Saturday, September 18, 2021

US authorities approve home Covid-19 test kit for over-the-counter sale

This test is the first that does not require people's swabs to be sent to a lab for analysis.

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The US Food and Drug Administration (FDA) on Tuesday approved the first Covid-19 test anyone can buy from a pharmacy, take home and get almost instant results from.

It includes a nasal swab and gives results in around 20 minutes, reports the New York Post.

“Today’s authorisation is a major milestone in diagnostic testing for Covid-19,” said Stephen Hahn, the FDA commissioner on the agency’s website.

“By authorising 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 in as little as 20 minutes.’’

The FDA has already approved more than 25 at-home consumer coronavirus tests but until now, the collected samples had to be sent away to a lab for results.

The diagnostics company Ellume makes the new completely at-home test.

“There are drawbacks to this test but its development is still a major step forward in diagnosing the virus,” said Jeff Shuren, the FDA’s director of its 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,” Shuren said. “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.”

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