US FDA approves 1st COVID-19 home-testing kit, gives results withing 30 minutes

The first COVID-19 testing kit for home use that gives results in 30 minutes was approved by the U.S. Food and Drug Administration on Tuesday.

The testing kit made by Lucira Health has been given emergency use authorisation for home use with self-collected nasal swab samples in individuals aged 14 and older, suspected of COVID-19 by their health care provider for the single-use test, 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 Hahn said.

The kit can also be used at hospitals and point-of-care settings but samples should be collected by a healthcare provider if the individuals who are tested are younger than 14 years, the health regulator said.

“We look forward to proactively working with test developers to support the availability of more at-home test options,” said Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health.

A recent string of positive news from Moderna Inc and Pfizer Inc on their potential vaccines has raised hopes in combating the disease, testing still is a key factor in controlling the spread of the virus.