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Medicine United States

America Authorizes Its First Covid-19 Diagnostic Tests Using At-Home Collection of Saliva (cnn.com) 65

An anonymous reader quotes CNN: The U.S. Food and Drug Administration on Friday issued an emergency use authorization for the first at-home Covid-19 test that uses saliva samples, the agency said in a news release. Rutgers University's RUCDR Infinite Biologics lab received an amended emergency authorization late Thursday. With the test, people can collect their own saliva at home and send their saliva samples to a lab for results...

"Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor's office, hospital or testing site," FDA Commissioner Dr. Stephen M. Hahn said in the FDA's press release on Friday...

The test remains prescription only.

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America Authorizes Its First Covid-19 Diagnostic Tests Using At-Home Collection of Saliva

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  • by AndyKron ( 937105 ) on Friday May 08, 2020 @11:51PM (#60039644)
    By the time you got the kit, sent it back and got the results you'd either be recovered or dead
    • Or you will have never had it. Or you will have contracted it after taking the test.
    • >"By the time you got the kit, sent it back and got the results you'd either be recovered or dead"

      I agree this product isn't very useful for most any case I can think of. If you have no symptoms, there is no point (and why would it be prescribed?) If you are sick, then you are sick- knowing if it is COVID-19 changes pretty much nothing, you should still ASSUME it is COVID-19 and take precautions to prevent spread (like you had been doing before, right?) If you test positive, it doesn't change being si

  • by Opportunist ( 166417 ) on Saturday May 09, 2020 @02:18AM (#60039836)

    Let's for a moment dissect what we're looking at here. This ain't no home preg test, ok? It's not "piss (or spit) on this, wait 5 minutes and cry yourself to sleep when it turns blue". You're supposed to drool on it, hope that the preservation fluid properly mixes with it, hope that you can put it back into the send back envelope without spilling, hope that your local post office doesn't just throw it away because FFS, why should they be tasked mailing what's essentially a potential health hazard especially since it has BIOHAZARD printed all over it like it's the latest installment of Resident Evil, hope that the sample is still in a testable condition when it arrives, hope that you didn't fuck up in the process and then...

    Do I have to go on or does this have "false positive/negative" already written all over it enough for your tastes?

    Good, because that's what we're heading for. This is about as reliable as the average magical 8 ball, and I'm not even questioning that they did what they could but they certainly did not take into account what I lovingly dubbed the "bigger idiot theory" of test kit design: That is, if you make a test kit with instructions that the average trained healthcare professional can follow even if he's been drunk or working for 48 hours or presumably both, the average trained healthcare professional will fuck it up at least one out of 10 times, if they have experience with the kit and got some training.

    Now let's imagine the average layman without any training and you can with some credibility expect better results when you're having a bunch of bi-polar asthmatics do the mountain etappe of the Tour de France.

    There will be false negatives up the ass. Why negatives you ask? Because false positives are fortunately at least with this test near impossible, but with this amount of variables it's almost ensured that people will not be able to deliver a sensible sample. And that's assuming that they are actually following procedures and not try to be clever, e.g. by having the whole family spit into the testing funnel because it's cheaper to get all of us tested in one go.

    • by thegarbz ( 1787294 ) on Saturday May 09, 2020 @07:32AM (#60040154)

      hope that your local post office doesn't just throw it away because FFS, why should they be tasked mailing what's essentially a potential health hazard especially since it has BIOHAZARD printed all over it

      All right, calm down, take a breath. The post office is actually staffed by people who not only know what they are doing, but also don't get a kick out of committing federal felony offences on a daily basis.

      • I didn't mean they would break the law, but I do know that at the very least since the Anthrax scare of post-9/11 there's at least in my jurisdiction no longer a requirement to transport anything that is likely to contain material that may endanger the health of postal workers.

        I'd guess we see this being used to challenge transportation of those samples.

    • Millions of people have already done the exact same thing for DNA testing, with decent enough success rate that the companies keep making a profit. Many of my friends have done it and I haven't heard of a sample being rejected. It's not hard. Certainly easier than doing the swab test by yourself.

      Now, in the case of this virus the test will likely miss some infections (say, if the virus is primarily in the GI tract) but presence in the saliva is a fairly good proxy for presence in exhaled air, which is the p

      • DNA testing is a fundamentally different beast. First, getting a valid sample is heaps easier because pretty much any body fluid of yours contains sufficient quantities of DNA to pretty much ensure you can't mess this up, there's a reason why even police personnel usually manage to get a sensible sample. And, let's face it, for civilian purposes, unless you're charcoal black and the results come back with your ancestry being half from Ireland and half from Sweden, how would you even know that it was unusabl

    • Isn't this the same method people use to do ancestry type DNA testing? It seems to work well enough for that.

  • So I'm going to hold out for one of those tests.
  • Thought it said diagnostic test using salvia. Now there is a test we could finally pass on here.

  • It's totally useless, every single comment posted is more-or-less trolling and nonsense, it's a waste of bandwidth, just delete the whole mess.

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