The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests for the virus that causes COVID-19.
The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests for the virus that causes COVID-19. In a letter to stakeholders, the FDA said Tuesday that while antigen tests can be used for the rapid detection of SARS-CoV-2, false positive results can occur, especially if users don’t follow the instructions. “The FDA is aware of reports of false positive results associated with antigen tests used in nursing homes and other settings and continues to monitor and evaluate these reports and other available information about device safety and performance,” the letter said.
