High Accuracy AFP Tumor Maker POCT FIA Rapid Test Kit By NIR-1000 Dry Fluoroimmunoassay Analyser.

【Product name】 AFP.pdf

Alpha Fetoprotein (AFP) Rapid Quantitative Test (Fluorescence immunoassay)

【Intended use】

This kit is used for quantitative determination of AFP in human whole blood, plasma and serum.

Alpha fetoprotein(AFP), the foetal aquivalent to albumin, is a 67kDa glycoprotein produced during embryonic development and found in high concentration in fortal serum and amniotic fluid. In normal non-pregnant adults AFP is present in low concentrations in serum. However AFP may markedly increased in the serum from patients with cancer of the liver, testis or ovary. Quantitative determination of AFP serum may be valuable in the management of patients with suspected or diagnosed liver cancer or germ cell tumors of the testis or ovary.In addition, elevated serum AFP concentration have been measured in patients with other noncancerous,diseases,including ataxia telangiectasia hereditary tyrosinemia neonatal hyperbilirubinemia acuter viral hepatitis, chronic active hepatitis and cirrhosis. Elevated serum AFP concentration are also observed in pregnant woman. Therefore AFP measurement are not recommended for use as a screening procedure to detect the presence of cancer in the general population.

【Inspection principle】

The AFP Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of AFP. The AFP antigen in the sample was first bound with the conjugated compound of fluorescent labeled AFP monoclonal antibody, then moved and combined with another AFP 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.

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】

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 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.)
3. Remove the test card from the aluminum foil bag and use it within 15 minutes.
4. Place the test card on a clean horizontal table and mark it horizontally.
5. Mix 100 µL of patient sample with 300µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.
6. 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.

【Reference interval】

Healthy non-pregnant adults are expected to have serum AFP values below 20ng/ml. It is strongly recommended that each laboratory should determine its own normal and abnormal values based on population.

【Interpretation of results】

1. This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.
2. For samples with AFP concentration lower than 2.5ng/ml and higher than 200ng/ml, the detection results are reported as "< 2.5ng/ml" and "> 200ng /ml", respectively.               

 


WWHS Assay List