HCG pregnancy test strip 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.

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%.