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FDA Approves First Rapid COVID-19 Test for Home Use

WEDNESDAY, Nov. 18, 2020 -- The first rapid COVID-19 test that can be taken at home with results delivered in 30 minutes was cleared for emergency use by the U.S. Food and Drug Administration on Tuesday.

The simple nasal swab test, developed by Lucira Health, requires a prescription and people younger than 14 years old cannot perform the test on themselves, the FDA said in a statement. While Lucira ramps up manufacturing of the test, it will only be available on a limited basis in point-of-care settings and health care networks that prescribe the test for patients to use at home, the company said. By the second quarter of 2021, the company plans to amend or file a new emergency use request so people who think they are infected with COVID-19 can communicate with a medical professional online through a dedicated website to arrange a prescription and overnight delivery of the test kit.

People taking the battery-powered test swirl a nasal swab in both of their nostrils, then dip and stir the swab into a vial. That vial is then plugged into a test cartridge that processes the sample. Within half an hour, the test cartridge will light up as "positive" or "negative." Federal guidelines note that people taking the test should report the results to their health care providers, who must then inform public health authorities to help track the virus's spread.

"Today's authorization for a complete at-home test is a significant step toward FDA's nationwide response to COVID-19," Jeff Shuren, M.D., J.D., director of the FDA Center for Devices and Radiological Health, said in a statement. "Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them."

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Posted: November 2020

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