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FDA Grants Emergency Use Authorization for Ortho-Clinical SARS-CoV-2 Quantitative Antibody Assay

NEW YORK — The US Food and Drug Administration on Friday granted Emergency Use Authorization to Ortho-Clinical Diagnostics' Vitros Anti-SARS-CoV-2 IgG Quantitative test.

The chemiluminescent immunoassay is designed for the qualitative and quantitative detection of immunoglobulin G against SARS-CoV-2 in serum and plasma to aid in the identification of individuals with an adaptive immune response to the virus. It is only authorized for use with samples from individuals 15 or more days after symptom onset.

The assay, which FDA said should not be used for diagnostic purposes, is the first quantitative serology test for SARS-CoV-2 to receive EUA, the FDA said. The agency also said that the assay should not be used to assess an individual's immunity to SARS-CoV-2 after getting a vaccine or to assess an individual's need to get vaccinated for the coronavirus.

It runs on Raritan, New Jersey-based company's Vitros ECi, ECiQ, 3600, 5600, and XT 7600 systems and may be used by any lab CLIA-certified to perform moderate- or high-complexity tests.