08/12/2022: Lab Advisory: FDA Advises Repeat Testing to Reduce False Negative Results with COVID-19 Antigen Tests

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Laboratory and Testing Professionals

Level: Laboratory Advisory

On August 11, 2022, the U.S. Food and Drug Administration (FDA) issued a safety communication which advises people to perform repeat testing following a negative result with any COVID-19 antigen self-test. COVID-19 antigen self-tests are less likely to detect the SARS-CoV-2 virus than nucleic acid amplification tests, such as polymerase chain reaction (PCR) tests. This is especially true early in an infection or for people who do not have COVID-19 symptoms.

The FDA safety communication provides specific repeat testing recommendations depending on whether you have COVID-19 symptoms. FDA also recommends that people follow up with a repeat test (such as a self-test) if they have a negative result with a point-of-care antigen test.

We encourage you to review the safety communication in detail and share this message with your networks.

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The Laboratory Outreach Communication System

Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)

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

Centers for Disease Control and Prevention (CDC)