FDA Gives Abbott Emergency Use of Five-Minute Coronavirus Test
FDA Gives Abbott Emergency Use of Five-Minute Coronavirus Test

FDA Gives Abbott Emergency Use of Five-Minute Coronavirus Test

The machine can be run in doctor’s offices and other point-of-care settings to give rapid results.

Kerry Grens
Kerry Grens
Mar 30, 2020

ABOVE: ABBOTT

The US Food and Drug Administration has granted emergency use authorization of Abbott’s newest coronavirus test, which can read out positive results within 5 minutes and negative results in 13 minutes. The portable ID NOW machine, which will run the SARS-CoV-2 test, can be used in doctor’s offices, expanding the availability of testing beyond hospital and laboratory settings, and the company aims to produce 50,000 tests daily starting next week.

The FDA has given emergency use authorization (EUA) to other point-of-care coronavirus tests, namely, Cepheid’s 45-minute assay and Mesa Biotech’s 30-minute test. As STAT reported, Cepheid’s test would be applied in urgent situations, say, to help with triaging patients, rather than in doctor’s offices. Mesa’s instrument, like Abbott’s, can be used in doctor’s offices, nursing facilities, and elsewhere.

COVID-19 diagnoses have topped 140,000 in the US and deaths have surpassed 2,400, according to the Centers for Disease Control and Prevention

The US has been slow to ramp up testing, and the FDA has worked to expedite emergency approvals to get more products to healthcare facilities. EUA is a “relaxed standard” that requires fewer data supporting the product, according to a statement from the FDA, and so far the agency has granted 20 coronavirus tests emergency use.

See “Locally Made COVID-19 Tests Help Meet Demands

“We know how important it is to get point-of-care tests out in the field quickly,” FDA Commissioner Steve Hahn says in a statement to USA Today. “These tests that can give results quickly can be a game changer in diagnosing COVID-19.”

The ID NOW instrument has been in use for years to test patients for influenza, strep, and respiratory syncytial virus. A spokesperson for Abbott tells Business Insider the COVID-19 tests will become available April 1. According to US Today, there are roughly 18,000 ID Now devices in use, and it’s not clear whether more instruments will be produced in addition to the SARS-CoV-2 tests.

See “How SARS-CoV-2 Tests Work and What’s Next in COVID-19 Diagnostics