April 27, 2020—Ortho Clinical Diagnostics announced the FDA granted emergency use authorization to its second COVID-19 antibody test, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test. The test demonstrated 100 percent specificity and runs on Ortho’s high-throughput, fully automated analyzers including its Vitros XT 7600 integrated system, the Vitros 3600 immunodiagnostic system, and the Vitros 5600 integrated system; it will soon be available on Vitros ECi/ECiQ immunodiagnostic systems.
Ortho plans to manufacture several million COVID-19 IgG antibody tests each month.