【INTENDED USE】

The hCG Rapid Test Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy.

【SUMMARY】

Human chorionic gonadotropin (hCG) 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.(1-4) hCG levels continue to rise very rapidly, frequently exceeding 100mIU/mL by the first missed menstrual period,(2-4) and peaking in the 100,000-200,000mIU/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.

The hCG Rapid Test Strip is a rapid test that qualitatively detects the presence of hCG in serum or urine specimen at the sensitivity of 25mIU/mL.The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in serum or urine.At the level of claimed sensitivity, the hCG Rapid Test Strip shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH,hLH and hTSH at high physiological levels.