The First Sign® One-Step Urine Pregnancy Test is rapid qualitative one step assay for the detection of hCG in urine. The method employs a unique combination of monoclonal dye conjugate and polyclonal-solid phase antibodies to selectively identify the hCG in the test samples with an extremely high degree of sensitivity. As early as 5 minutes, level of hCG as low as 25mIU/mL can be detected.
As the test sample flows through the absorbent device, the labeled antibody-dye conjugate binds to the hCG forming an antibodyantigen complex. This complex binds to anti-hCG antibody in the positive reaction zone ("T" area) and produces a pink-purple colored band when the hCG concentration is greater than 25mIU/mL. In the absence of hCG, there is no line in the positive reaction zone. Unbound conjugate binds to the reagents in the control zone ("C" area), producing a pink-purple band, demonstrating the reagents are functioning properly.
- FDA 510K Cleared and CLIA Waived
- Easy to use
- Result at 5 minutes
- Clear & accurate result
- Built-in quality control
- Urine or combo cassettes
- Urine strip
