US FDA Announces New, Prescription-free At-home COVID Test

A new, over-the-counter, at-home COVID test has been approved in the United States. The U.S. Food and Drug Administration made the announcement about the emergency use authorization of the “rapid” test on Tuesday. “Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D., in a news release. Last month, the FDA approved a prescription at-home test. The FDA said it has approved more than 225 COVID-19 tests since the start of the pandemic. The newly approved test uses a nasal swab, much like many other tests, but the FDA said it is not as invasive as some of the tests seen in the media. It added that the test correctly identifies 96% of cases in which people have symptoms. For those with no symptoms, it does give a “small percentage” of false positives, much as other tests do, the FDA said. The test “uses an analyzer that connects with a software application on a smartphone to help users perform the test and interpret results,” according to the FDA. The results come “in as little as 20 minutes,” it added.  
 

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