FDA authorises first over-the-counter Covid-19 antigen test

Reuters | Updated on December 16, 2020

December 16 The US Food and Drug administration on Tuesday authorised the 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 analyser 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.

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The news follows authorisation 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.

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 US within the first half of 2021.

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Published on December 16, 2020

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