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posted by Fnord666 on Monday March 30 2020, @02:40AM   Printer-friendly
from the faster-testing dept.

'A game changer': FDA authorizes Abbott Labs' portable, 5-minute coronavirus test the size of a toaster:

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.


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  • (Score: 2, Interesting) by Anonymous Coward on Monday March 30 2020, @05:06AM (1 child)

    by Anonymous Coward on Monday March 30 2020, @05:06AM (#977113)

    Antibody titer and complement fixation tests can test for both antibodies and antigens. In addition, there sensitivity/specificity isn't "crap." You can get all sorts of approved tests with high sensitivities and specificities. The reason why most people think they are crap is because they are usually used for fast screening, which are usually designed with a sensitivity as high as possible with type two errors in the fractions of a percent, balanced out with a 90%+ specificity. More specific tests can be done later with minimal additional cost, especially when compared to the cost of missing a true positive for diseases where such fast-screening tests are approved for use.

    But here is the EUA for this particular screening test for anyone interested: https://www.fda.gov/media/136525/download [fda.gov]

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  • (Score: 1, Informative) by Anonymous Coward on Monday March 30 2020, @05:13AM

    by Anonymous Coward on Monday March 30 2020, @05:13AM (#977116)

    That was the Instructions/Insert information. This is the actual EUA: https://www.fda.gov/media/136522/download [fda.gov] but it isn't nearly as interesting.