One Step HCG pregnancy diagnostic test CE approval

Product Description

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 *0 days after conception. hCG levels continue to rise very rapidly, frequently exceeding **0 mIU/mL by the first missed menstrual period, and peaking in the **0,******0,**0 mIU/mL range about ****2 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 One Step hCG Single Test Kit is a rapid test that qualitatively detects the presence of hCG in urine specimen at the sensitivity of *5 mIU/mL. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine. At the level of claimed sensitivity, the One Step hCG Single Test Kit shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.