FDA Grants Abbott Emergency Use Approval for Rapid, Portable COVID-19 Test

March 30, 2020

Abbott is ramping up production of the new test that can deliver a positive COVID-19 result in 5 minutes.

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 5 minutes, and doesn't need a lab to produce results, according to an Abbott news release.

Another unique aspect of the test, called the Abbott ID NOW COVID-19 test, is that it can be used in a physician's practice setting or urgent care clinic, the news release said. According to the company, the positive test can be determined in as little as 5 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.

The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster) and uses molecular technology, prized for its high degree of accuracy.

"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.

 

For more COVID-19 coverage for primary care, visit our COVID-19 Resource Page.

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