REF:

C1103 (Strip)

C1104 (Cassette)

C1105 (Midstream Stick)

INTENDED PURPOSE:

NOVAtest® One Step hCG Urine Test offers a rapid, visually read and qualitative test for fertile women. The user can know if she is pregnant by testing her urine sample with this double-antibody sandwich method of lateral flow immunoassay. This test is entirely manual by the user.

INTENDED USER:

Performance of the test is limited to self-testing at home. The test can be applied to any fertile woman.

SUMMARY:

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the syncytial cells of the placenta during pregnancy and is a marker for early detection of pregnancy. In normal pregnancy, hCG can be detected in urine sample as early as 7 to 10 days after conception. The main symptom of early pregnancy includes: the absence of menstruation, breast tingling, swelling, itching, nausea and vomiting, etc. The level of hCG continues to rise very rapidly. The further into the pregnancy, the higher the concentration of hCG in the urine. The concentration of hCG in non-pregnant women is normally lower than 5.0mIU/mL. At the time of the first missed menstrual period, the hCG level frequently exceeds 20mIU/mL, and peaks at 100,000mIU/mL around weeks 10-12.

The main methods of detecting pregnancy are ultrasound testing and blood or urine hCG testing. Urine hCG test is simple to operate and can quickly detect pregnancy within 10 minutes with high sensitivity and specificity.