WORLD US approves first self-administered COVID-19 test

WORLD

US approves first self-administered COVID-19 test

Xinhua

17:25, November 18, 2020

A man gets a COVID-19 test administered by a member of the Wisconsin National Guard at a COVID-19 test center set up at Miller Park on Nov 17, 2020 in Milwaukee, Wisconsin. (Photo: Agencies)

WASHINGTON - The US Food and Drug Administration (FDA) said on Tuesday that it had authorized the country's first COVID-19 diagnostic kit for self-testing at home.

Users can collect a sample with nasal swabs included in the all-in-one test kit and swirl the swab in a vial. In at most 30 minutes, the results -- whether a person is positive or negative for the novel coronavirus -- can be read from the test unit's light-up display, the FDA said in a statement.

The test kit, made by Lucira Health, has been authorized for home use for individuals aged 14 and older who are suspected of COVID-19 by their health care provider.

The test can also be used in point-of-care (POC) settings -- emergency rooms or hospitals for example -- for all ages, but samples of those younger than 14 must be collected by a healthcare provider, the FDA said.

"While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home," FDA Commissioner Stephen M. Hahn said.

The single-use test is currently authorized for prescription use only.

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