One-step pregnancy Test is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy. The test device is intended for self-testing.
The One-step HCG pregnancy Test is a rapid qualitative one step assay for the detection of HCG in urine. The method employs a unique combination of monoclonal dye conjugate and polyclonal-solid phase antibodies to selectively identify the HCG in the test samples with an extremely high degree of sensitivity. In less than 5 minutes levels of HCG as low as 25mlU/ml can be detected.
As the test sample flows through the absorbent device the labeled antibody-dye conjugate binds to the HCG forming an antibody-antigen complex. This complex binds to the anti-HCG antibody in the positive reaction zone (“T” area) and produces a pink-purple colored band when the HCG concentration is greater than 25mlIU/ml. In the absence of HCG there is no line in the positive reaction zone. Unbound conjugate binds to the reagents in the control zone (“C” area) producing a pink-purple band demonstrating that the reagents are functioning properly.
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