The first over-the-counter, fully at-home COVID-19 antigen test kit has been approved for emergency use by the Food and Drug Administration.
The approval allows the Ellume COVID-19 Home Test to be sold at retail without a prescription. Results are available in about 20 minutes via a mobile phone app, and the test is more than 90% accurate in both symptomatic and asymptomatic people, the agency announced Tuesday.
To conduct the test, users insert a nasal swab sample into a single-use analyzer cartridge. The analyzer connects to the user’s smartphone through Bluetooth, and pairs with a downloadable app that provides step-by-step instructions. It then displays the results.
The application requires users to input their zip code and birth date, and shares results with public health authorities to monitor disease prevalence. It also allows users to share the results with employers or others as needed, according to the National Institutes of Health, which funded the product through a fast-tracked diagnostics development initiative.
While the FDA has green-lit about 25 tests for COVID-19 that can be used in the home, the other tests require a prescription, or that samples be sent to a lab.
The Ellume kit helps test for protein markers called antigens, a sign that someone is carrying SARS-CoV-2, the virus that causes COVID-19. Ellume, of Valencia, CA, said it expects to produce more than three million tests in January 2021. The kit will cost about $30.
“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,” said FDA Commissioner Stephen M. Hahn, M.D., in a statement accompanying the announcement.