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
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 Providersexternal icon 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.
- Interim Guidance for Rapid Antigen Testing for SARS-CoV-2
- Interpreting Results of Diagnostic Tests
- COVID-19 Information for Laboratories
- Frequently Asked Questions about COVID-19 for Laboratories
- CDC COVID-19 website
- Clinical Laboratory COVID-19 Response Calls
- CDC Laboratory Outreach Communication System (LOCS)
- Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign up
If you have any questions, please contact us at LOCS@cdc.gov.
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)