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Medicine United States News

FDA Cautions About Accuracy Of Widely Used Abbott Coronavirus Test (npr.org) 26

The Food and Drug Administration is cautioning the public about the reliability of a widely used rapid test for the coronavirus. The test, made by Abbott Laboratories, has been linked with inaccurate results that could falsely reassure patients that they are not infected with the virus. From a report: The Trump administration has promoted the test as a key factor in controlling the epidemic in the U.S., and it's used for daily testing at the White House. As first reported on NPR, as many as 15 to 20 out of every 100 tests may produce falsely negative results. A study released this week indicated that the test could be missing as many as 48% of infections. The FDA issued the alert on the Abbott test "in the spirit of transparency." In a press release, the agency said it's investigating whether the false-negative results could be connected to the type of swab used in the test or the material the samples are stored in for transport. It also cautions that "any negative test results that are not consistent with a patient's clinical signs and symptoms or necessary for patient management should be confirmed with another test."
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FDA Cautions About Accuracy Of Widely Used Abbott Coronavirus Test

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  • Good (Score:4, Funny)

    by nospam007 ( 722110 ) * on Friday May 15, 2020 @03:50PM (#60065172)

    "The Trump administration has promoted the test as a key factor in controlling the epidemic in the U.S., and it's used for daily testing at the White House"

    Good to hear.

    • It is almost as if they are trying to give people false assurances

    • Re: Good (Score:3, Insightful)

      by saloomy ( 2817221 )
      This is Trumps fault? He purposefully implemented a bug in the test I presume? Every bit of bad news is the fault of the administration, and all good news is credited to anyone but Trump. It's getting old. He used it in TWH so it must have been believed to be a valid test. Credit to them for issuing the warning in the issue of transparency. Also, this bodes well for the argument that it's more widespread (and therefore less deadly) than we originally thought, by a lot.
      • I believe they did change the rules to allow the tests to be used before they were verified (in)accurate.

        • Re: Good (Score:5, Insightful)

          by jbengt ( 874751 ) on Friday May 15, 2020 @04:57PM (#60065414)

          This is Trumps fault? He purposefully implemented a bug in the test I presume?

          I believe they did change the rules to allow the tests to be used before they were verified (in)accurate

          Trump didn't make the test faulty, nobody's blaming Trump for that. And, of course, Abbott claims the test isn't faulty, the testers were just holding it wrong - though these kinds of tests are very sensitive, so it's easy to get wrong. And you can't necessarily blame people for relaxing the rules a little in an attempt to get things done in the middle of a crisis - if there's no other way to do it, anyway.
          However, you can blame the Trump administration for touting it under these circumstances as a silver bullet for testing.

          • Re: (Score:3, Insightful)

            Yup. Trump signed up for his share of blame for the problems. That is on him. Nobody forced him to. He just saw an opportunity to grab a small uptick in his poll numbers and grabbed it with both hands.

          • However, you can blame the Trump administration for touting it under these circumstances as a silver bullet for testing.

            How on earth does he keep doing this? "Our problems are over, because:
            Our problems don't exist.
            Our problems will go away on their own.
            I've got some snake oil.
            Hey, maybe snake venom would work. It would be interesting to check that.
            I've got some different snake oil."

            My dog only has to make a mistake once before he learns not to do it again.

      • by DRJlaw ( 946416 )

        This is Trumps fault? ... Every bit of bad news is the fault of the administration, and all good news is credited to anyone but Trump. It's getting old.

        "The buck stops anywhere but here. Because you don't appreciate me enough."

  • The government not being useful at any point.

    So the FDA basically says if you get a negative then try again. Iâ(TM)m sorry we couldnâ(TM)t spend a few years on developing these tests. I know, it is a real hardship you operate out of your comfort zone. People are a little worried, but fuck em. In either worst case scenario we either die from the disease or starvation. Probably not a worry for a cushy government job.

    • So the FDA basically says if you get a negative then try again.

      Actually, they're saying if you show symptoms but your test is negative, you should confirm that test (likely with a different method, but the wording is unclear) because the odds are not in favor of two false negatives. Regardless, if you feel sick you should stay at home until you don't, because that's how sane people are supposed to act regardless of COVID19.

      This is the quick test, mind you. Most people are being tested with a different te

      • by ghoul ( 157158 )

        The test has a manual step where the technician has to mix the swab and the chemical. if they mess it up the test wont work. So if you really expect someone to be positive clinically but the test comes back negative you should redo the test. As the technicians get better at administering the test the rate of false negatives should go down. Or we might move over to a a more accurate but slower test like the Codiagnostics test (this was actually the first test to get FDA EUA but it takes 45 minutes while the

        • by ghoul ( 157158 )

          As a plus point the CODX test is done on saliva so it doesnt need a nasal swab which are in short supply.

        • Man, I think if I were Trump (old, overweight, possibly diabetic) I'd have staff administer the CODX test. I doubt he cares if people would have to wait 45 minutes before seeing him instead of 5.
    • by HiThere ( 15173 )

      This really isn't new information. The problem is that people started over-trusting the results, so the FDA is warning them not to. IIRC there's a 30% false negative reading. This is great for doing population statistics, and diagnostically useful if you can test each person a few times. And it has a much lower false positive result, so if it says you've got COVID, you can pretty much trust it.

      Yes, it's a useful test, if used appropriately. It sure isn't the be-all end-all, though.

  • Just cut them off, we have better tests than that.

    • Just cut them off, we have better tests than that.

      Yeah, but not nearly enough. China is doing more tests in Wuhan this week than the US has done to date. The entire US for the entire pandemic. One Chinese city.

      Domestic manufacturing capacity is woefully inadequate.

  • Our dear leader says he's not concerned about the test [marketwatch.com], that it's a great test.

    That's all we need to know. No need to pursue any investigation or perform studies on the accuracy of the test. The con artist has spoken.

  • or toss a coin to get a test?

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