OCDX - Ortho-Clinical granted FDA authorization for Vitros COVID-19 test

Kameleon007/iStock via Getty Images The FDA has issued an Emergency Use Authorization to Ortho Clinical Diagnostics ([[OCDX]] +0.5%) for a COVID-19 test developed by the company, named VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative test, reports Bloomberg. However, the test is not indicated to diagnose the current SARS-CoV-2 infection or gauge the level of immunity following the COVID-19 vaccination. According to FDA, the quantitative serology tests “that are traceable to a certified reference material,” could help in ongoing research work aimed at studying the immune response to SARS-CoV-2. In April, Ortho Clinical announced that it received CE Marking for its VITROS SARS-CoV-2 Antigen Test. In May, the company announced the launch of Ortho's VITROS Quantitative Antibody test, which was touted as the first COVID-19 antibody test in the U.S., with the ability to provide numerical values calibrated to the World Health Organization ((WHO)) International Standard.

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Ortho-Clinical granted FDA authorization for Vitros COVID-19 test