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posted by Fnord666 on Monday May 25 2020, @05:47PM   Printer-friendly
from the demonstrate-that-it-works dept.

US begins crackdown on unvetted virus blood tests:

U.S. regulators are moving ahead with a crackdown on scores of antibody tests for the coronavirus that have not yet been shown to work.

The Food and Drug Administration on Thursday published a list of more than two dozen test makers that have failed to file applications to remain on the market or already pulled their products.

The agency said in a statement that it expects the tests "will not be marketed or distributed." It was unclear if any of the companies would face additional penalties.

Most companies faced a deadline earlier this week to file paperwork demonstrating their tests' performance. Regulators required it after previously allowing tests to launch with minimal oversight, which critics said had created a "Wild West" of unregulated testing.

[...] Under pressure to increase testing options, the FDA in March essentially allowed companies to begin selling antibody tests as long as they notified the agency of their plans and provided disclaimers, including that they were not FDA-approved.

The FDA is now working with the National Institutes of Health and other federal health agencies to vet the accuracy of the tests and determine how they can be used to track and contain the virus.


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  • (Score: 2) by All Your Lawn Are Belong To Us on Tuesday May 26 2020, @02:48PM

    by All Your Lawn Are Belong To Us (6553) on Tuesday May 26 2020, @02:48PM (#999221) Journal

    Not quite. You have a point but you haven't accounted for the latent period [wikipedia.org] of the infection. And there is at least one study that suggests the total incubation period [nih.gov] is far shorter, around 5 days and similar to SARS. I suppose one might still be asymptomatic and shedding, though, so maybe out as far as 14 days would be better. But the infectious period might not start until day 4 of those 14.

    But the real error in your thinking is that one (or even several) exceptions mean there should be no rule. Or perhaps you are confused between the differences between individual health and community/population health.

    Public health isn't (generally) about eliminating the disease, because people and most governments will not do what it takes to eliminate it. Rather it is about flattening the curve. Like nobody gets tested and you get 1% of the population infected, do some level of testing and 0.5% of the population gets infected, everybody gets tested regularly and 0.1% of the population gets infected. Is doing some level of haphazard testing worth the 0.5% who won't be infected? Is spending the extra money to get most people tested worth the 0.4% who won't be infected? (My numbers here are hypothetical except that as of today COVID seems to have infected 0.5% of the US population so far. World infection rate is far less.)

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