US FDA approves first Covid-19 test kit for home use

Reuters | Updated on November 18, 2020 Published on November 18, 2020

November 17 The US Food and Drug Administration said on Tuesday it had approved the first Covid-19 self-testing kit for home use, that provides results within 30 minutes.

The single-use test, made by Lucira Health, has been given emergency use authorisation for home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of Covid-19 by their healthcare provider, the FDA said.

“While Covid-19 diagnostic tests have been authorised for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Stephen Hahn said.

The kit can also be used at hospitals and point-of-care settings, but samples should be collected by a healthcare provider if the individuals who are tested are younger than 14 years, the health regulator said.

ALSO READ: Covid-19: Cipla in pact with Belgium firm to bring in rapid antibody test kit

Although a recent string of positive news from Moderna Inc and Pfizer Inc on their potential vaccines has raised hopes in combating the disease, testing still is a key factor in controlling the spread of the virus.

“We look forward to proactively working with test developers to support the availability of more at-home test options,” said Jeff Shuren, the director of the FDA’'s Center for Devices and Radiological Health.

ALSO READ: ‘We can stop Covid-19’: Moderna vaccine success gives world more hope

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Published on November 18, 2020
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