A new coronavirus test device by Abbott Labs has been issued Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).
The test, called ID NOW COVID-19, delivers positive results in as little as five minutes and negative results in 13 minutes, Abbott said.
“I am pleased that the FDA authorized Abbott’s point of care test yesterday,” Steve Hahn, FDA Commissioner said in a statement on Friday.
The test device which is described by the company to have the same size as a toaster will shorten the time of getting the COVID-19 result which currently takes about 24-48 hours in advanced countries like US and Europe.
“We know how important it is to get point of care tests out in the field quickly. These tests that can give results quickly can be a game-changer in diagnosing COVID-19,” Hahn said.
According to the Illinois-based medical device maker, the tests is likely to be available next week and the company expects to ramp up manufacturing to deliver 50,000 of the portable, point-of-care molecular test per day.
“It’s very likely that we’ll see additional approvals of point-of-care diagnostics behind this one,” Scott Gottlieb, former FDA commissioner, commented on Hahn’s tweet while calling Abbott’s device a “game-changer.”