11/01/2022: Lab Advisory: FDA Updates COVID-19 Antigen Tests – EUA Revision for Repeat Testing

CDC's Laboratory Outreach Communication System (LOCS)

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

  1. 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.
  1. 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.

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The Laboratory Outreach Communication System

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Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)