Rapid SARS-CoV-2 Antigen Test Card

Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in nasal swabs, nasopharyngeal swabs or oropharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Rapid SARS-CoV2 Antigen Test Card cannot be used as the sole basis to diagnose or exclude SARS-CoV-2 infection.

Rapid SARS-CoV-2 Antigen Test Card is an immunochromatographic lateral flow device that employs the principle of the double antibody sandwich method. Colloidal gold conjugated anti-SARS-CoV-2 antibodies are dry-immobilized on the test device. When the specimen is added, it migrates by capillary diffusion through the strip to re-hydrate the gold conjugate complexes. If present at or above the limit of detection, SARS-CoV-2 viral antigens will react with the gold conjugate complexes to form particles, which will continue to migrate along the strip until the Test Zone (T) where they are captured by the immobilized anti-SARSCoV-2 antibodies to form a visible red line. If there are no SARS-CoV-2 viral antigens in the specimen, no red line will appear in the Test Zone (T). The gold conjugate complexes will continue to migrate alone until being captured by immobilized antibody in the Control Zone (C) to form a red line, which indicates the validity of the test