REF:

C1101 (Strip)

C1102 (Cassette)

INTENDED PURPOSE:

NOVAtest® One Step hCG Combo Test is an immunoassay that uses double-antibody sandwich method for qualitative detection of human chorionic gonadotropin (hCG) in human serum and urine specimens. It’s used for aid to diagnosis pregnancy. This device is performed manually.

INTENDED USER:

Performance of the test is limited to laboratory professional use.

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 both urine and serum samples 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 both in urine and serum. The concentration of hCG in non-pregnant women is normally lower than 5.0 mIU/mL. At the time of the first missed menstrual period, the hCG level frequently exceeds 20 mIU/mL, and peaks at 100,000 mIU/mL around weeks 10-12.

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