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FDA Approves First Over-the-Counter Fully At-Home Test for COVID-19

TUESDAY, Dec. 15, 2020 -- The first nonprescription COVID-19 test that enables people to collect samples and get results at home has received emergency use authorization from the U.S. Food and Drug Administration.

Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results. The new Ellume COVID-19 Home Test approved Tuesday detects severe acute respiratory syndrome coronavirus 2 virus protein fragments on nasal swab samples from any person 2 years of age or older, according to the FDA. The test uses an analyzer that connects with a smartphone app to help users perform the test and interpret results. Results are delivered by smartphone in as little as 20 minutes.

According to Jeffrey Shuren, M.D., director of the FDA Center for Devices and Radiological Health, "This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic."

In testing, the Ellume COVID-19 Home Test correctly identified 96 percent of positive samples and 100 percent of negative samples in people with symptoms. In people without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples.

Ellume expects to produce more than 3 million tests in January 2021, the FDA said.

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Posted: December 2020

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