FDA Authorized Antibody Tests
Serology tests detect the presence of antibodies in the blood when the body is responding to a specific infection, like COVID-19. In other words, the tests detect the body’s adaptive immune response to the infection caused by the virus rather than detecting the virus itself. Below you can find a list of FDA authorized manufacturers that have notified FDA that they have validated and intend to distribute serology tests.
- Abbott Laboratories SARS-CoV-2 IgG (for use on ARCHITECT):
- Autobio Diagnostics’ Anti-SARS-CoV-2 Rapid Test:
- FDA Authorization information
- Product information
- Chembio Diagnostic Systems, Inc. DPP COVID-19 IgM/IgG System:
- Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator
Visit FDA’s webpage for more information on EUA authorized serology test performance.