2 new antibody tests get FDA clearance

2016 09 02 09 36 05 93 Fda Logo V2 400

The U.S. Food and Drug Administration (FDA) has issued emergency use authorization (EUA) for two new tests that detect the presence of antibodies to the virus that causes COVID-19.

The authorizations were issued to Ortho Clinical Diagnostics for its Vitros Immunodiagnostic Products Anti-SARS-CoV-2 total reagent pack and Chembio Diagnostic Systems for its DPP COVID-19 IgM/IgG system.

Both serology tests can detect immunoglobulin M/immunoglobulin G (IgM/IgG) antibodies from serum or plasma samples of patients suspected of having COVID-19. The DPP COVID-19 IgM/IgG system can also detect antibodies in venous whole blood or whole blood specimens.

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