The Food and Drug Administration has granted emergency use authorization for the first over-the-counter, at-home test that detects both COVID-19 and influenza, the agency announced Friday.
Feb 25, 2023 -- The Food and Drug Administration has granted emergency use authorization for the first over-the-counter, at-home test that detects both COVID-19 and influenza, theThe test made by Lucira Health uses a self-collected nasal swab and gives a result in about 30 minutes. In clinical studies, the test correctly identified 99% of negative and 90% of positive influenza A samples and 100% of negative and 88% of positive COVID samples.
The combo test is “a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
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