FDA authorizes two rapid, at-home COVID-19 tests in major move

The Food and Drug Administration (FDA) late Wednesday authorized rapid tests from two companies in a major step forward for the availability of at-home COVID-19 testing.

The authorizations of the Quidel QuickVue and Abbott BinaxNOW tests will allow people to swab themselves at home and get results in minutes. The Quidel test delivers results in 10 minutes and the Abbott test requires 15 minutes.

While the FDA has previously taken some steps toward authorizing at-home tests, advocates hailed the new authorizations as a major breakthrough because the tests are simple, do not require a prescription and can be mass-produced by two major companies to be widely available.

An Abbott spokesperson said the company has the ability to make “tens of millions per month.”

“Abbott will begin shipping to major food, drug and mass merchandiser retailers in the coming weeks,” the company said.

Michael Mina, a Harvard expert who has been pushing the FDA for months to do more to authorize simple, rapid tests, hailed the announcement on Twitter as “BIG NEWS!!”

“Simple, streamlined rapid tests will be available in US,” he wrote.

“We’ve now accomplished what we set out to do when we launched BinaxNOW, which is to bring an accurate, affordable and readily available test to the American people that they can have on hand, whether they want to test frequently or in certain circumstances,” said Robert Ford, Abbott’s CEO. “Together with vaccines, the BinaxNOW Self Test will help Americans get back to doing what they want and need to do – like going to work and school or seeing friends and family – with greater confidence.”

The FDA also reassured the public about the accuracy of the tests, which are designed to be used twice over two or three days to increase their success rates.

“The public can be assured these tests have met our scientific standards for emergency use authorization,” said Jeff Shuren, a top FDA official overseeing testing. “As we’ve said all along, if it’s a good test, we’ll authorize it.”