The U.S. Food and Drug Administration (FDA) granted marketing authorization to two COVID-19 serology tests. The tests are the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack for use with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack for use with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator, both manufactured by Ortho-Clinical Diagnostics, Inc. These tests are intended for prescription use only for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma samples collected on or after 15 days post-symptom onset as an aid in identifying individuals who have an adaptive immune response to SARS-CoV-2 from either a recent or prior infection.
Serology tests detect the presence of antibodies to SARS-CoV-2 and do not detect the virus itself. This is one reason that serology tests should not be used to diagnose or exclude acute COVID-19 infection. The sensitivity of the COVID-19 serology tests in early infection is unknown. Negative results do not mean that the tested individual is free from an acute SARS-CoV-2 infection. If acute infection is suspected, diagnostic testing, such as a PCR or antigen test for COVID-19, is necessary.
Along with these De Novo authorizations for the two COVID-19 serology tests, the FDA established special controls (criteria), such as required labeling and performance testing. When the special controls are combined with general controls, they provide a reasonable assurance of the safety and effectiveness of serology tests intended for the detection and identification of specific antibodies to SARS-CoV-2 in clinical specimens. This action creates a new, Class II regulatory classification that may allow future devices of the same type with the same intended use to be reviewed through the FDA’s 510(k) pathway by demonstrating substantial equivalence to a predicate device.
The granting of these De Novo requests for Ortho-Clinical Diagnostics, Inc., is the latest example of the FDA’s ongoing commitment to maintain access to tests related to COVID-19.