The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic.
Following recent FDA actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market.
On March 31, the 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.
- 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.