FDA Authorizes 1st Home Coronavirus Test That Doesn't Require A Prescription

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic

FDA Authorizes 1st Home Coronavirus Test That Doesn't Require A Prescription The new tests produce results completely at home within 15 minutes. Experts say they could be a 'game-changer' in helping people find out quickly if they need to isolate. NPR.org

The U.S. Food and Drug Administration on Tuesday authorized the first coronavirus test that people will be able to buy at a local store without a prescription and use for immediate results at home to find out if they're positive or negative.

The test will cost about $30 and be available by January, according to the Australian company that makes it, Ellume.

The FDA had previously authorized other tests that let people avoid long lines by collecting a sample themselves at home. But those tests require people to send the sample to a lab and wait for the results. Another recently authorized test doesn't have to be sent off to a lab, but it requires a prescription to get it.

The new test is the first that people will be able to buy without a prescription at a local store and do entirely at home on their own. It takes about five minutes to collect the sample and produces results within 15 minutes.

"Today's authorization is a major milestone in diagnostic testing for COVID-19," FDA Commissioner Stephen Hahn said in a statement announcing the authorization.

The test kit includes a special swab that enables users to collect a sample from just inside their nose. Because it can be used on adults and children as young as 2 years old, the swab comes with a special adapter that shortens the length when swabbing youngsters.

Users add a few drops of liquid to the sample and place it into a small plastic device that looks like a home pregnancy test. Results are wirelessly transmitted to a smartphone app within about 15 minutes. ...