A new coronavirus disease (COVID-19) at-home test kit made by Lucira Health, newly approved by the U.S. Food and Drug Administration for emergency use authorization, sits on a table at a Sutter Health lab in San Carlos, California, U.S. November 18, 2020. REUTERS/Nathan Frandino
The U.S. Food and Drug Administration said on Tuesday it had approved the first COVID-19 self-testing kit for home use that provides results within 30 minutes.
The single-use test, made by Lucira Health, has been given emergency use authorization for home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their health care provider, the FDA said.
鈥淲hile 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,鈥� 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.
Although 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.
鈥淲e look forward to proactively working with test developers to support the availability of more at-home test options,鈥� said Jeff Shuren, the director of the FDA鈥檚 Center for Devices and Radiological Health.
The United States crossed 11 million total infections on Sunday, just eight days after reaching the 10 million mark.