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 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 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 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.