The US Food and Drug Administration (FDA) granted marketing authorization for the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator and the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack and Calibrator, both manufactured by Ortho-Clinical Diagnostics Inc.
These are the first marketing authorizations for serology (antibody) COVID-19 tests using a traditional premarket review process, according to the FDA.
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, according to the FDA. The sensitivity of the 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.
“Our Vitros Anti-SARS-CoV-2 Total test and Vitros Anti-SARS-CoV-2 IgG test help assess immune response to SARS-CoV-2 to help healthcare workers and patients understand and manage this disease,” says Douglas Bryant, president and CEO of QuidelOrtho Corp, in a release. “QuidelOrtho was the first company to receive de novo classification for SARS Antigen+ FIA and, just a few weeks later, is again the first to receive de novo classification for not one, but two COVID-19 antibody tests, solidifying our expertise and leadership in diagnostic testing for respiratory diseases.”
The Vitros Anti-SARS-CoV-2 Total assay and Vitros Anti-SARS-CoV-2 IgG assay are processed on QuidelOrtho’s Vitros Systems.