NAMADA-DxTM Pregnancy Tests
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both urine and serum as early as 7 to 10 days after conception. hCG levels continue to rise rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy.
The appearance of hCG in both urine and serum soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy.
The NAMADA-DxTM One-Step Pregnancy Test Device (Urine) has FDA 510(k) clearance.
The NAMADA-DxTM One-Step Pregnancy Test Device (Urine) is a rapid test that qualitatively detects the presence of hCG in urine specimen at the sensitivity of 25 µIU/mL. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine.
Principle
The test utilizes a combination of caprine polyclonal alpha hCG antibody and a monoclonal hCG antibody specific to the beta subunit of hCG to selectively detect elevated levels of hCG. The beta-hCG is conjugated to colloidal gold and the alpha-hCG is immobilized on the test region. The assay is conducted by adding a urine specimen to the specimen well of the test device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored dried conjugate of colloidal gold-monoclonal antibody. The urine reconstitutes the dried conjugate. If hCG is present in the sample, it will react with the monoclonal antibody to form a complex of colloidal gold-monoclonal antibody-hCG. This complex migrates up the membrane strip chromatographically and through the band of immobilized goat anti-hCG (alpha) antibody. Because the immobilized goat anti-hCG (alpha) is ale to bind to the hCG molecule of the migrating complex, a visible reddish band is formed along the exact location of the immobilized goat anti-hCG (alpha) antibody. If there is no hCG present in the urine sample, the colloidal gold-monoclonal antibody conjugate will pass through the immobilized hCG (alpha) band and no colored line will form – a negative result. Further up the membrane, pass the anti-hCG test region, is a control region consisting of a band of immobilized goat anti-mouse IgG. This band of antibody will bind only conjugate and form a colored line, regardless of whether hCG is present in the urine or not. Appearance of the control line assures reagent integrity as well as correct testing procedure.
