The United States Food and Drug Administration granted emergency use authorization (EUA) for the first over-the-counter COVID-19 testing kit available at home.
The Ellume COVID-19 Home Test is a rapid antigen test, which runs a liquid sample along a surface with reactive molecules. The test detects minuscule parts of proteins of the coronavirus via a nasal swab sample. Anyone two years or older can take the test.
“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,” FDA Commissioner Stephen M. Hahn said.
“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.”
The test uses an analyzer that connects to an app on a smartphone to help people perform the test and understand the results. Results come back in as little as 20 minutes to individuals via their smartphone. The smartphone app requires users to put in their zip code and birthday, with optional fields such as name and e-mail address.
As cases continue to rise around the nation despite the first people receiving vaccinations, these at-home tests could become more prevalent than ever in the coming months to mitigate the risk of going to a testing site. Instead, you can stay at home and still get results straight to a smartphone. Of course, you will want to get multiple tests to confirm a negative or positive test, but a suitable approach is to start with the at-home kit. Ellume estimates that 3,000,000 kits will be available in the coming months for those who want to test at home. With Christmas around the corner, these additional tests could be essential.
For more information on how to help slow the spread of COVID-19, please consult your local and state government officials.
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