Intended Use HCG Pregnancy Test is a self-testing immunoassay made for the rapid, visual and qualitative determination of human chorionic gonadotropin(HCG) in urine specimen to aid in the early detection of pregnancy. Summary Human chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by the developing placenta shortly after fertilization. In normal pregnancy, HCG can be detected in serum as early as 7 days following conception. The concentration of HCG continues to rise rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period and peaking in the 100,000-200,000 mIU/mL range by 10-12 weeks into pregnancy. The appearance of HCG soon after conception and its subsequent rise in concentration during early gestational growth make it an excellent marker for the early detection of pregnancy.