the operating instructions for your system for detailed instructions on the calibration process.
When to Calibrate
• Calibrate when the reagent pack and calibrator lot changes.
• Calibrate every 28 days.
• After specified service procedures have been performed.
• If quality control results are consistently outside of your acceptable range.
For additional information on when to calibrate, refer to the operating instructions for your system.
Traceability of Calibration
Calibration of the VITROS PSA test is traceable to in-house reference calibrators, which have been value assigned to correlate
to another commercially available test.
Calibration Model
A modified four-parameter logistic curve fit function is used to construct the Master Calibration. The calibration process
rescales the Master Calibration to establish a valid stored curve for the VITROS Immunodiagnostic and VITROS Integrated
Systems.
Measuring (Reportable) Range
System
3600
5600
ECi/ECiQ (Lot 2740 and above)
ECi/ECiQ (Lot 2739 and below)
*
**
Measuring (Reportable) Range
0.064*–100 ng/mL
0.000**–100 ng/mL
Lower limit of measuring range reported by the system software is based on the Limit of Detection.
Lower limit of measuring range reported by the system software is 0 ng/mL.
The lower limit reported by the system can be reconfigured if desired. For details on how to reconfigure the lower limit refer to
the operating instructions for your system.
Version 6.0
5
PSA
Quality Control
Quality Control Material Selection
Controls containing suitable levels of PSA are recommended for use with the VITROS Immunodiagnostic and VITROS
Integrated Systems. The performance of commercial control fluids should be evaluated for compatibility with this test before
they are used for quality control.
Control materials may show a difference when compared with other PSA methods if they contain high concentrations of
preservatives, stabilizers, or other nonphysiological additives, or otherwise depart from a true human sample matrix.
Appropriate quality control value ranges must be established for all quality control materials used with the VITROS PSA test.
Quality Control Procedure Recommendations
•
•
•
Good laboratory practice requires that controls be processed to verify the performance of the test.
Choose control levels that check the clinically relevant concentrations.
To verify system performance, analyze control materials:
−
After calibration
−
According to local regulations or at least once each day that the test is being performed
−
After specified service procedures are performed
If quality control procedures within your laboratory require more frequent use of controls, follow those procedures.
• Analyze quality control materials in the same manner as patient specimens.
• If control results fall outside your acceptable range, investigate the cause before deciding whether to report patient results.
• Refer to published guidelines for general quality control recommendations.15
For more detailed information, refer to the operating instructions for your system.
Quality Control Material Preparation and Storage
Refer to the manufacturer’s product literature for preparation, storage, and stability information.
Results
Results are automatically calculated by the VITROS Immunodiagnostic and VITROS Integrated Systems.
Reporting Units
Analyte results are quoted in units of ng/mL.
Limitations of the Procedure
Known Interferences
The VITROS PSA test was evaluated for interference consistent with CLSI document EP7.16 Commonly encountered
substances were tested on 2 lots of reagents. Of the compounds tested, acetaminophen and hemoglobin may interfere with the
VITROS PSA test resulting in a positive bias as shown in the table below.
Refer to “Specificity” for a list of other compounds tested that did not show interference.
Units = ng/mL
Interferent
Acetaminophen
Hemoglobin
Hemoglobin
Hemoglobin
*
**
NOTE:
6
Interferent Concentration
1323 µmol/L
200 µg/mL
0.124 mmol/L 200 mg/dL
Analyte Conc.*
4.30
≤0.03
≤0.03
≤0.03
Bias**
0.335
0.118
0.270
0.390
Average test concentration of replicate determinations using two different lots of reagent.
Estimate of the average difference observed.
These results are representative. The degree of interference at concentrations other
than those listed might not be predictable from these results. Other interfering
substances may be encountered in the patient population.
Version 6.0
PSA
Expected Values and Interpretation of Results
Other Limitations
•
•
•
•
•
•
•
•
The results from this or any other diagnostic test should be used and interpreted only in the context of the overall clinical
picture.
Heterophilic antibodies in serum or plasma samples may cause interference with immunoassay.17 These antibodies may
be present in blood samples from individuals regularly exposed to animals or who have been treated with animal serum
products. Results which are inconsistent with clinical observations indicate the need for additional testing.
Biotin levels in serum remain elevated for up to 24 hours after oral or intravenous biotin administration.18
The VITROS PSA test has no high dose hook effect up to 50,000 ng/mL.
Different test methods cannot be used interchangeably. PSA results in a given patient sample determined with different
tests and from different manufacturers can vary due to differences in test methods and reagent specificity. A change to a
different method during serial monitoring of a patient should be accompanied by additional sequential testing to confirm
baseline values. The results reported by the laboratory to the physician must include the identity of the PSA test used.
Serial test results obtained with the VITROS PSA test, in patients who are clinically free of disease, should be used in
conjunction with all relevant information derived from diagnostic tests, physical examination, and full medical history in
accordance with appropriate patient management procedures.
For changes in tumor marker concentrations during therapy:19
– Progressive disease is defined by an increase of at least 25%. Sampling should be repeated within two to four weeks
for additional evidence.
– Partial remission is defined as a decrease of at least 50% in the tumor marker concentration.
Certain drugs and clinical conditions are known to alter PSA concentrations in vivo. For additional information, refer to one
of the published summaries.20-22
Expected Values and Interpretation of Results
It is recommended that each laboratory establish its own expected values for the population it serves.
Distribution of Results by Clinical Category
No. of
Subjects
<4 ng/mL
>4 ng/mL
200
167
198
166
2
1
Non-Malignant Conditions
BPH
125
Prostatitis
95
Genitourinary
36
Renal
99
Cirrhosis
50
55
68
31
91
49
70
27
5
8
1
14
16
Category
Normal Males
≤40 years
>40 years
Malignant Disease*
Prostate
Stage A
30
Stage B
80
43
37
39
33
34
19
12
28
20
21
6
Stage C
Stage D
Genitourinary
*
•
•
Both treated and untreated patients.
99.2% of the VITROS PSA test concentrations in a study of 367 samples from normal males were found to be 4 ng/mL or
less.
Of 182 samples from patients with prostatic cancer, 94 samples had VITROS PSA test concentrations above 4 ng/mL.
Interpretation of Results
For patient sample values outside your established reference interval, the system may be configured to display a flag ‘Hi’.
Refer to the operating instructions for your system.
Version 6.0
7
PSA
Performance Characteristics
Limit of Detection
The Limit of Detection (LoD) for VITROS PSA is 0.064 ng/mL, determined consistent with NCCLS document EP1723 and with
proportions of false positives (α) less than 1% and false negatives (β) less than 1%; based on 699 determinations, with 1 blank
and 5 low-level samples. The Limit of Blank (LoB) is 0.036 ng/mL.
For the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, the LoB and LoD were verified
consistent with NCCLS document EP17.23 The data presented are a representation of the product performance.
Limit of Blank and Limit of Detection
LoB*
ng/mL
0.036
LoD**
ng/mL
0.064
* Limit of Blank, or the highest value likely to be observed with a sample
containing no analyte, replaces the term "analytical sensitivity."
** Proportions of false positives (α) and false negatives (β) were less than
1%; based on 699 determinations, with 1 blank and 5 low-level samples.
Functional Sensitivity
Using a human serum matrix, functional sensitivity of this test is 0.1 ng/mL. Functional sensitivity is defined as the
concentration which corresponds to the 20% between-test coefficient of variation from the precision dose profile.24 The
functional sensitivity of this test was calculated across a single 28 day calibration interval.
The functional sensitivity of this test was verified on the VITROS 3600 Immunodiagnostic System and the VITROS 5600
Integrated System across 5 days, using a human serum matrix.
Accuracy (Method Comparison)
Accuracy was evaluated consistent with NCCLS document EP9.25 The plot and table show the results of a method comparison
study using patient samples from a variety of clinical categories analyzed on the VITROS ECi/ECiQ Immunodiagnostic System
compared with those analyzed using the Hybritech Tandem-R PSA test. The relationship between the 2 methods was
determined by Passing and Bablok regression.26
The table also shows the results of method comparison studies27 using patient serum and plasma samples analyzed on the
VITROS ECi/ECiQ Immunodiagnostic System compared with those analyzed using the VITROS 3600 Immunodiagnostic
System and the VITROS 5600 Integrated System. The relationship between the 2 methods was determined by Passing and
Bablok regression.26
VITROS ECi/ECiQ (ng/mL)
Conventional Units
Comparative Method: Hybritech Tandem-R PSA test (ng/mL)
8
Version 6.0
PSA
Performance Characteristics
Conventional Units (ng/mL)
System
n
Correlation
Slope Coefficient
Range of
Samples
Intercept
ECi/ECiQ vs.
Comparative Method
201 1.028
0.989
0.000–97.2
-0.089
3600 vs. ECi/ECiQ
107 0.938
0.998
0.607–89.1
-0.067
5600 vs. ECi/ECiQ
107 0.937
0.997
0.607–89.1
-0.067
Precision
VITROS ECi/ECiQ Immunodiagnostic System
Precision was evaluated consistent with NCCLS document EP5.28 Two replicates each of 3 control samples were tested on 2
separate occasions per day on at least 20 different days. The experiment was performed using 2 reagent lots on 2 different
systems. The data presented are a representation of the product performance.
VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System
Precision was evaluated consistent with NCCLS document EP5.29 Two replicates of each of 3 freeze dried control samples
were tested on 2 separate occasions per day on at least 20 different days. The experiment was performed using 1 reagent lot
on each system. The data presented are a representation of the product performance.
Units = ng/mL
System
ECi/ECiQ
system 1
ECi/ECiQ
system 2
3600
5600
Mean PSA
Conc.
0.446
4.23
50.7
0.489
4.28
52.4
2.13
15.5
50.6
2.10
15.3
49.6
Within-run*
SD
0.007
0.046
0.904
0.010
0.047
0.905
0.021
0.225
0.779
0.030
0.275
0.749
CV (%)
1.6
1.1
1.8
2.0
1.1
1.7
1.0
1.4
1.5
1.4
1.8
1.5
Within-calibration**
SD
0.023
0.195
2.03
0.027
0.150
2.13
0.051
0.443
1.53
0.050
0.421
1.41
CV (%)
5.2
4.6
4.0
5.5
3.5
4.1
2.4
2.9
3.0
2.4
2.8
2.8
Within-lab***
SD
0.032
0.178
1.87
0.036
0.188
1.83
0.039
0.327
1.11
0.047
0.351
1.22
CV (%)
7.2
4.2
3.7
7.4
4.4
3.5
1.8
2.1
2.2
2.2
2.3
2.5
No.
Observ.
80
80
80
80
80
80
96
96
96
92
92
92
No.
Days
20
20
20
20
20
20
24
24
24
23
23
23
*
Within-run (repeatability). Between Duplicate precision averaged over all runs
** Within-calibration. Total precision with weighted components of within-run, between–run and between-day variation
*** Within-lab. A measure of the effect of recalibration on total precision, calculated within reagent lot, using data from at least 4
calibrations
Version 6.0
9
PSA
Specificity
Substances that do not Interfere
The VITROS PSA test was evaluated for interference consistent with CLSI document EP7.16 Of the compounds tested, none
was found to cause a bias of >5% with the test at PSA concentrations of 3.10–5.33 ng/mL.
Compound
Acetylsalicylic acid
Ascorbic acid
Bilirubin
Biotin
Cyclophosphamide
Diethylstilbestrol
Doxorubicin hydrochloride
Estramustine phosphate
Flutamide
Goserelin acetate
Hemoglobin
Ibuprofen
Lupron
Megestrol acetate
Methotrexate
Triolein
10
Compound Concentration
2.77 mmol/L
341 µmol/L
342 µmol/L
40.9 nmol/L
2.68 mmol/L
7.45 µmol/L
27.7 µmol/L
0.386 mmol/L
36.2 µmol/L
75 nmol/L
0.62 mmol/L
3.39 mmol/L
79.7 µmol/L
62.4 µmol/L
66.0 µmol/L
22.6 mmol/L
50 mg/dL
6 mg/dL
20 mg/dL
1 µg/dL
70 mg/dL
200 µg/dL
1.6 mg/dL
20 mg/dL
1 mg/dL
10 µg/dL
1000 mg/dL
70 mg/dL
10 mg/dL
2.4 mg/dL
3 mg/dL
2000 mg/dL
Version 6.0
PSA
References
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
Version 6.0
CA-A Cancer J Clin. 1998 figures at www.ca-journal.org/figures_1998.
Wang MC, Valenzuela LA, Murphy GP and Chu TM. Purification of a human prostate specific antigen. Invest Urol. 17:159–163; 1979.
Wang MC, Papsidero LD, Kuriyama M et al. Prostate antigen: a new potential marker for prostatic cancer. The Prostate. 2:89–96; 1981.
Papsidero LD, Wang MC, Valenzuela LA et al. A Prostate Antigen in Sera of Prostatic Cancer Patients. Cancer Res. 40:2428–2432; 1980.
Oesterling JE. Prostate specific antigen: a critical assessment of the most useful tumor marker for adenocarcinoma of the prostate. J Urol.
145:907–923; 1991.
Stamey TA, Kabalin JN, McNeal JE et al. Prostate specific antigen in the diagnosis and treatment of adenocarcinoma of the prostate. II. Radical
prostatectomy treated patients. J Urol. 141:1076–1083; 1989.
Chybowski FM, Larson Keller JJ, Bergstralh EJ and Oestrling JE. Predicting radionuclide bone scan findings in patients with newly diagnosed,
untreated prostate cancer: prostate specific antigen is superior to all other clinical parameters. J Urol. 145:313–318; 1991.
Stamey TA, Kabalin JN, Ferrari M. Prostate specific antigen in the diagnosis and treatment of adenocarcinoma of the prostate. III. Radiation
treated patients. J Urol. 141:1084–1087; 1989.
Stamey TA, Kabalin JN, Ferrari M, Yang N. Prostate specific antigen in the diagnosis and treatment of adenocarcinoma of the prostate. IV. Antiandrogen treated patients. J Urol. 141:1088–1090; 1989.
Summers M et al. Luminogenic Reagent Using 3-Chloro 4-Hydroxy Acetanilide to Enhance Peroxidase/Luminol Chemiluminescence. Clin Chem.
41:S73; 1995.
CLSI. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - Third Edition. CLSI document M29-A3
(ISBN 1-56238-567-4). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005.
Calam RR. Specimen Processing Separator Gels: An Update. J Clin Immunoassay. 11:86–90; 1988.
CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Sixth Edition. CLSI document H3-A6
(ISBN 1-56238-650-6). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2007.
NCCLS. Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard – Fifth Edition. NCCLS
document H4-A5 [ISBN 1-56238-538-0]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA, 2004.
CLSI. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline - Third Edition. CLSI document
C24-A3 [ISBN 1-56238-613-1]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA, 2006.
NCCLS. Interference Testing in Clinical Chemistry; Proposed Guideline. NCCLS document EP7-P (ISBN 1-56238-020-6). NCCLS, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 1986.
Levinson SS. The Nature of Heterophilic Antibodies and Their Role in Immunoassay Interference. J Clin Immunoassay. 15:108–115; 1992.
Scientific Committee on Food. Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Biotin. European Commission,
SCF/CS/NUT/UPPLEV/55 Final, Brussels, 2001.
Bonfrer JMG. Working Group on Tumor Marker Criteria (WGTMC). Tumor Biol. 11:287–288; 1990.
Young DS. Effects of Drugs on Clinical Laboratory Tests ed. 4. Washington, D.C.: AACC Press; 1995.
Friedman RB, Young DS. Effects of Disease on Clinical Laboratory Tests. ed. 3. Washington, D.C.: AACC Press; 1997.
Tryding N, Tufvesson C, Sonntag O (eds). Drug Effects in Clinical Chemistry. ed. 7. Stockholm: The National Corporation of Swedish Pharmacies,
Pharmasoft AB, Swedish Society for Clinical Chemistry; 1996.
NCCLS. Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. NCCLS document EP17-A (ISBN
1-56238-551-8). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 2004.
Spencer CA et al. Interlaboratory/Intermethod Differences in Functional Sensitivity of Immunometric Assays of Thyrotropin (TSH) and Impact of
Reliability of Measurement of Subnormal Concentrations of TSH. Clin Chem 41: 367–374, 1995.
NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS document EP9-A (ISBN 1-56238-283-7).
NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 1995.
Passing H, Bablok W. A New Biometrical Procedure of testing the Equality of Measurements from Two Different Analytical Methods. J. Clin
Chem Biochem. 21: 709-720, 1983
NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition. NCCLS document EP9-A2
(ISBN 1-56238-472-4). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2002.
NCCLS. Evaluation of Precision Performance of Clinical Chemistry Devices – Second Edition; Tentative Guideline. NCCLS document EP5-T2
(ISBN 1-56238-145-8). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 1992.
NCCLS. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition. NCCLS document
EP5-A2 [ISBN 1-56238-542-9]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA, 2004.
11
PSA
Glossary of Symbols
12
Version 6.0
PSA
Revision History
Revision History
Date of
Revision
2011-05-18
Version
6.0
2009-08-18
5.0
2009-03-12
4.0
2005-03-17
1.0 (GEMC115)
2005-03-11
3.0 (J03792)
2002AUG21
2.0 (J03792)
2002FEB28
1.0 (J03792)
*
Version 6.0
Description of Technical Changes*
Removed Oncology Controls:
• Materials Required but not Provided
• Quality Control Material Selection
• Reagent Pack Storage and Preparation - ECi/ECiQ (Lot 2590 and above):
changed open stability to 8 weeks
• Quality Control Procedure Recommendations: updated
• Limit of Detection: updated
• New format that combines the following into one document:
− PSA Reagent Pack (J03792_EN_US), version 3.0
− PSA Calibrator (GEMC115_EN_WW), version 1.0
• Added information for the VITROS 3600 Immunodiagnostic System and the
VITROS 5600 Integrated System.
• Updated risk and safety statements
• Reagent Pack Storage and Preparation: changed open stability to 4 weeks
• Measuring (Reportable) Range: added lower limit based on limit of
detection for the VITROS Immunodiagnostic and VITROS Integrated
Systems
• Other Limitations: added biotin statement
• Limit of Detection: added new section
• Analytical Sensitivity: removed section
• References: updated
• Glossary of Symbols: updated
New format, technically equivalent to PIGEMC115/101.0 with the following
minor changes:
• Replaced Symbols used with Glossary of Symbols table
• Added Revision History, signature box
• Changed all occurrences of “VITROS Immunodiagnostic System”, “VITROS
ECi System” and “VITROS ECi Immunodiagnostic System” to VITROS
ECi/ECiQ Immunodiagnostic System.
• Warnings and Precautions: updated wording and added contains
2-Chloroacetamide warning statement to align with new format.
• Reagent Pack Contents: removed footnote reference to lot number specific
volumes for reagents.
• Limitations of the Procedure: Other Limitations – added -Hemogloblin may
interfere with the VITROS PSA assay. At a PSA level of ≤0.03 ng/mL,
hemoglobin at 200; 400 and 600 mg/dL caused a positive bias of 0.118;
0.270 and 0.390 ng/mL, respectively.
• Glossary of Symbols table: added table.
• References: updated reference 11
• Copyright box: updated copyright box.
Reagent Pack Content:
• revised CAT. No.
• revised reagent fill volumes
New format.
Update to 2001OCT17 – Back page, trademark.
The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.
13
PSA
When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory
policies, as appropriate.
_________________________________
Signature
_____________
Obsolete Date
Conditions of supply: all supplies are made subject to the standard terms and conditions of Ortho-Clinical Diagnostics or its distributors.
Copies of these are available on request.
Supplied by:
Fujirebio Diagnostics, Inc.
Malvern, PA, USA
Distributed in the US by:
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, NY 14626
Ortho-Clinical Diagnostics
Johnson & Johnson
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4DP
United Kingdom
VITROS is a trademark of Ortho-Clinical Diagnostics, Inc.
© Ortho-Clinical Diagnostics, Inc., 2002-2011.
14
Version 6.0

PSA INSTRUCTIONS FOR USE

Transcription

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