The U.S. Food and Drug Administration (FDA) approved amended emergency use authorization (EUA) requests for multiple tests this week, expanding over-the-counter and point-of-care testing options for COVID-19, the agency said in a news release.
“The addition of the OTC and POC tests for screening will give schools, workplaces, communities and others several options for serial screening tests that are accurate and reliable,” the FDA said.
The authorizations the FDA approved are:
· Quidel QuickVue At-Home OTC COVID-19 test - authorized for OTC at-home serial screening
· Abbott BinaxNOW COVID-19 Antigen Self Test – authorized for OTC at-home serial screening
· Abbott BinaxNOW COVID-19 Ag Card 2 Home Test – authorized for OTC at-home serial screening with telehealth
· Abbott BinaxNOW COVID-19 Ag 2 Card – authorized for POC serial screening without a prescription
· BD Veritor System for Rapid Detection of SARS-CoV-2 – authorized for POC serial screening with a prescription
The FDA said that the tests had been previously authorized by the agency (some under different names) to test those with COVID-19 symptoms, but the actions this week authorize testing of asymptomatic individuals when used for serial testing.
