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.
- 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)
- 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.