【Product name】 30. bHCG.pdf

β- Human Chorionic Gonadotropin(β-HCG)Rapid Quantitative Test(Fluorescence immunoassay)

【Package specification】

25 Tests/kit

【Intended use】

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

Human chorionic gonadotropin (HCG) is a glycoprotein secreted by trophoblast cells of the placenta, which is produced by α and β The glycoprotein composition of dimer. The molecular weight of glycoprotein hormone is 36700, The α subunits are similar to FSH, LH and β-HCG secreted by pituitary gland, so they can cross react with each other, but not with β subunits. After the fertilized eggs move to the uterine cavity for implantation, mature women form embryos. In the process of growing into fetus, placental syncytiotrophoblast cells produce a large amount of HCG, which can be excreted into the urine through the blood circulation of pregnant women. The HCG levels in serum and urine increased rapidly at 1-2.5 weeks of gestation, peaked at the 8^th week of gestation, and then decreased to the medium level at the 4^th month of gestation, and maintained until the end of pregnancy.

【Inspection principle】

The β-HCG Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of β-HCG. The β-HCG antigen in the sample was first bound with the conjugated compound of fluorescent labeled Β-HCG monoclonal antibody, then moved and combined with another β-HCG 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 20 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】

The normal reference value is 5mIU/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. This kit is only used to detect human plasma/whole blood samples
2. 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.
3. 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%.
4. When the concentration of β-HCG in the sample is less than 200000mIU/mL, there is no hook effect.
5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.
6. 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 2mIU/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 (2 ~ 100000mIU/mL), the linear correlation coefficient R≥0.990.