FDA Accepts Ortho Clinical’s EUA Request for COVID-19 Test
The FDA has accepted Ortho Clinical’s Emergency Use Authorization request for the Vitros SARS-CoV-2 Antigen test, a COVID-19 diagnostic that’s already been cleared in Europe.
The company said the test can serve as a “viable alternative” to real-time polymerase chain-reaction testing for individuals with known or suspected exposure to SARS-CoV-2 who show symptoms suggestive of viral infection. The test offers a 97.8 percent sensitivity and 99.2 percent specificity.
The test runs on Ortho’s Vitros platform, using swab samples that can be stored at room temperature for up to two days and will become available worldwide in large supply this month.