While testing has become more readily available since the coronavirus first struck in March, it’s now going to be even more accessible: from the comfort of your own home.
The Food and Drug Administration just authorized the first coronavirus test that can be self- administered entirely at home.
The COVID-19 All-In-One Test Kit, made by Lucira Health, is administered by a self-collected nasal swab, which is then put into a sample vial. Users will be able to see their results on a screen in 30 minutes or less, according to the FDA’s news release.
Quick, easy and safe.
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
“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.”
Nearly 300 coronavirus tests have been authorized by the FDA so far, the majority of which must be administered at a testing site before being shipped to a lab for processing. A few allow the nasal swab or saliva sample to be collected at home, but those tests still must be sent to a lab and individuals often wait days for results.
This revolutionary form of testing will allow for quick and easy results without the risk of transmitting the disease at a doctors office or testing site.
The emergency use authorization issued by the FDA currently only allows the at-home test to be given via prescription to individuals 14 and older. It can be used at hospitals, doctors offices, urgent care facilities, and other coronavirus testing sites for all ages, but the sample must be collected by a healthcare provider.
“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.”
