FDA authorizes first over-the-counter COVID-19 antigen test

(Reuters) – The U.S. Food and Drug Administration on Tuesday authorized emergency use of the first over-the-counter COVID-19 antigen test, which can be used at home.

The test by Ellume offers a nasal swab analyzer that connects to a software application on users’ smartphone, and gives results in 20 minutes.

Anyone above two years of age, including those not showing symptoms, can take the test, the agency said.

The news follows authorization of the first prescription COVID-19 test for home use last month, and of a non-prescription test system allowing a lab to process nasal samples collected at home, last week.

The regulatory nods will help expand Americans’ access to testing, reduce the burden on laboratories and test supplies, and give more testing options, FDA Commissioner Stephen Hahn said in a statement.

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

The agency, however, cautioned that like other antigen tests, a small percentage of results from the test may be false.

Ellume said it will be shipping over 100,000 tests per day from next month, and plans to manufacture as well as deliver 20 million COVID-19 tests to the United States within the first half of 2021.


Reporting by Amruta Khandekar; Editing by Shinjini Ganguli


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