This story has been updated to reflect a revision by the US Food and Drug Administration about which product the Total Reagent Pack is cleared for use with.
NEW YORK – The US Food and Drug Administration on Monday granted marketing authorization under the de novo pathway to two QuidelOrtho COVID-19 serology tests, the agency announced in a statement.
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 Total, are intended for prescription use only. They qualitatively detect IgG antibodies to SARS-CoV-2 in human serum and plasma samples collected at least 15 days after symptom onset, the agency said. The assays are intended to help identify people with an adaptive immune response to SARS-CoV-2 from either a recent or prior infection.
Both assays received Emergency Use Authorization from the agency in April 2020.
In addition to the authorizations, the FDA also established special criteria, including required labeling and performance testing. When combined with general controls, they "provide reasonable assurance of the safety and effectiveness of serology tests" intended to detect and identify SARS-CoV-2-specific antibodies, the FDA said.