INTENDED USE
New Choice-Pro hCG Pregnancy Test 2000 mIU/mL is a rapid chromatrographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the diagnosis of pregnancy. It is intended for professional central laboratory use only. For in vitro diagnostic use only.
SUMMARY AND EXPLAINATION
hCG is a glycoprotein hormone produced by the developing placenta shortly after fertilization. After conception. hCG levels continues to rise very rapidly, frequently exceeding 100mIU/mL by the first missed menstrual period, and peaking in the 50,000 mIU/mL range about 8-11 weeks into pregnancy. The appearance of hCG in urine soon after conception, and its subsequent rapid rise in concentration, make it an excellent marker for confirming pregnancy. 7,10
New Choice-Pro hCG Pregnancy Test 2000 mIU/mL is a rapid test that qualitatively detects the presence of hCG in urine specimen at the sensitivity of 2000mIU/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, New Choice-Pro hCG Pregnancy Test 2000 mIU/mL shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.
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