Ortho Clinical Diagnostics Gets FDA EUA For Updated VITROS SARS-CoV-2 Antigen Test - Quick Facts

(RTTNews) - Vitro diagnostics company Ortho Clinical Diagnostics (OCDX) announced Tuesday that it received authorization from the U.S. Food and Drug Administration (FDA) to update key claims for the VITROS SARS-CoV-2 Antigen Test, the first high-volume SARS-CoV-2 antigen assay to receive Emergency Use Authorization (EUA) in the United States.

The test has now received the FDA's EUA for new improved sensitivity data, updated specimen collection methods and additional viral transport media.

Authorized for use in the U.S. in January 2021, Ortho's VITROS SARS-CoV-2 Antigen Test offers reliable detection of SARS-CoV-2 in patients suspected of COVID-19 by their healthcare provider within seven days of the onset of symptoms with high sensitivity and specificity.