FDA authorizes first coronavirus self-test in US

Health

Published: 2020-11-18 15:30

Last Updated: 2021-02-28 04:35


FDA authorizes first coronavirus self-test in US
FDA authorizes first coronavirus self-test in US

The US Food and Drug Administration Wedesday approved the first self-testing COVID-19 kit that gives results in 30 minutes. The authorization was issued to Lucira Health for their emergency use all-in-one test kit, meant for individuals aged 14 or older.

Many coronavirus tests allow people to provide samples from home but this is the first test that provides results at home within 30 minutes.

"This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission," FDA Commissioner Stephen Hahn said.

The test was only authorized for prescription use and is single-use. Users must swirl the swab in a vial then insert it in the test unit, after which the results will show on the test's light-up display.

The product was also authorized for use in doctor’s clinics, emergency rooms and hospitals.