Federal Statute and Guidance | Covid-19 | Nov 10, 2020
FDA Issues Letter to Clinical Laboratories & Healthcare Providers on the Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2
The FDA issued a letter alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests. The guidance conveys that the FDA is aware of reports of false positive results associated with antigen tests used in nursing homes and other settings. The FDA provided recommendations for health care providers and clinical laboratory staff to help ensure accurate reporting of test results by following the authorized instructions for use of a test and key steps in the testing process as recommended by the CDC.