June 2020—Ortho Clinical Diagnostics announced its COVID-19 total antibody test received the CE mark. The test offers excellent performance, with 100 percent specificity and sensitivity, and detects all COVID-19 related antibodies—IgA, IgM, and IgG.
The test runs on Ortho’s high-throughput, fully automated analyzers, including the Vitros XT 7600, Vitros 3600, and Vitros 5600, and it will soon be available on the Vitros ECi/ECiQ systems.
Ortho plans to manufacture several million COVID-19 total antibody tests each month in Rochester, NY, and Pencoed, Wales. The test received FDA EUA on April 14.
Ortho Clinical Diagnostics, 800-421-3311