US FDA authorizes first COVID-19 test for self-testing at home
Dr. Vincent Carrao swabs a patient's nose for the coronavirus disease (COVID-19) test at Palisades Oral Surgery, in Fort Lee, New Jersey, U.S., June 15, 2020. REUTERS/Brendan McDermid
NEW YORK: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 age 14 and older who are suspected of COVID-19 by their health care 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 Hahn said.
The kit can also be used at hospitals but samples should be collected by a healthcare provider if the individuals who are tested are younger than 14 years, the health regulator said.Enable Ginger Cannot connect to Ginger Check your internet connection
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