WASHINGTON — The U.S. Food and Drug Administration granted emergency use authorization late Tuesday for the first COVID-19 diagnostic at-home self-test kit.
We continue to demonstrate unprecedented speed in response to #COVID19. FDA authorized the first #COVID19 test that’s fully self-administered & provides results at home. It’s an important advancement, underscoring our commitment to expanding test access. https://t.co/pgoSbvTLYy pic.twitter.com/cF75XHcNMg
— Dr. Stephen M. Hahn (@SteveFDA) November 18, 2020
The Lucira COVID-19 All-In-One Test Kit is a molecular single-use test that provides rapid results, the agency stated 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 Stephen Hahn said in the statement.
“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” he added.
According to NPR, the test works by swirling the self-collected sample in a vial that is then placed in a test unit, which can provide results in 30 minutes or fewer. A light-up display then tells the individual if they have tested positive or negative for the novel coronavirus.
The FDA stated the tests will be available by prescription to people 14 and older who have symptoms that could indicate COVID-19. Meanwhile, patients under the age of 14 can still receive a kit, but the test must then be administered by a health care provider.
According to Lucira’s website, the test is “intended to cost less than $50” and is manufactured in the United States.
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Cox Media Group
