[INTENDED USE]
The HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for
qualitative detection of human chorionic gonado (HCG) in urine. The test
midstream can accurately detect pregnancy when the level of HCG is between
25mIU/ml to 500,000mIU/ml.
[PRINCIPLE]
Because the amount of a hormone called human chorionic gonado (HCG) in the
body increases rapidly during the first two weeks of pregnancy, the test midstream
will detect the presence of this hormone in urine as early as the first day of a missed
period.
The test reagent is exposed to urine, allowing urine to migrate through the absorbent
test midstream. The labeled antibody-dye conjugate binds to the HCG in the
specimen forming an antibody-antigen complex. This complex binds to the anti-HCG
antibody in the test region (T) and produces a red line when HCG concentration is
equal to or greater than 25mIU/ml. In the absence of HCG, there is no line in the test
region (T). The reaction mixture continues flowing through the absorbent device past
the test region (T) and control region (C). Unbound conjugate binds to the reagents in
the control region (C), producing a red line, demonstrating that the test midstream is
functioning correctly.