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2020.11.18 16:48 GMT+8

U.S. approves first self-administered COVID-19 test

Updated 2020.11.18 16:48 GMT+8

The U.S. 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 under 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 healthcare 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.

Source(s): Xinhua News Agency
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