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November 05, 2020

FDA Warns of False Positive COVID-19 Antigen Test Results

The FDA informed clinical laboratory staff and other healthcare providers Tuesday that false positives can occur when users do not follow the instructions for the use of antigen tests for rapid detection of SARS-CoV-2.  The FDA issued the first emergency use authorization (EUA) for a COVID-19 antigen test in May. The U.S. government has entered into agreements with several companies, including Becton Dickinson and Quidel Corp., to supply antigen tests to U.S. nursing homes.