WASHINGTON — The U.S. Food and Drug Administration has granted emergency use authorization for the first at-home COVID-19 self-test kit.
The all-in-one test kit, developed by Lucira Health, detects the virus’ genetic material, and can provide results within 30 minutes.
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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
The tester uses a swab in each nostril five times before the swab is stirred in a sample vial to start the test.
A light-up display on the test unit will say whether it’s negative or positive.
Lucira expects the single-use tests to cost around 50 dollars each.
Some retailers have already been selling at-home tests, but those aren’t FDA approved, and they require the user to send them back for results.
Lucira says their test will at first only be available on a limited basis through healthcare networks that prescribe the test.
FDA continues to reaffirm our commitment to transparency around the emergency use authorization (EUA) process and noted yesterday our plan to provide more info about decisions to issue, revise or revoke EUAs for drugs/biological products, incl. vaccines. https://t.co/6scSI6AFBP
— Dr. Stephen M. Hahn (@SteveFDA) November 18, 2020
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They hope to make it more widely available to the public by the spring.
The FDA has also authorized the test for use in doctor’s offices, hospitals, and urgent care centers.
FDA Authorizes First Prescription At Home Molecular Test for COVID-19, and Lucira Health test provides lab-quality result in 30 minutes or less from home. https://t.co/xO74SSHExk pic.twitter.com/ILzuQTE4Lh
— Lucira Health (@LuciraHealth) November 18, 2020
Cox Media Group