The U.S. Food and Drug Administration (FDA) on Friday granted de novo requests for two COVID-19 serology tests manufactured by QuidelOrtho.
The agency granted marketing authorization for the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack for use with the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator.
It also granted marketing authorization for the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack for use with the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total and with the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator.
The tests are intended for prescription use only and 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; they are specifically indicated to help identify patients who have an adaptive immune response to SARS-CoV-2 from either a recent or prior infection.
In a statement, the FDA added that serology tests such as these detect the presence of antibodies to SARS-CoV-2 and not the virus itself. Therefore, they should not be used to diagnose or exclude acute COVID-19 infection. If acute infection is suspected, antigen or polymerase chain reaction (PCR) testing should be performed.
The agency noted that these are the first marketing authorizations for serology COVID-19 tests using a traditional premarket review process, and that the granting of the de novo request is the latest example of the FDA's ongoing commitment to maintain access to tests related to COVID-19.
