Place of Origin:
FOB and TRF
【Product name】 FOB.pdf
Fecal occult blood (FOB) Rapid Test(Fluorescence immunoassay)
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.
The CEA Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of CEA. The CEA antigen in the sample was first bound with the conjugated compound of fluorescent labeled CEA monoclonal antibody, then moved and combined with another CEA monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.
【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.
Nir-1000 dry fluorescent immunoassay analyzer produced by WWHS Biotech. Inc.
Normal persons who do not smoke: 95% had values less than 5 ng/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.
【Limitations of methods】
1. Limits of detection
No more than 1ng /ml.
The relative deviation from the target value is within ±15%.
The within and between assay coefficient of variations are within 15%.
4. Linear range
Within the linear range (1 ~ 200ng/ml), the linear correlation coefficient R≥0.990.
|cat#.||Product item||Specimen||Reaction Time||Measure Range||Clinical Range||Itended Use|
|36||FOB||fecal specimens||10min.||qualitative||qualitative||gastrointestinal hemorrhage.|
|37||TRF||fecal specimens||10min.||qualitative||qualitative||gastrointestinal hemorrhage.|
|38||FOB+TRF||fecal specimens||10min.||qualitative||qualitative||gastrointestinal hemorrhage.|
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