【Product name】 CysC.pdf
Carcinoembryonic Antigen (CEA) Rapid Quantitative Test(Fluorescence
immunoassay)
【Intended use】
This kit is used for quantitative determination of CEA in human
whole blood, plasma and serum.
Carcinoembryonic antigen (CEA) is a tumor associated antigen, first
described in 1965 by Gold and Freedman1. It is a cell-surface
glycoprotein with a molecular weight of 180-200kD, that occurs in
high levels in colon epithelial cells during embryonic development.
Levels of CEA are significantly lower in colon tissue of adults,
but can become elevated when inflammation or tumours arise in any
endodermal tissue, including the gastrointestinal tract,
respiratory tract, pancreas and breast.
An over expression of CEA protein has been detected in a variety of
adenocarcinomas, including gastric, pancreatic, small intestine,
colon, rectal, ovarian, breast, cervical and non-small-cell lung
cancers. CEA is also expressed by epithelial cells in several
non-malignant disorders, including diverticulitis, pancreatitis,
inflammatory bowel disease, cirrhosis, hepatitis, bronchitis and
renal failure and also in heavy smokers.
Therefore CEA should not be regarded as a tumour-specific marker
for the screening of a general population for undetected cancers.
However, the determination of CEA levels provides important
information about patient prognosis, recurrence of tumours after
surgical removal and effectiveness of therapy.
【Components】
| Name | Quantity | Component |
| Test cards | 25 | It is composed of fluorescent pad (coated with fluorescent labeled
CEA monoclonal mouse antibody), nitrocellulose membrane (coated
with CEA monoclonal mouse antibody and Goat anti mouse IgG
antibody), absorbent paper and backing |
| Sample diluent | 25(300μL/tube) | Phosphate buffer |
| ID card | 1 | With specific stand curve file |
The components in different batches of kits cannot be used
interchangeably.
【Storage conditions and validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is
valid for 18 months. The test card should be used within 15 minutes
after unsealing under the environment of 15℃~30℃ and 20% ~ 90%
relative humidity.
The production date, batch number and expiration date are shown in
the outer package of the product.
【Applicable instruments】
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech.
Inc.
【Procedure】
- Before the test, please read the instructions completely. If the
test card and sample are stored in cold storage, they should be
balanced at room temperature (15-30)℃ for not less than 30min
before use.
- Start NIR-1000 dry fluoroimmunoassay analyser according to the
instruction manual of the instrument, and carry out quality control
verification according to the instruction manual of the
instrument(Note: the reagent has been calibrated in advance, and
the calibration curve parameters of each batch of reagent have been
stored in the information card. The information card is inserted
before use, so it is not necessary to calibrate again, and the test
can be carried out only after the quality control is passed.
Otherwise, the cause should be found out before testing.)
- Remove the test card from the aluminum foil bag and use it within
15 minutes.
- Place the test card on a clean horizontal table and mark it
horizontally.
- Mix 100µL of patient sample with 300µL of sample diluent. Apply
100µL of diluted samples to the well of the test card.
- Insert the test card into NIR-1000 dry fluoroimmunoassay analyser,
read and record the results at 10 minutes after addition of
samples, then dispose of used test appropriately.
【Limitations of methods】
- This kit is only used to detect human plasma/whole blood samples
- Due to the limitations of immunoassay methods of antigen and
antibody reaction, the results cannot be used as the only basis for
clinical diagnosis, but should be evaluated with all the existing
clinical and experimental data.
- The content of triglyceride in the sample shall not exceed 15mg/ml,
the content of hemoglobin shall not exceed 5mg/ml, and the content
of bilirubin shall not exceed 0.5mg/ml, and the relative deviation
of the test results shall not exceed ±15%.
- When the concentration of CEA in the sample is less than
20000ng/ml, there is no hook effect.
- HAMA effect was not produced when the concentration of human anti
rat in the sample was less than 50ng/ml.
- When RF concentration in the sample is less than 2000IU/ml, the
relative deviation of the test results is within ±15%.
【Performance】
1. Limits of detection
No more than 1ng /ml.
2. Accuracy
The relative deviation from the target value is within ±15%.
3. Precision
The within and between assay coefficient of variations are within
15%.
4. Linear range
Within the linear range (1 ~ 500ng/ml), the linear correlation
coefficient R≥0.990.
