The Biorex Diagnostics hCG One Step Pregnancy Test Device (Urine/Serum) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy.

Human chorionic gonadotropin is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both urine and serum as early as 7 to 10 days after conception. hCG levels continue to rise very rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period, and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy. The appearance of hCG in both urine and serum soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy.