The FDA on Tuesday approved the first over-the-counter test for COVID-19 involving a nasal swab and near-instantaneous results.
“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like pharmacies, where a patient can buy it, whip their nose, do the test, and find out their results in as little as 20 minutes.” , said Stephen Hahn, commissioner of the Food and Drug Administration, in a statement on the agency’s website.
“Today’s authorization is an important milestone in COVID-19 diagnostic testing,” Hahn said.
The agency has already approved more than 25 coronavirus tests at home, but so far the samples collected had to be sent to a lab for results.
Diagnostic company Ellume does the new test completely at home.
There are drawbacks, but their development remains an important step in the diagnosis of the virus, said Jeff Shuren, director of the FDA’s Center for Radiological Devices and Health.
“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests that are done in a laboratory,” Shuren said in the statement. “However, the fact that it can be used completely at home and get results quickly means it can play an important role in response to the pandemic.”