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Ortho Clinical, Autobio Diagnostics Coronavirus Antibody Tests Granted Emergency Use Authorizations

NEW YORK — The US Food and Drug Administration on Friday granted separate Emergency Use Authorizations (EUAs) for SARS-CoV-2 immunoassays developed by Ortho Clinical Diagnostics and Autobio Diagnostics.

Ortho's test is designed to detect SARS-CoV-2-associated immunoglobulin G (IgG) antibodies in human serum in order to identify individuals with adaptive immune responses to the virus. It is performed using the company's Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack and associated calibrator, and runs on the Vitros ECi/ECiQ/3600 Immunodiagnostic System and the Vitros 5600/XT 7600 Integrated System.

According to the FDA, the test can be performed by any lab CLIA-certified to perform moderate- to high-complexity tests.

Earlier this month, Ortho was granted an EUA for its total COVID-19 antibody test, which detects all virus-related antibodies including IgG and immunoglobulin M (IgM). The Raritan, New Jersey-based company said that both tests have demonstrated 100 percent specificity.

Autobio's Anti-SARS-CoV-2 Rapid Test is a lateral flow immunoassay designed for the qualitative detection and differentiation of SARS-CoV-2-associated IgG and IgM antibodies in human plasma or serum to help identify individuals with recent or prior infections.

In March, Zhengzou, China-based Autobio partnered with Hardy Diagnostics to distribute the test in the US.