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U.S. approves first self-administered coronavirus test

Christian Fernsby |
The U.S. Food and Drug Administration (FDA) said on Tuesday that it had authorized the country's first coronavirus diagnostic kit for self-testing at home.

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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 coronavirus 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 coronavirus 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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