Per the notice below, the United States Food and Drug Administration (FDA) has revised the criteria for an emergency use authorization (EUA) for repeat testing using novel coronavirus (COVID-19) antigen tests.
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COVID-19 Antigen Tests: EUA Revision for Repeat Testing
Today, FDA revised 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 issued today also eliminates one Condition of Authorization that is no longer needed. Today’s action is in response to available data about the performance of COVID-19 antigen tests showing that repeat testing after a negative COVID-19 antigen test result increases the chance of an accurate result, in people with and without symptoms, and could help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The EUA revision requires test developers in the scope of the revision 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.
Questions?
If you have questions about this EUA revision, e-mail: COVID19DX@fda.hhs.gov.
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