FOB And TRF Rapid Test Kit Is A Tumor Associated Antigen 25T CE Approval WWHS FIA POCT Assay

【Product name】 FOB.pdf

Fecal occult blood (FOB) Rapid 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.

【Test procedure】

1. 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.

2. Start NIR-1000 dry fluoroimmunoassay analyzer and correctly select the corresponding sample type on the instrument.

3. Take out the ID card, make sure that the batch number of the ID card is consistent with that of the test card, and insert the ID card into the ID card port of the instrument.

4. Unscrew the fecal collection tube, use the fecal collection rod to take feces, place the fecal collection rod in the tube, screw the tube cover, shake the tube up and down for several times, and fully mix the sample.

5. Take out the test card from the aluminum foil bag and use it within 15 minutes.

6. Place the test card on a clean horizontal table and mark it horizontally.

7. Apply 100 µL (or 3 drops) of diluted samples to the well of the test card.

8. Insert the test card into NIR-1000 dry fluoroimmunoassay analyzer and click the “instant test” button to read the results at 10 minutes after addition of samples.

【Reference interval】

The minimum detection limit of hemoglobin is not higher than 0.20 µg/mL.

The minimum detection limit of transferrin is not higher than 0.04μg/mL.

【Performance】

1. Limits of detection

Hb: No higher than 0.2 µg/mL; TRF: No higher than 0.04 µg/mL

2. Coincidence rate

10 pcs of positive quality control are been tested, the positive coincidence rate of Hb and TRF is not less than 90%. 10 pcs of negative quality control are been tested, the negative coincidence of Hb and TRF rate is not less than 90%.

3. Repeatability

Test positive quality control and negative quality control 10 times in parallel, the result of Hb and TRF were basically the same, with a repetition rate of ≥90.0%, and the coefficient of variations of Hb and TRF are within 15.0%.

4. Batch-to-batch variation

3 batches of cassettes are randomly selected, 10 cassettes in each batch. Test positive quality control, the coefficient of variations of Hb and TRF are within 15.0%.

Other WWHS Assay Items