COVID-19 Update: FDA Continues to Advance Over-the Counter and Other Screening Test Development

On March 31, the U.S. Food and Drug Administration (FDA) authorized several COVID-19 tests for over-the-counter (OTC) use without a prescription when used for serial screening (testing asymptomatic individuals multiple times on a routine basis), such as testing twice a week in schools or other settings. The FDA also authorized serial screening tests for use in a point-of-care (POC) setting, such as a doctor’s office. These authorizations follow the FDA’s recent actions to advance OTC and other screening test development. These tests: Can be used to test people with or without COVID-19 symptoms. Are antigen tests that detect proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample. Give results in 10-30 minutes without needing to send a sample to a laboratory for analysis. Specific tests authorized yesterday: Quidel QuickVue At-Home OTC COVID-19 test - authorized for OTC at-home serial screening Abbott BinaxNOW (multiple configurations) 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 proctor 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