The U.S. Food and Drug Administration (FDA), said on Tuesday that it had authorised 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 corona virus — 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 authorised 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 authorised 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 authorised for prescription use only.
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