Attention: Clinical Laboratory Professionals

Please share the following with:
Medical Director, Laboratory Services
Lab Manager(s)

On November 3, 2020, the U.S. Food and Drug Administration (FDA) issued a Letter to Clinical Laboratory Staff and Health Care Providers as an alert that false positive results can occur with antigen tests, including when users do not follow the instructions for use.

This letter includes important information about potential false positive results with antigen tests for rapid detection of SARS-CoV-2:

  • Details on false positive results with antigen tests
  • Recommendations for health care providers and clinical laboratory staff
  • Actions FDA is taking
  • Instructions for reporting problems with a device

For questions about this letter, email COVID19DX@fda.hhs.gov.

Online resources:

If you have any questions, please contact info@hfap.org.