11/01/2022: Lab Advisory: FDA Updates COVID-19 Antigen Tests – EUA Revision for Repeat Testing
Audience: Laboratory and Testing Professionals
Level: Laboratory Advisory
On November 1, 2022, the U.S. Food and Drug Administration (FDA) updated the emergency use authorizations (EUAs) of all COVID-19 antigen tests to revise the authorized uses and require updates to product labeling regarding repeat or serial testing. The letter also eliminates a Condition of Authorization concerning the collection of additional data to evaluate the performance of authorized antigen in vitro diagnostics for serial testing.
The EUA revision requires test developers to
- Update product labeling to include the revised authorized uses:
- Repeat testing at least 2 times over 3 days with at least 48 hours between tests for people with COVID-19 symptoms.
- Repeat testing at least 3 times over 5 days with at least 48 hours between tests for people without COVID-19 symptoms.
- Submit a supplemental EUA request to the FDA with the updated labeling.
Please review FDA’s revised In Vitro Diagnostics EUAs – Antigen Diagnostic Tests for SARS-CoV-2 web page and share this message with your networks.
- If you are a clinical or public health laboratory professional, contact LOCS.
- For media inquiries, contact the CDC Newsroom.
- For all other questions, contact CDC-INFO.