FDA Authorizes COVID-19 Tests for Over-the-Counter or Point-of-Care Use

The FDA has authorized several over-the-counter (OTC) COVID-19 tests for at-home use, as well as separate tests for point-of-care use.

Quidel’s QuickVue At-Home OTC COVID-19 test and Abbott’s BinaxNOW COVID-19 Antigen Self Test were authorized for OTC at-home use.

Abbott’s BinaxNOW COVID-19 Ag Card 2 Home Test was cleared for OTC at-home screening with the help of a telehealth proctor. Another Abbott test, the BinaxNOW COVID-19 Ag 2 Card, was authorized for point-of-care serial screening without a prescription.

Becton Dickinson received authorization from the agency for its Veritor System for Rapid Detection of SARS-CoV-2, allowing its use in point-of-care screening with a prescription.