01/06/2021: Lab Alert: FDA Issues Safety Communication about Risk of False Results with the Curative SARS-CoV-2 Test for COVID-19
Audience: Clinical Laboratory Professionals
Level: Laboratory Alert
On January 4, 2021, the U.S. Food and Drug Administration (FDA) issued a safety communicationexternal icon about the risk of false negative results with the Curative SARS-CoV-2 test for COVID-19.
To reduce the risk of false negative results, the test should be performed according to the instructions for use. Refer to the safety communication for more specific guidance, and please share this message with your partners and colleagues who perform testing for SARS-CoV-2.
FDA encourages stakeholders to report adverse events or suspected adverse events, including problems with test performance or results, through MedWatchexternal icon, the FDA Safety Information and Adverse Event Reporting program. Please direct any questions to the FDA Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV.
- Guidance for SARS-CoV-2 Point-of-Care Testing
- Interim Guidance for SARS-CoV-2 Antigen Testing
- Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19
- Frequently Asked Questions about COVID-19 for Laboratories
- Information for Laboratories about COVID-19
- CDC COVID-19 Website
- Clinical Laboratory COVID-19 Response Weekly 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.