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Biotech Medicine United States

America's FDA Grants Emergency Approval for a 15-Minute Coronavirus Test (nbcnews.com) 88

Posted by EditorDavid from the passing-a-test dept.
While many coronavirus tests provide results within hours or days, America's Food and Drug Administration "has authorized the emergency use" of a new rapid coronavirus test from medical device manufacturer Abbott that could results in less than 15 minutes, reports NBC News: The FDA told Abbott it authorized the test's use after determining that "it is reasonable to believe that your product may be effective in diagnosing COVID-19," based on the scientific evidence presented. The agency added that the "known and potential benefits" of the test outweigh potential risks, such as false positives or negatives. The technology being used for the new test is similar to the one found in rapid flu tests, according to the FDA's authorization letter and Abbott.

The FDA also said Friday it has issued at least 19 other emergency use authorizations for diagnostic tests to detect COVID-19, and that it is working with more than 220 test developers who are expected to submit emergency-use authorization requests soon...

Abbott said it is ramping up production to deliver 50,000 tests to the U.S. health care system starting next week.
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America's FDA Grants Emergency Approval for a 15-Minute Coronavirus Test More

America's FDA Grants Emergency Approval for a 15-Minute Coronavirus Test

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  • The agency added that the "known and potential benefits" of the test outweigh potential risks, such as false positives or negatives.

    If both false positives and negatives are acceptable, you may as well use my test, which will give the results in less than a minute. And it is only $19.99, including shipping and handling.

    Call now, operators are standing by!

    • Re: (Score:2)

      by DRJlaw ( 946416 )

      Please present your predictions and actual results in link-pairs, or they will be returned unread.

    • Re:My test has results in 1 minute! (Score:5, Insightful)

      by hey! ( 33014 ) on Saturday March 28, 2020 @01:15PM (#59882322) Homepage Journal

      Actually a rapid screening test with a moderately high false positive rate would actually be useful. Let's say 25% of your results were positive, and 80% of those positive results were false. You'd still have to use the existing test to confirm, but you conserve 75% of your precious reliable tests.

      The real danger is false negatives. Relying on a test with even moderate false negative results could accelerate the community transmission of the virus.

      • Actually a rapid screening test with a moderately high false positive rate would actually be useful.

        Hmm, lets use your 25% false positive rate...

        Imagine we have 3 million people with Covid-19. And 330 million without.

        So, the 3M people with the disease are shown as having the disease. As well as 82.5M who don't have the disease....

        Frankly, losing the actual victims of the disease in a sea of false positives (27 false positives for every actual positive) seems like a great way to waste enormous effort to

        • Actually a rapid screening test with a moderately high false positive rate would actually be useful.

          Hmm, lets use your 25% false positive rate...

          Imagine we have 3 million people with Covid-19. And 330 million without.

          So, the 3M people with the disease are shown as having the disease. As well as 82.5M who don't have the disease....

          Frankly, losing the actual victims of the disease in a sea of false positives (27 false positives for every actual positive) seems like a great way to waste enormous effort to no real gain....

          You haven't considered the other factors of testing. Speed and Cost for example.

          330 million cheap tests and then 85.8 million expensive tests is cheaper than 330 million expensive tests.

          330 million quick 15 minute tests and let the 244.5 million go back to work while quarantining just the 85.5 million waiting for the slower test.

      • Re: (Score:1)

        by mi ( 197448 )

        A test with only false negatives xor false positives might be useful, yes. But if both inaccuracies are possible, then it is useless...

        • Re: (Score:3)

          by puck01 ( 207782 )

          There no such thing as tests in clinical medicine without false positives and false negatives. There are some that have very low rates. None are perfect.

          • Re: (Score:2)

            by mi ( 197448 )

            Could you elaborate on the usefulness of a test, that can err in both directions?

            Whatever the test's results, you can declare the tested neither healthy nor infected... What good are they, then?

            • If a test has a 2% false Negative rate and a 10% false positive rate but is otherwise fine then you can use it very safely and usefully to trigger quarantine. You will now have 98% of your infected people not infecting people and 90% of your non-infected people will be able to do useful work in the community.

              This is much better than the current situation where we have a "mostly" lockdown where everyone is still at slight risk of infecting others (when they go out to shop) but nobody is able to work.

              Thi

              • Re: (Score:2)

                by mi ( 197448 )

                But the 2% you didn't quarantine are still walking around — convinced, they are healthy, infecting the rest of the uninfected population... They are happy go get back to work, infecting coworkers, and shop, travel, visit loved ones in nursing homes (as well as and attend concerts and parties, if there are any). Because, hey, they got tested — and it came out negative.

                I can't tell, off hand, if that's "better than the current situation" — and Abbott's test may well have much higher than 2%

                • But the 2% you didn't quarantine are still walking around — convinced, they are healthy, infecting the rest of the uninfected population...

                  You are kind of right, however if they do infect someone then that should detected pretty quickly since you should be testing everyone. Also you have to give them instructions to be careful until they have at least one more test that comes out negtative.

                  They are happy go get back to work, infecting coworkers, and shop, travel, visit loved ones in nursing homes (as well as and attend concerts and parties, if there are any). Because, hey, they got tested — and it came out negative.

                  I can't tell, off hand, if that's "better than the current situation" — and Abbott's test may well have much higher than 2% rate of false negatives...

                  You will still have to run social isolation for e.g. nursing homes for quite a while until the general population infection rate falls to almost zero. This situation will be better than total lock down for the simple reason that it can be sustained indefin

                  • Re: (Score:2)

                    by mi ( 197448 )

                    Also you have to give them instructions to be careful ... You will still have to run social isolation

                    What good is the test then? We're doing those things already, and we still wouldn't be able to exempt anyone from these measures no matter what the test says...

                    until they have at least one more test that comes out negative.

                    Which test will that be? And, if you have to administer another test — presumably, one more expensive/complicated — to all those, who tested negative, why not start with it?

                    The

            • Re: (Score:2)

              by puck01 ( 207782 )

              The practice of medicine is all about collecting information, placing it in the right context and using good judgement. Tests used without any context can be more harmful than good for many reasons. One is because there is no such thing as a perfect test.

              Things like a thorough history and exam are where things should start. A good clinician will have a working probability of what the different possible problems are and the tests that in that situation that will be helpful to rule in or rule out workin

          • There are tests with good specificity and with good sensitivity. The main thing which bothers me is that people start talking about 'this is a bad test' without looking at the specifications. AFAIK antibody tests are fast but they are best used to find out if you have been ill, not whether you are ill.

        • Re: (Score:2)

          by hey! ( 33014 )

          Well, both are always possible.

        • Re: (Score:2)

          by hey! ( 33014 )

          I should add that most doctors, unfortunately, aren't really very good at the statistics end of things -- e.g. recognizing the base rate fallacy. At least in my opinion. What they do have is clinical experience, which is a gut level Bayesian calculation.

          The thing about gut feelings is that their reliability depends pretty strongly on how experienced your gut is with a situation. I'd trust the gut of someone with twenty years of family medicine practice over some Internet rando. Now epidemiologists and

      • Re: (Score:1)

        by AHuxley ( 892839 )
        That is why advanced nations test their tests before use and test their masks.
        No just accepting tests without a lot of testing.
  • Comment removed based on user account deletion

  • Theranos would have ruled this space. /s

  • ... another factor that will distort the counts, both via tests done and via false positives/negatives.

    Keep that in mind, when seeing a large rise in the time after.

    Especially when the media predictably fearmongers the shit out of it. (On top of the realistic fears.)

  • Critics of private sector involvement in medicine should be content with taking one of the government lab tests and waiting 3 or 4 days for results.

    Abbott labs makes profits and they're critical of that. Shouldn't we all help these people avoid compromising their principles?

  • Comment removed (Score:5, Interesting)

    by account_deleted ( 4530225 ) on Saturday March 28, 2020 @01:23PM (#59882338)
    Comment removed based on user account deletion

    • Greets.

      The new Rapid Test for Covid-19 by Abbott Labs was developed with R & D in San Diego, California and Scarborough, Maine. It is NOT an Antigen test and was NOT developed in Belgium.

      Since I logged in, I can't declare anything else but consider this authoritative.

      • Re: (Score:2)

        by DrJimbo ( 594231 )

        According to this how it works video [youtube.com] from Abbott labs this is indeed an antigen test, not an antibody test. The video explains that a chemical solution cracks open the virus exposing the RNA then the machine replicates a portion of the RNA thus making it detectable.

        As you said, this is not the new 15 minute test from Belgium [brusselstimes.com]. That test is also an antigen test but has low sensitivity. The test from Belgium comes in the form of blotting paper [www.rtbf.be] like a pregnancy test. This is very different from the A

        • It's a molecular test. It detects virus RNA by taking swabs from the nose or back of throat and sticking them in the reagent part of the machine with rapid amplification.

          An antibody test would be serological and by definition require a blood draw. The id now system doesn't handle blood.

  • The test looks interesting, but it's not clear what the rates of false positives and false negatives are. In fact they don't mention even what kind of errors will be expected.

    FWIW, I expect it's an antigen test that is likely to miss the early infectious period and to continue reporting presence of the disease after the immune system has cleared active viruses (unless those reports from China mean that active viruses are only being temporarily suppressed). But even after looking at the articles this is a guess.

    • The test looks interesting, but it's not clear what the rates of false positives and false negatives are. In fact they don't mention even what kind of errors will be expected.

      Actually, they do, assuming that houghi is correct that this is a Belgian-developed test [slashdot.org]. Their claim is that the false positive rate is low, while the false negative rate is high:

      "Leading virologist Marc Van Ranst commented on the test: âoeThe new antigen test will certainly speed up diagnostics in hospitals, because in fifteen

      • So we might say a few people aren't infected are actually infected, but we'll say a lot of people who are infected are not. That's about the worst thing you can do - occupy beds/treatment for those who don't need it but more importantly let lots of sick continue walking around...

        • Ha, you won't get treatment merely because you're infected, you'll be told to go home and stay their, and not call for help unless you're dying.

      • Re: (Score:2)

        by HiThere ( 15173 )

        Well, for me the FDA link returned a blank page, and for the other links I only followed them down one level. On those I didn't see anything about error rates, even on rechecking them. I'm not sure one can assume that it's the same test as the one another company announced, but it may be.

        The links that I saw didn't even assert that it was an antigen test. I expect it is, but that's my expectation, not something that Abbot Labs is claiming (on the directly linked pages).

        Still, the error rates you asserted

    • https://fda.gov/media/136525/d... [fda.gov] The clinical study is at the bottom with 100% identity of expected results. If the virus mutates, tests will be off. Lots of gotchas as you would expect around a EUA.

  • This might be why we are seeing reinfections... People that tested positive may not have it... and when they test positive again... they still may not even have it...

    Hmm... not sure if we should be using this test since it is at risk of over or under reporting proper results. I would like to know just like everyone else if they have this stuff when they get the sniffles but if we are not accurate enough... then there is no point to testing at all.

  • Bioscience is making progress (Score:4, Interesting)

    by ellbee ( 93668 ) on Saturday March 28, 2020 @02:38PM (#59882482)

    Between RNA molecular tests like this that detect active virus and progress in blood tests that detect antibodies in people that have acquired immunity we will be able to get a handle on infection rates and progress towards herd immunity. This is a more likely outcome than waiting for a possible vaccine in the summer/fall of 2021.

    On Thursday the FDA allowed use of more than two dozen blood tests - that aren't all fully tested and there are many caveats, but they should become inexpensive and universal. The tests that work well will come to the fore and will quickly dominate the market.

    The FDA list (under 'serology tests') is at:
    https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2

  • Just like those 15-minutes exercise routines ... (Score:3)

    by fahrbot-bot ( 874524 ) on Saturday March 28, 2020 @03:23PM (#59882588)

    I'll wait for the 14-minute test to come out.

  • What if someone comes up with a video for 5 minute abs?
    https://www.abbott.com/corpnew... [abbott.com]

  • Is this Trump and his crew putting their fingers in stupid places??? "Just find ways to do more tests -- They don't have to be accurate I just want NUMBERS! ". It kinda sounds like Trump, doesn't it?

    Like somebody else said: I'm fine with false positives, but false negatives could have misdiagnosed carriers wandering the city infecting people. It'll look good for Trump until,, 3 weeks down the road, you've got a thousand more victims cascaded from the one false negative.

    We really do need to see some

  • I am waiving the following requirements for your product during the duration of this EUA:

    • Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of your product.

    From the authorization letter [fda.gov]

    yep.. Sounds like Trump. You can make a lot more tests if you don't have to worry about the quality

  • This new testing tool will help test all the people and detect the cases to keep them away from others like South Korea did. Early detection and self isolation is the most important thing to restrict transmission of Coronavirus

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