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The Food & Drug Association (FDA) authorized a rapid at-home COVID-19 test on Dec. 15, reports the Washington Post. The test, made by Australian company Ellume, is the first in the U.S. that can be bought over the counter with no prescription. Even better? It'll cost around $30.
“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."
FDA Commissioner Dr. Stephen M. Hahn M.D.
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The Ellume isn't as accurate as lab tests, but it’ll be convenient. "The fact that it can be used completely at home and return results quickly means that it can play an important role," FDA's Director of the Center for Devices & Radiological Health, Dr. Jeff Shuren M.D., said.
The Ellume test identified 96% of positive samples and 100% of negative samples in people with symptoms, per the FDA. In asymptomatic people, it identified 91% of positive samples and 96% of negative ones.
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