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Medicine Science

FDA Approves $5 Rapid Coronavirus Test That Doesn't Require Special Computer (cbsnews.com) 55

Posted by msmash from the moving-forward dept.
schwit1 writes: The Food and Drug Administration on Wednesday authorized the first rapid coronavirus test that doesn't need any special computer equipment to get results. The 15-minute test from Abbott Laboratories will sell for $5, giving it a competitive edge over similar tests that need to be popped into a small machine. The self-contained test is the size of a credit card and is based on the same technology used to test for the flu, strep throat and other infections. It's the latest cheaper, simpler test to hit the U.S. market, providing new options to expand testing as schools and businesses struggle to reopen and flu season approaches. The FDA also recently greenlighted a saliva test from Yale University that bypasses some of the supplies that have led to testing bottlenecks. Both tests have limitations and neither can be done at home. Several companies are developing rapid, at-home tests, but none have yet won approval. Abbott's new test still requires a nasal swab by a health worker, like most older coronavirus tests. The Yale saliva test eliminates the need for a swab, but can only be run at high-grade laboratories. And in general, rapid tests like Abbott's are less accurate than lab-developed tests.
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FDA Approves $5 Rapid Coronavirus Test That Doesn't Require Special Computer More

FDA Approves $5 Rapid Coronavirus Test That Doesn't Require Special Computer

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  • "Approved" or "Authorized" (Score:5, Informative)

    by BeerFartMoron ( 624900 ) on Thursday August 27, 2020 @03:07PM (#60447530)

    Simply because I see the two confused so much in the media and really want to drunkenly yell at the world right now.

    FDA Approval: FDA approval [fda.gov] of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. Although many of the FDA’s risk-benefit assessments and decisions are straightforward, sometimes the benefits and risks are uncertain and may be difficult to interpret or predict. The agency and the drug maker may reach different conclusions after analyzing the same data, or there may be differences of opinion among members of the FDA’s review team. As a science-led organization, FDA uses the best scientific and technological information available to make decisions through a deliberative process.

    FDA Emergency Authorization: The Emergency Use Authorization (EUA) authority [fda.gov] allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

    Thank you.

    • As a science-led organization

      Sadly their reputation as such an organization has taken a big hit as of late as Dump has forced them to expand authorization for plasma based on the FDA director elementary school level math

  • Columbia Sorrento Test (Score:5, Interesting)

    by ghoul ( 157158 ) on Thursday August 27, 2020 @03:09PM (#60447534)

    Sorrento has licensed a test which Columbia University developed which needs no machine, uses saliva (no swab) and can be done at point of testing using a heat block (It just needs one warm temperature unlike other tests which need different temperatures hence a more complicated machine). It takes 30 minutes and if its yellow its positive and if its red its negative. The Columbia fertility clinic basically took a pregnancy test and modified it to test for SARS COV2. its gone through trials and found highly accurate - it caught every case the Abbott PCR test caught. It also had no false positives while the Abbott PCR had one false positive.
    Sorrento is working on getting this to production. Once this gets to production we should be able to test without needing a nurse. Only Isue it costs 60 dollars a test. Sorrento is working on getting it down in price. Maybe some Operation Warp Speed or RADx funds will help.

    • Re:Columbia Sorrento Test (Score:4, Informative)

      by ghoul ( 157158 ) on Thursday August 27, 2020 @03:16PM (#60447560)

      To add more details what the test does is DNA transcription in the micro test tube which has all the reagants already in it so add spit and heat it. The test is so sensitive it will will detect even if there are only 2 virrus particles per ml. The positive is that since it is so sensitve you dont need a nasal swab. The negative is that it needs to amplify the virus particles from saliva and that takes 30 minutes.

      Lets see if people are willing to wait 30 minutes with a saliva test or would rather take a swab up their nose for a 5 minute test.

      • Re: (Score:2)

        by HiThere ( 15173 )

        If the accuracy is the same, I'd usually be willing to wait 30 minutes. I can generally find something else to do while waiting. (OTOH, if it's invalid if you wait over an hour, I might need to revise that.)

        • It probably will.
          The HIV rapid tests work the same way, only the waiting time is shorter (15 minutes or so).

    • Sorrento has licensed a test which Columbia University developed which needs no machine, uses saliva (no swab) and can be done at point of testing using a heat block (It just needs one warm temperature unlike other tests which need different temperatures hence a more complicated machine). It takes 30 minutes and if its yellow its positive and if its red its negative. The Columbia fertility clinic basically took a pregnancy test and modified it to test for SARS COV2. its gone through trials and found highly accurate - it caught every case the Abbott PCR test caught. It also had no false positives while the Abbott PCR had one false positive.
      Sorrento is working on getting this to production. Once this gets to production we should be able to test without needing a nurse. Only Isue it costs 60 dollars a test. Sorrento is working on getting it down in price. Maybe some Operation Warp Speed or RADx funds will help.

      What if it's orange? Accuracy is key, this new test is $60, what is the cost of the most currently test in the wild today?

  • This would definitely help slow down the spread. But there is still the issue of people being infectious, but not showing up symptoms yet.

    Without any outside signs (like high temperature), will restaurants require patrons to insert a long swap into their noses every time they visit? Would people be okay getting to cry for every store they go to? (The swabs to really make one's eye water, it is said to be very uncomfortable).

    If we only test the people who has high fever, and let the others in, the test becom

    • Re: (Score:3)

      by ghoul ( 157158 )

      Precisely why we need a working Saliva based test. I would be happy to spit for every shop I enter. I would rather stay home than have a swab up my nose unless its something essential like buying groceries.

    • Perversely enough this might end up being good for indoor malls. Once you take a test to enter a mall you can go to any of 50 differnt stores or entertainment venue whereas stand alone shopping centers you would need a swab for every different shop.

    • Re: (Score:2)

      by mark-t ( 151149 )

      will restaurants require patrons to insert a long swap into their noses every time they visit

      Most restaurants don't have real health workers on staff to administer medical tests.

    • Re: (Score:2)

      by ceoyoyo ( 59147 )

      There's not a lot of point in using testing as some kind of passport. It's not accurate enough; virtually no screening test ever is.

      Screening tests are a public health intervention. They work at the public health level, not at that of the individual.

  • Around here, they make you swab your own nostrils. Having a health worker do it is just more exposure. I don't understand why the FDA says a health worker has to do it for you, It's not difficult.

    • Re: (Score:1)

      by markxz ( 669696 )

      I was tested in the UK (NHS drive-through test) and the swab was taken by the centre staff. They swabbed for longer than I was expecting. I suspect that most people who administer the test themselves would not swab for long enough and would therefore have a higher chance of getting a false negative result.

      The UK testers were are not all fully trained medics, who are needed elsewhere, but from related professions such as opticians (who were closed at the start of the pandemic).

  • end users will be billed $25-$500 per test based what plan. But inmates will pay $0

    • Re: (Score:2)

      by Pascoea ( 968200 )

      No kidding. Clearly the issue with the health care in this country is that we aren't charging our inmates enough for it. We should just charge them $10,000/test and use that money to buy tests for the children. I mean, we have to think of the children, right?

      Inmates are obviously useless pond scum, barely even human anyway. Honestly, I can't figure out why we even bother with keeping them around to begin with. Such a waste of valuable resources. It would be far better if anybody that's charged with an

      • Inmates are obviously useless pond scum, barely even human anyway. Honestly, I can't figure out why we even bother with keeping them around to begin with.

        How dare you!!! Inmates are an essential part of the for-profit incarceration industry. If we did away with the inmates what would be do to preserve our profits - sorry, jobs!! Think about the children - all the children of those working as security, administration, and as lobbyists.

  • Trump went and purchased 150 million units. Company is able to make 50 million per month.

  • Soon to be available from my local hospital for... (Score:5, Insightful)

    by weiserfireman ( 917228 ) on Thursday August 27, 2020 @05:19PM (#60447892) Homepage

    $100 Lab Fee, $250 Facility Fee, $125 Doctor Fee

  • Any information on sensitivity and specificity? Not a fan of Abbott Labs past...

  • One dollar "paper test" that can be performed at home. https://www.youtube.com/watch?... [youtube.com]

    Requiring special equipment vs. being able to do a test at home won't get a lot of test results or usage.

  • What is suspiciously missing is the false positive/negative rates. Because if that's of no concern, I have a test to offer that's even cheaper.

    Though the required equipment is a bit larger than a credit card. Those magic-8-balls are kinda bulky.

    • That's what you get for the gratuitous use of high-tech machines. My coin-flip test is far more compact and requires no extra equipment.

    • Re: (Score:2)

      by ceoyoyo ( 59147 )

      You don't need a magic eight ball. It's a positive or negative result. A binary decision generator will work just fine.

      I have a bunch of those in stock. Form factors are discs, several sizes available, from 24.25 mm (diameter) x 1.75 mm (thickness) down to 18 mm x 1.35 mm.

  • It will be $5 for the test and $250 for the office visit

  • Covid-19 rapid tests have been available since at least January 2020, and they cost $1 each, and produce results in 3 to 10 minutes... I will say that thousands of them have been used to determine correctly whether someone has anti-bodies, and they are FDA approved. So, this story doesn't sound like its really telling the truth about the availability of these tests, its more of a marketing piece.

    • Re: (Score:2)

      by RDW ( 41497 )

      This isn't testing for antibodies (which indicate you were previously infected), it's testing for viral antigens (which indicate an active current infection).

  • I think I had COVID-19 in June. I need to prove my immunity to my employer.

    Where can I find an affordable COVID-19 antibody test?

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