FDA grants emergency use approval to Abbott's fast, portable COVID-19 test

March 28, 2020
Chris Mazzolini

Chris Mazzolini is the editorial director of Medical Economics

The test can detect positive results in as little as five minutes, and can be used in a physician's practice, according to an Abbott news release.

Abbott has received emergency use authorization (EAU) from the FDA for a molecular test that can determine a positive COVID-19 case in as little as five minutes, and doesn't need a lab to produce results, according to an Abbott news release.

Besides the speed of results, the other unique aspect of the company's new test, called the Abbott ID NOW COVID-19 test, is that it can be used in a physician's practice or urgent care clinic, the news release said. According to the company, the positive test can be determined in as little as five minutes, and a negative test in 13 minutes.

The company says it is ramping up production of the test and plans to start delivering 50,000 tests per day beginning next week. Combined with another test the company produces for lab environments, Abbott officials say they will produce about 5 million tests in April.

"Portable molecular testing expands the country's capacity to get people answers faster," said Chris Scroggins, senior vice president for rapid diagnostics for Abbott, in a news release.

According to the FDA, more than 220 test developers have are working with the FDA to submit EAUs for tests that detect the coronavirus. To date, 19 EAUs have been issued for diagnostic tests. Additionally, the FDA has been notified that more than 110 laboratories have begun testing under existing FDA policies guidance.