FDA Approves 'Game Changer' Test for COVID-19. Here's How Quickly Results Come Back.

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Posted: Mar 28, 2020 4:50 PM
FDA Approves 'Game Changer' Test for COVID-19. Here's How Quickly Results Come Back.

Source: Via Abbott

The Food and Drug Administration (FDA) granted emergency approval for a rapid COVID-19 test that delivers results in under 15 minutes. Abbott, the company behind the test, says the test is the "fastest available molecular point-of-care test for novel coronavirus." 

In a press release, the company claims the new test can deliver positive results for COVID-19 in as little as five minutes and negative results in 13 minutes. The test can also be administered outside the traditional hospital setting. The test involves a 6.6-lb box that is similar in size to a small toaster.

"What makes this test so different is where it can be used: outside the four walls of a traditional hospital such as in the physicians' office or urgent care clinics," the press release notes. 

Abbott announced they are now ramping up production of the new tests and expect to deliver 50,000 Wuhan coronavirus tests per day beginning next week. 

"I am pleased that the FDA authorized Abbott's point-of-care test yesterday. This is big news and will help get more of these tests out in the field rapidly," FDA Commissioner Steve Hahn said in a statement. "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."

The test has received only limited authorization amid the Wuhan coronavirus pandemic and has not been officially cleared or approved by the FDA. 

The United States has now performed more Wuhan coronavirus testing than any other country, though mainstream media reports are quick to point out that testing in the United States per capita remains much lower than countries with much smaller populations. But the same media outlets ignore per capita calculations when reporting the total number of confirmed coronavirus cases in order to sensationalize the pandemic in the U.S.

The FDA also granted emergency approval for tests from Cepheid, which provides results in 45 minutes.