Pregnancy test midstream is a tool used by women to detect whether they are pregnant. The principle of the test is to detect human chorionic gonadotropin (Human Chorionic Gonadotropin, referred to as HCG) in human urine. If two lines are displayed on the pregnancy test stick, it is pregnant (positive).HCG is a gonadotropin secreted by the placenta of pregnant women. It is distributed throughout the body with the blood and acts on target organs. There is also a certain concentration of HCG in the urine. The vast majority of pregnancy test products on the market use the collidal gold method to detect HCG in urine qualitatively or semi-quantitatively according to the double-antibody sandwich principle to determine whether you are pregnant. It is worth noting that such pregnancy test products are not 100% accurate, and certain diseases may also increase the concentration of HCG in the body, resulting in false positive results.

Product principle:

Pregnancy Test Kit adopts highly specific antigen-antibody reaction and colloidal gold immune chromatography to detect HCG. In a specific wavelength, the amount of colloidal gold particles is associated with the absorption and scattering to light. By using the photoelectric sensor to detect the absorption and scattering of colloidal gold particles to the light, the amount of antigen to be determined can be obtained.

Indicators of product technical characteristics:

1)Meeting the “Pregnancy Test Kit registered product standard” requirement.

2)The accordance rate of negative reference material: the concentration should be fully detected as 0 mIU/ml after the determination of 20 negative serum samples.

3)Accuracy: the HCG serum with the specified value is used for the determination. Each of the concentration is taken its mean for five times and the mean deviation of its respective concentration is not more than 10%.

4)Linear correlation coefficient: r≥0.99

5)Minimum detectable amount: the concentration is not higher than 25mIU/ml.

6)Sensitivity: the measured concentration of reagent whiteboard is 0 mIU/ml.

7)Precision: the repeatable requirement of intra-and inter-regent is not more than 10%.