The FDA approved the first over-the-counter COVID-19 test with a nasal swab on Tuesday – and almost immediate results.
By approving a test for over-the-counter use, the FDA allows it to be sold in places like drugstores, where a patient can buy it, wipe their nose, perform the test, and find their results in just 20 minutes , ” said Stephen Hahn, Commissioner of the Food and Drug Administration, in a statement posted on the agency’s website.
“Today’s approval is an important milestone in the diagnostic testing for COVID-19,” said Hahn.
The agency has already approved more than 25 coronavirus tests in consumers’ homes, but so far the collected samples had to be sent to a lab for results.
The diagnostics company Ellume makes the new complete home test.
There are drawbacks to it, but developing it is still an important step in the diagnosis of the virus, said Jeff Shuren, the FDA’s director of the Center for Devices and Radiological Health.
“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests performed in a laboratory,” Shuren said in the publication. “But the fact that it can be used completely at home and produces results quickly means it could play an important role in response to the pandemic.”