The Food and Drug Administration has approved the first over-the-counter diagnostic test for COVID-19.
The FDA issued an emergency use authorization Tuesday for the Ellume COVID-19 Home Test. Ellume Health, a developer of diagnostic medical tests based in Australia, says the test can be used anywhere and returns results in 15 minutes.
It employs nasal swabs to test for fragments of coronavirus proteins. The results are then sent to the user’s smartphone. It can be used to test anyone age 2 or older.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen Hahn. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”
