The test uses the principle of colloidal gold immunochromatography and capture method to detect COVID-19 (SARS-CoV-2) IgM and IgG antibodies in human serum, plasma, and whole blood. When the sample contains COVID-19 IgM / IgG antibody and the concentration is greater than or equal to the minimum detection limit, the antibody binds to the antigen immobilized on colloidal gold nanoparticles which migrate to test region 1 (T1) / test region 2 (T2), where it is captured by the secondary antibody to produce a red reaction line. The result is considered positive when a red reaction line appears in either test region. The result is considered negative when no red reaction line is in test line region. The test is valid when the control line (C) produces a reaction line and invalid if no control line (C) appears.
Key Features and Benefits
Nirmidas has notified the FDA that we have validated and are offering our serology test, Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit, to commercial laboratory and for POCT settings, in compliance with Section IV.D. of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 . The FDA has not reviewed the Nirmidas’ validation of this test. Nirmidas will be pursuing EUA of this test.
If you have any queries regarding the product, please contact us.