11/05/2020: Lab Alert: FDA Issues Safety Letter about Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Alert

On November 3, 2020, the U.S. Food and Drug Administration (FDA) issued a Letter to Clinical Laboratory Staff and Health Care Providers to alert clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2.

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 us at LOCS@cdc.gov.

Thank you,

The Laboratory Outreach Communication System

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

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

Centers for Disease Control and Prevention (CDC)