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

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.

Opt in to receive updates from the CDC Laboratory Outreach Communication System (LOCS).

Online resources:

• Guidance for Antigen Testing for SARS-CoV-2 for Healthcare Providers Testing Individuals in the Community
• Guidance for SARS-CoV-2 Rapid Testing Performed in Point-of-Care Settings
• Self-Testing at Home or Anywhere
• CDC Laboratory Outreach Communication System (LOCS)

Questions?

• 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.

Thank you,

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)

LOCS@cdc.gov

www.cdc.gov/locs