One-Step Urine Pregnancy Cassette is a colloidal gold antibody complex based immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine. This test is for professional use in obtaining a visual qualitative result for the early detection of pregnancy.
As the test sample of urine diffuses through the absorbent reaction pack, the labeled antibody-dye conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hcG antibody in the test region (T) and produces a pinkrose color band when hCG concentration is equal to or greater than 25 mlU/ml. In the absence of hCG, there is no line in the test region. The reaction mixture continues flowing through the absorbent device past the test region and control region (C). Unbound conjugate binds to the reagents in the control region, producing a pink-rose color band, demonstrating that the reagents and reaction pack are functioning.