FDA issues emergency use authorization for second SARS-CoV-2 antigen test: BD Veritor System

A second COVID-19 antigen diagnostic test has been added to the United States arsenal this week, under an emergency use authorization (EUA) issued by the U.S. Food and Drug Administration (FDA) for the Becton Dickinson (BD) Veritor System.

“Expanding America’s testing capabilities is the result of partnership and ingenuity between the federal government, private sector, and academia,” FDA Commissioner Stephen Hahn said. “Today’s authorization is another achievement of that work. Antigen tests play an important role in the overall response against COVID-19, including as a point-of-care test that can potentially scale up to test millions of Americans quickly.”

Meant as a rapid detection test for the SARS-CoV-2 virus, which causes COVID-19, the test was authorized for use by labs certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for high, moderate or waived complexity testing. If patient care settings have a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation, they can now use the test.

There are limitations, though. The test is reserved exclusively for those authorized labs using the BD Veritor Plus Analyzer Instrument. That instrument is a handheld device that, until now, has been utilized for testing other viruses such as the Flu, Group A Strep, and respiratory syncytial virus (RSV).