The U.S. Food and Drug Administration issued Emergency Use Authorization to Illinois-based medical device maker Abbott Labs on Friday for a coronavirus test that delivers positive results in as little as five minutes and negative results in 13 minutes, the company said.
The company expects the tests to be available next week and expects to ramp up manufacturing to deliver 50,000 tests per day.
"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."
Scott Gottlieb, former FDA commissioner, echoed Hahn's comments on Twitter, calling the development a "game changer." Gottlieb also said it's "very likely" that we'll see additional approvals of point-of-care diagnostics behind this one, extending testing to doctor offices across the U.S.
(Score: 4, Informative) by istartedi on Monday March 30 2020, @07:48AM (1 child)
Here's a description of the device [medline.com] and it looks like this is the appropriate wiki for the process [wikipedia.org]. It does indeed appear to be some kind of portable DNA amplification device.
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(Score: 2, Informative) by Anonymous Coward on Monday March 30 2020, @08:40AM
Close, it is actually https://en.wikipedia.org/wiki/Reverse_Transcription_Loop-mediated_Isothermal_Amplification [wikipedia.org] but I didn't cite that in my earlier post that contained the link to the documents on the FDA website because I wanted to see if OP would actually read them or continue bashing "antibody tests."