The Food and Drug Administration (FDA) authorized the first coronavirus test that can be performed entirely at home Tuesday.
The COVID-19 All-In-One Test Kit, manufactured by the California-based company Lucira Health, is administered by a self-collected nasal swab, which is then put into a sample vial. Users can see the tet results on a light-up screen in 30 minutes or less, the FDA said in a news release.
“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 Dr. Stephen M. Hahn said. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.” (RELATED: ‘Something Extremely Bogus Is Going On’ — Elon Musk Tests Both Positive And Negative For COVID-19 On Eve Of SpaceX Launch)
Today, we issued an emergency use authorization (EUA) for the first #COVID19 diagnostic test that allows for self-collection & testing at home and provides test results in 30 minutes or less. The test kit for home use is available by prescription only. https://t.co/EXzSa8JyFR pic.twitter.com/Wooy5YBIbZ
— U.S. FDA (@US_FDA) November 18, 2020
Nearly 300 coronavirus tests have been authorized by the FDA so far, the majority of which must be performed at the coronavirus testing site before being shipped to a lab, the Associated Press reported. A few allow the nasal swab or saliva sample to be collected at home, but those tests must be sent out to a lab, meaning individuals often wait days for results.
The emergency use authorization (EUA) issued by the FDA only allows the at-home test to be available by prescription for individuals ages 14 and up. It can be used at hospitals, doctor’s offices, urgent care facilities, and other coronavirus testing sites for all ages, but the sample must be collected by the healthcare provider.
When compared with a high-sensitivity FDA-approved coronavirus test, Lucira’s at-home test had a 94% positive percent agreement rate and a 98% negative percent agreement rate, according to the company’s website.
“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said. “A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic.”
“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” Shuren added. “We look forward to proactively working with test developers to support the availability of more at-home test options.”