The Food and Drug Administration granted emergency use authorization to the first over-the-counter antigen test for COVID-19 that can be used at home in individuals ages 2 and up, including those not showing symptoms.
The approval comes a week after the agency approved another non-prescription, at-home test, but that one requires samples to be sent to an outside lab.
With the Ellume COVID-19 Home Test, patients collect a mid-turbinate nasal swab to detect virus antigens. The test uses an analyzer that is connected with a software application on a smartphone to help users perform the test and interpret results in as little as 20 minutes, according to the FDA press release.
The test has boasted a 96% accuracy rating in positive samples taken from symptomatic people, and 100% of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91% of positive samples, and 96% of negative samples.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen Hahn, M.D., said in the press release. “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. 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.”
To date, the FDA has authorized more than 225 diagnostic tests for COVID-19, including 25 tests that involve at-home sample collection, but require the samples to then be sent to a lab.
The company said it expects to produce upwards of three million tests in 2021.