Place of Origin:
CN
Brand Name:
WWHS
Certification:
ISO13485, CE
Model Number:
CEA
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【Product name】 CEA.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.
【Remark】
1, Room temperature store and transport, shelf life 12 months.
2,After dissolved, should store at -20℃, shelf life 1 month.
3,Each unit for 10 tests.
【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.
【Sample requirements】
【Reference interval】
Normal persons who do not smoke: 95% had values less than 5ng/ml. The normal reference value is 5ng/ml in this assay. It is recommended that each laboratory should establish its own normal range based on a representative sampling of the local population.
【Interpretation of results】
【Limitations of methods】
【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.
【Note】
1. This kit is only used for in vitro diagnosis.
2. The test card and sample diluent are disposable and cannot be reused.
3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃ ~ 30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.
4. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.
5. The used kits should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.
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