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Medicine United States Science

FDA Authorizes 1st Home Coronavirus Test That Doesn't Require A Prescription (npr.org) 61

Posted by msmash from the moving-forward dept.
The U.S. Food and Drug Administration on Tuesday authorized the first coronavirus test that people will be able to buy at a local store without a prescription and use for immediate results at home to find out if they're positive or negative. From a report: The test will cost about $30 and be available by January, according to the Australian company that makes it, Ellume. The FDA had previously authorized other tests that let people avoid long lines by collecting a sample themselves at home. But those tests require people to send the sample to a lab and wait for the results. Another recently authorized test doesn't have to be sent off to a lab, but it requires a prescription to get it.
The new test is the first that people will be able to buy without a prescription at a local store and do entirely at home on their own. It takes about five minutes to collect the sample and produces results within 15 minutes. "Today's authorization is a major milestone in diagnostic testing for COVID-19," FDA Commissioner Stephen Hahn said in a statement announcing the authorization.
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FDA Authorizes 1st Home Coronavirus Test That Doesn't Require A Prescription More

FDA Authorizes 1st Home Coronavirus Test That Doesn't Require A Prescription

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  • Drive-Through - $75/test (Score:4, Informative)

    by CubicleZombie ( 2590497 ) on Tuesday December 15, 2020 @03:03PM (#60834524)

    Stayed in the car. Kids noses swabbed. Results in an hour (negative). Easy.

    There was a "potential exposure" so I had to get them tested before they were allowed back to school.

    School shut down today after only 3 weeks open. Still zero positive cases.

    • Minnesota provides all residents free at-home tests that you mail in for results. Order tests online, they arrive, you jump on a Zoom call and they walk you through it, mail it in and get your results within 48 hours. I've done this several times now and it works easily.

    • An hour. Jeesh that's backwards. I got my result in 4 minutes at my last test. (I get a test weekly for work reasons and the introduction of a test that didn't get sent overnight to a lab was a gamechanger).

  • Re: (Score:1, Insightful)

    by account_deleted ( 4530225 )
    Comment removed based on user account deletion

    • Re: (Score:2)

      by visorg ( 4521201 )
      isFree = isTrue(money, growsOnTrees)
      Even socially progressive fiscally conservative individuals question your assumption.

      • Well, if you don't let the take any profit, and automate everything that can be, the price will likely be ... about three-fiddy.
        Cents. Not dollars.

        But what he means: Why aren't we manufacturing it ourselves, and paying for that collectively? At that above low price. Paid as a general tax. After all, everyone needs it. Eactly what a government is for.
        (Yes, you need others to be healthy too, even if you "ain't got no corona".)

      • Re: (Score:2)

        by khchung ( 462899 )

        When a person doing something benefits the society as a whole more than the cost, it makes sense for the society (through taxes collected by the government) to pay for the cost of that action.

        More people testing for Covid-19 and having the infected quarantined and treated, thus reducing the spread, generally benefits the entire country for more than the $30 the kit cost, so it make more sense to let people test for free. The problem is how to avoid abuse.

        If the US had socialized medicine, then the test kit

    • By free do you mean someone other than you else has to pay for it?

  • Antibody test (Score:3)

    by Arthur, KBE ( 6444066 ) on Tuesday December 15, 2020 @03:07PM (#60834544)
    I'd a like a test to find out if I've already been exposed.

    • Re:Antibody test (Score:5, Interesting)

      by Anonymous Coward on Tuesday December 15, 2020 @03:33PM (#60834690)

      I'd a like a test to find out if I've already been exposed.

      Donate blood (sorry if you can't). My local blood bank has been testing for COVID antibodies since October. So you get a free test and get to help others.

    • So go get an anti-body test. ... Are they not offered in your country? Most western countries offer voluntary anti-body tests if you're willing to pay for it (~$50, though if you're in the USA I'm sure it's $5000).

      But really why do you want to know if you've already had it? We've got plenty of evidence that having had it before doesn't make you immune from getting it again, and we've also got evidence that getting it again is far worse than the first round.

  • Ugh, it's an app-connected test. (Score:4, Informative)

    by fahrbot-bot ( 874524 ) on Tuesday December 15, 2020 @03:08PM (#60834548)

    From TFA:

    Users add a few drops of liquid to the sample and place it into a small plastic device that looks like a home pregnancy test. Results are wirelessly transmitted to a smartphone app within about 15 minutes.

    Great, smartphone app required. Even if I didn't have privacy concerns, probably won't work on older phones like mine.

    • Re:Ugh, it's an app-connected test. (Score:5, Informative)

      by fahrbot-bot ( 874524 ) on Tuesday December 15, 2020 @03:19PM (#60834610)

      From TFA:

      Users add a few drops of liquid to the sample and place it into a small plastic device that looks like a home pregnancy test. Results are wirelessly transmitted to a smartphone app within about 15 minutes.

      Great, smartphone app required. Even if I didn't have privacy concerns, probably won't work on older phones like mine.

      And from page 3 of the FDA letter [fda.gov]:

      Test results from your product will be automatically reported to relevant public health authorities, via your product’s software application (app), in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the “Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests” provided by the Centers for Disease Control and Prevention (CDC).

      So, have fun with that.

      • Re:Ugh, it's an app-connected test. (Score:4)

        by rogoshen1 ( 2922505 ) on Tuesday December 15, 2020 @03:33PM (#60834688)

        yeah hard pass.

        the privacy aspect was about the only compelling reason to do this test vs one at a clinic.

      • Test results from your product will be automatically reported to relevant public health authorities, via your productâ(TM)s software application (app)

        What prevents you from filling in the form for the app with a fake name and address... apps have no way to inherently know who you are without further input.

      • What a bunch of assholes.

        At least be upfront about it!
        i have no problem telling the docs my test was positive so please make a real test while I go into quarantine.
        But I DO have a problem with this bullshit fuckery!

      • Given that this is, "in accordance with local, state, and federal requirements," it doesn't seem that this is any different from getting a test in person by any other means. I doubt those requirements apply only to the app-based test.

        The real privacy concern with the app (or any app) is: who else gets access to the data, besides the people you know about. (The relevant public health authorities, in this case.)

    • Re: (Score:2)

      by dmt0 ( 1295725 )

      Well that will work great in the future when testing will be required for you to take a flight or go pretty much anywhere.
      1. By a home test
      2. Put it in you rectum
      3. Test negative
      4. Get results automatically uploaded
      5. ???
      6. Profit!

    • I noted below that in this case you won't be doing this test, but anyway, for a hypothetical case where you'd really want to run such an app, why not run it in a virtual machine? It's not like Google doesn't make all required software available to do just that...

  • I don't know if your health workers get them but staff in the UK NHS do.

    Yes they look like pregnancy tests but, like pregnancy tests, they do not need an app. That will be there either to make it more sales staff friendly (by raising the price) or just to help "them" to keep an eye on you.

    I am expected to do one of these twice a week. It's very easy and the testing takes perhaps 5 minutes to do and then 30 minutes to wait for the thing to show a line or two reminiscent of that stick that someone had to w

  • Tests should be heavily subsidized (Score:4, Interesting)

    by jenningsthecat ( 1525947 ) on Tuesday December 15, 2020 @03:58PM (#60834802)

    I think these tests should be basically free to all who want them, and the government should consider it an investment in the country's future, as well as the world's future. In an interview with CBC's Quirks and Quarks [www.cbc.ca], Dr. Michael Mina "said the best real world example of how rapid antigen testing could work is Slovakia, which until very recently was experiencing a severe outbreak. The country tested about a half to two thirds of the population with rapid antigen tests once a week for a couple of weeks, 'and very quickly, they saw the amount of virus in the population dropped by about 50 per cent in just a week or two.' Given the heavy economic and mental toll the pandemic is having on people, Mina said countries like the United States and Canada could benefit strongly by deploying rapid antigen tests in communities where the virus is currently out of control."

    Oddly enough, in TFA Dr. Mina seems to contradict what he said on CBC, saying that "from the perspective of truly stopping or massively slowing this pandemic, this test isn't designed for that". My guess is that he's talking about the (stupidly high) cost of the tests as a barrier to widespread adoption, but I wish he'd been clearer in his comments. But the case for quick, readily available testing seems awfully strong, and our governments are foolish not to be rolling it out as widely as possible, at a low enough cost for the vast majority of people to be able to test themselves frequently.

    • You didn't read the fine print.

      It's a trap to publish your health status to a badly secured database for profit. Can't see the result without the appitty app app.

      • Thanks for the heads-up - I had totally missed that point. So it seems whoever is promoting these things is more interested in data mining and invading privacy than in halting the pandemic. And that device that transmits results to a smartphone explains why the cost is so high. The folks who decided to buy this are evil bastards looking to victimize suckers, and the company that created it is equally evil for having a business model predicated on bastards and suckers.

  • What's the rate of false positives and false negatives?

    • Re: (Score:2)

      by marcle ( 1575627 )

      Plenty of both. Not as accurate as a PCR test.
      So people who don't have COVID will be quarantining, and people with COVID will be merrily out and about spreading it.
      It's not clear to me if this will be any use at all.

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