CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
July 9, 2021—Today the FDA issued an emergency use authorization to Ortho Clinical Diagnostics for the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG quantitative test.
The test measures IgG antibodies to SARS-CoV-2 from a serum or plasma sample to aid in identifying people with an adaptive immune response to SARS-CoV-2 and is for use on samples from individuals that are 15 days or more post–symptom onset. Results are traceable to the certified reference material First WHO International Standard for anti-SARS-CoV-2 immunoglobulin (human), NIBSC code 20/136.
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