Check4® Pregnancy Urine hCG Test Strips

For Professional Use Only

Check4® Pregnancy is a rapid qualitative, one step assay for the detection of human chorionic gonadotropin in serum and urine For Professional Use Only. The method employs a unique combination of monoclonal-dye conjugate and polyclonal solid phase antibodies to selectively identify hCG in the test samples with a high degree of sensitivity. Levels as low as 25 mIU/ml in urine, and 10 mIU/ml in serum can be detected. As the test sample flows through the absorbent strip, the labelled antibody-dye conjugate binds to the hCG, forming an antibody-antigen complex. This complex binds to the anti-hCG antibody and produces a pink band in the positive reaction zone (see diagram) when the hCG concentration is greater than or equal to 25 mIU/ml (urine) or 10 mIU/ml (serum).

In the absence of hCG, there is no band in the positive reaction zone. The reaction mixture continues flowing through the absorbent strip past the positive reaction zone and control zone. Unbound conjugate binds to the reagents in the control zone producing a pink band, demonstrating that the reagents are functioning correctly. A single band therefore indicates a negative result, and a double band indicates a positive result.