Liquid-based Preparation System - DAAN Gene Co., Ltd. of Sun Yat

Liquid-based Preparation System
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CHINA
Daan Gene Co., Ltd. Of Sun Yat-Sen University
19 Xiangshan Road, Science Park, High & New Technology
Development District, Guangzhou, GuangDong, P. R. China, 510665
Tel: +86 20 32290789
Fax: +86 20 32068352
Marketing Email: marketing@daangene.com
Sales Email: orders@daangene.com
Website: http://en.daangene.com
CANADA
Daan Diagnostics Ltd.
#200- 5050 Kingsway, Burnaby, B.C., Canada, V5H 4H2
Tel: 604.451.7588
Fax: 604.451.7587
Email: orders@daangene.com
Website: http://www.daandiagnostics.com
Automatic LBP System
Liquid-based Cytology Settlement-Slide
Preparation and Dyeing System
Intended use
Liquid-based cytology settlement slide
processing and dyeing machine (hereinafter referred to as slide processing
and dyeing machine) removes interference components in sample through
a dedicated filter, produces and stains
cells in batches and produce thin layer
for pathological diagnosis, applicable
for cell pathological test.
Size: L 615mm*W 245mm*H 540mm
Weight:38kg
Inputting Power Supply: AC 220V (±10%), 50Hz
Advantages
Separation & Extraction Technique
Centrifugally separation the blood and mucus from specimens, and extract cells and diagnostic
components.
Gravity-driven Sedimentation Technique
Selectively capture injured cells.
The outstanding treatment of non-gynecological specimens as well.
The number of cells on the slide can be adjusted according to your diagnostic needs when preparation.
Automatic Batch Slide Preparation and Staining
Independently stain each slide to avoid cross-contamination.
Fully comply with the international standard of Pap Stain (wet stained slide).
Main Technical Parameters of the Staining Machine
Main Technical Parameters
1. Quantity of production dyeing samples in each batch
(1～12) pieces/batch
Less than 30 minutes/12 pieces
1. Quantity of slide staining samples in each batch
(1～24)pieces/batch
2. Average slide dyeing time
2. Average slide staining time
About 38 minutes/24 pieces
3. Buffer solution is added into each sample centrifugal tube
3. Buffer solution is added into each sample centrifugal tube
800～1,000μl, adjustable
4. Dosage of flushing fluid added into the staining compartment for each slide
preparation
5. Dosage of color solution added into the staining compartment for each slide
preparation
6. Dosage of color solution added into the staining compartment for each slide
preparation
500μl
7. Storage of the centrifuge tube with the sample
24
8. Storage of LBP special nozzle
24
9. Overall size of the staining machine
Length, width, height＝720mm×605mm×600mm
10. Weight of instrument
About 85kg
11. Power supply
12. Rated power
13. Power supply for computer monitoring
14. Fuse mode
15. GB 4793.1-1995 safety classification
1
(200~1000)µl, error±10%;
adjustment precision is not more than 1µl
(200~500)µl, error±10%;
adjustment precision is not more than 1µl
4. Cell transfer amount per sample
5. Added washing fluid quantity for each slide processing and dyeing chamber
500µl±10%
6. Added buffer solution amount for each slide processing and dyeing chamber
500µl±10%
7. Added dyeing solution amount for each slide processing and dyeing chamber
Hematoxylin solution 200µl±10%
8. Added dyeing solution amount for each slide processing and dyeing chamber
EA/OG liquid 200µl±10%
9. Storage of the centrifuge tube with the sample
12 pieces
10. Storage of DC special nozzle
14 pieces
11.Overall size of equipment
Length, width, height=640mm×412mm×680mm
AC 220VAC±10%, 50Hz±1Hz
12. Weight of instrument
Approximately 65kg
600W
Working voltage: 220V/AC:0.5AWorking
frequency: 50Hz
13. Power supply
AC 220V, 50Hz
14. Rated power
150VA
5A/250VAC.
Anti-electric shock Class I, overvoltage
of Class Ⅱ
15. Fuse mode
F5AL250V
Hematoxylin staining solution 500μl
EA/OG solution 500μl
2
The Comparison Between LBP and Pap Smear
Take lung cancer screening as example.
Specimen
treatment
Slide
preparation
and staining
Conventional Pap Smear
Cell
distribution
Clear slide background and diagnostic clues. Equal cell
distribution and flat thin-layer.
Unequal cell distribution with uneven together
into masses or pieces, which will interfere
diagnosis.
Cell
structure
The specific preservative solution can give good preservation
for the integrated structure of cell. Reasonable adjustment of
HP value can get endochylema, cytoplasm and nucleolus
stained to be clear, which helps to identify the benign &
malignant of cells and cellular components from different
sources.
Since the specimens are not fixed, there are
general epithelial cell degeneration, nucleus
swelling, splitting and disappearing after long
storage time for specimen collection. So the
morphological basis of cytological diagnosis
may be lost.
Staining
method
Independently modify Pap stain to avoid cross-contamination.
It will show the morphological characteristics of uroepithelium
cell ( transitional epithelial cell ) much better.
Wright-Giemsa stain or HE stain. The staining is
rather marked and bright, however, the staining
indistinct under the microscope. For nucleus is
darker and the chromatin is often indistinct under
the microscope.
Diagnosis
area/time
The slide is made with a diagnosis area of 13mm diameter
circle The average slide reading time is 3 minutes.
The diagnosis area is indefinite. Each slide
reading time is not average.
Collection
method
Special urine cups are used for collection. According to
different specimens, after adequate standing sedimentation,
take the urine at the bottom to make the slide with enriched
cells. The cell number from each slide is about 3000-5000.
Directly take a fraction of urine in bottle for
centrifugation, then smear and stain The cell
number from the slide is generally less.
Conventional Pap Smear
LBP
Specimen
preservation
LBP
1. The sputum is collected into the
specific specimen vial, which contains
20ml cell preservative solution
inactivating pathogens in sputum.
2. Fix the exfoliated cells of lung
tissue in sputum, which makes the
cells
be
not
deformed and
disintegrated, and preserve cell
histological type. It is beneficial to the
diagnosis for precancerous lesion
cells.
1. Sputum specimen is exposed to air without
preservative solution for fixing. It is easy
to spread pathogens,
2. The deformation and disintegration of cells
may affect diagnosis.
1. The whole process of mechanization
can avoid contacting with sputum. It is
healthy and safe. 100% exfoliated
cells of lung tissue in the sputum that
collected are used for slide preparation.
2. Remove mucus and other interference components in specimens,
make the cell slide with clear background. It is beneficial to the
pathologist's diagnosis.
1. Hand processing of sputum by doctors is
easy to be infected. Picking up a small part
from sputum to smear by experience and
discarding valuable cells may easily miss
diagnosis.
2. A lot of mucus and other interference
components and overlapping cells affect
the pathologist's diagnosis.
1. According to the principle of larger
proportion from injured cells, selectively capture injured cells.
2. Cells are limited to a diagnosis area
of 13mm diameter circle. Slide reading
time:2.5 minutes/slide.
1. Random smear, the selected probability for
the injured cells are rather Iow.
2. Unlimited scope, blurred visual field.
Slide reading time: >7 minutes / slide.
It is standardization and automation for slide preparation and
staining.
It standardizes each step of slide preparation and
Automation
staining process, reduces human error and improves work
efficiency.
Smear and stain by hand, which take much
more subjective with unstable preparation
quality.
Microscopic
cell
Workflow
Difference
under the
microscope
Detection
rate
Graphic representation:
lung adenocarcinoma cells, tissue cells and ciliated
columnar cells. Clear slide background and diagnostic clues.
Equal cell distribution and fiat thin-layer. Integrated structure
of cells, in which the distribution of nuclear
membrane,
nucleolus, nuclear chromatin granules are visible. And
the chromophilia of cytoplasm is normal, therefore, it can
help to identify cell types and sources.
Graphic representation:
the suspected squamous carcinoma cell. A lot
of mucus threads and inflammatory exudates
could be found from the conventional sputum
Pap smear. Cells are distributed unequally
and a single abnormal cell (in the middle of
visual field) is wrapped. Since specimens are
not fixed timely and the chromophilia of cell is
abnormal, the fine structure of cells was
vague. Therefore, it is a greater impact on
diagnosis and differential diagnosis.
The revolutionary reform takes place from specimen
collection to slide preparation. The detection rate gets
great improvement. Especially it is valuable for the
screening of recessive lung cancer
Low detection rate.
3
Specimen collection
Vortex
Observation result
Staining
Specimen extraction
Slide preparation
4
Specimen transfer
Software setting
The Comparison Between LBP and TCT on Preparation Process
The Comparison Between LBP and TCT Under Microscope
LBP
TCT
LBP
Specimen collection
The head of brush sampler
directly preserved in the
specimen vial, 100% cells
are used for preparation.
After
washing
brush
sampler, discard the
brush head, which will
cause the loss of at least
37% cells.
Specimen separation and extraction
No separation and extraction
Separate blood, mucus
and other interference
components in the
specimen by density
gradient reagent. Enrich
and extract cells and
diagnostic components
Directly filtrate cells with
membrane filter. The blood
and mucus in specimen will
block up membrane filter,
which causes insufficient
number of cells on the slide,
even blank slide. At the
same time, the mucus
adhered to the membrane,
which can be transferred to
the slide on preparation.
Slide preparation
Gravity-driven sedimentation of cells, which
well preserves cell morphology. The
karyoplasms ratio increases in injured cells,
whose proportion is larger than that of normal
cells and sedimentation velocity is faster. So
they are captured in priority by the slide that
has been coated with cell adhesive. The
quality of slide preparation is stable.
1-24 slide/batch
Staining
After rotating at high-speed mixing the specimens,
drawing specimen liquids with negative pressure and
passing through the filtering membrane, and attaching
the cells that collected by
membrane to the slide.
On slide preparation,
external force may
damage cell morphology.
Prepare specimens of
different density
(resistance) with
fixed negative pressure,
but the preparation
quality is uncontrollable .When the filtering
membrane can not be completely attached to the
slide, the cells that collected by the membrane will
be lost. The slide preparation quality is rather
unsatisfactory. It is a single slide preparation.
Histology
structure
.
Well-preserved
structure of
tissue fragments, which is closer
to its histological structure and
thus contributes to the differential
diagnosis of lesion and reactivity
changesdistribution and flat thinlayer.
External force will cause changes
in the structure of tissue fragments,
which leads to difficulties on
identifying malignant lesions and
benign reactive changes.
Cell
morphology
Integrated nuclear structure, in
which the distribution of nuclear
membrane, nucleolus, nuclear
chromatin granules are visible.
And
the
chromophilia
of
cytoplasm is normal, therefore,
it can help to identify cell types
and sources
Due to the external extrusion to
the cells when preparation, it
often leads to nuclear membrane
bursting, which results in difficulties
on diagnosis.
Recycling of the dye may change
the chromophilia of cell, which
leads to difficulties on identifying
cell types and sources.
Cell
distribution
5,000 to 120,000 different kinds
of cells are equally distributed in
the slide with a diagnosis area of
13mm diameter circle.
The covering area of squamous
epithelim is >40%. Columnar
epithelium/metaplastic epithelium
is 1-2 mass, 5-10 cells /mass.
The filtering membrane can not be
completely attached to the slide,
which results in unequal distribution
of cells. Cells often gather together
at the periphery, but it is blank in
the center.
Preserve the valuable diagnostic
background, which is clear and explicit.
There are mucus threads that are
difficult to be diluted in most of
smears. It causes the dirty and
disorderly background and lacks
of clear diagnosis background
Unsatisfactory rate is 0.06%. The advantage is more remarkable especially
in treating the specimens with blood.
More than 60-70% specimens
need to be centrifuged. Add mucus
diluting solution and glacial acetic
acid. Although specimens get
strict treatment, the unsatisfactory
rate is still more than 2%.
Since injured cells are captured at the greatest degree, its sensitivity is
greatly improved. Integrated cell structure, clear diagnostic clues and normal
chromophilia of cytoplasm, thus its specificity is also improved accordingly.
Since
impacts
from
several
important factors (such as specimen
collection, membrane blocking,
damage of cell structure), the
sensitivity and specificity decrease.
A diagnosis area of 13mm diameter circle. Through the certification by
American Pathology Quality Control Facility, the average slide reading time
is ≤2.5 minutes/slide.
A diagnosis area of 20 diameter
circle. Through the certification by
American
Pathology
Quality
Control Facility, the average slide
reading time is ≤4.5 minutes/slide.
Diagnostic
background
Unsatisfactory
rate of slide
preparation
Diagnostic
sensitivity
and
specificity
No staining
Independently stain each slide to avoid crosscontamination, which ensures the consistency
of slide preparation and staining.
No difference between batches. Fully comply
with the international standard of Pap Stain
(wet stained slide).
Ensure the chromophilia of cell structure, which
is more beneficial to the differential diagnosis.
5
TCT
Slide
reading
efficiency
Glossary
TCT—Thin-layer Cytology Test
LCT—Liquid-based Cytology Test
LBP—Liquid-based Preparation
6
.
Liquid-based Preparation Consumables Configuration List
(FNAB)
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11
3
12
4
13
5
14
7
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