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Biotech Government Medicine United States

America's FDA Authorizes Fast Coronavirus Testing System (thehill.com) 105

America's Food and Drug Administration has approved a coronavirus test from a company called Cepheid.

It can deliver its results in about 45 minutes, "much faster than current tests that require a sample to be sent to a centralized lab, where results can take days," reports The Hill: The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide, of which 5,000 are in the U.S., the company said. The systems are already being used to test for conditions such as HIV and tuberculosis. The systems do not require users to have specialty training to perform testing and are capable of running around the clock.

"An accurate test delivered close to the patient can be transformative" and can "help alleviate the pressure" that the COVID-19 outbreak has put on health facilities, David Persing, Cepheid's chief medical and technology officer, said in a statement.

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America's FDA Authorizes Fast Coronavirus Testing System

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  • by Lije Baley ( 88936 ) on Saturday March 21, 2020 @02:47PM (#59857376)

    In other news, health officials in NY and CA are starting to limit testing, not just because the tests were scarce, but because they decided it really won't help anything but the statistics at this point.
    https://www.cnn.com/world/live-news/coronavirus-outbreak-03-21-20-intl-hnk/h_78c431662464112a27434663a0860cdc/ [cnn.com]

    • Re: (Score:3, Insightful)

      by dgatwood ( 11270 )

      More like they don't want everyone to see how miserably they have failed at containing this.

      • There was never any hope of "containing" this. You can't stop a virus whose host is contagious for several days without showing any symptoms. Your best hope is to slow the spread so health care services don't collapse.

        • by AleRunner ( 4556245 ) on Saturday March 21, 2020 @03:39PM (#59857494)

          There was never any hope of "containing" this. You can't stop a virus whose host is contagious for several days without showing any symptoms. .

          And yet several countries have done actually done this. Taiwan, South Korea, New Zealand and apparently even China. It's an effort; it involves isolating all of the contacts of each newly identified infection. It costs brain space (more than money - failing to do this costs more) and needs to be tried repeatedly for a while since you will have multiple failures, however it's wierd to claim it's impossible when people are actually doing it. I guess in the modern world we don't need reality to agree with our beliefs?

          • by Some Guy I Dont Know ( 6200212 ) on Saturday March 21, 2020 @04:49PM (#59857636)

            South Korea arrested - as in, filed criminal charges - against a bunch of people they accused of not isolating when potentially infected.

            That police state attitude will do a LOT to cut down on the spread of the disease, along with Taiwan's police "protective custody" of patients. Also, China? Contain? Are you fucking kidding me? Where the hell do you think the rest of the world got the disease from?

            • China? Contain? Are you fucking kidding me? Where the hell do you think the rest of the world got the disease from?

              They mean that while the infection rate is sky rocketing in most other countries (the graph is virtually vertical), China has managed to flatten the curve.

              https://www.worldometers.info/coronavirus/country/china/

              Whether or not the numbers coming from China can be trusted is another story.

              • China's looking a lot better. Worldometer is a good site. As a very rough estimate I'd say that the US is at least 1/3 through the rough part.

            • South Korea arrested - as in, filed criminal charges - against a bunch of people they accused of not isolating when potentially infected. That police state attitude will do a LOT to cut down on the spread of the disease, along with Taiwan's police "protective custody" of patients.

              Actually, no, it will make very little difference at all. Immediate execution by firing squad broadcast on TV after the daily "Coronavirus Update" will make a difference.

              This should be expected in the US in a couple more days.

          • The culture in Asia is more conducive to drastic action like quarantines and containment. Confucianism emphasizes prioritizing the good of the group (family, town, company, country, etc) over the individual. That's why Asians are so big about family members taking care of each other. So if the government imposes a nationwide curfew, people in general will comply.

            Western cultures OTOH emphasize individuality, which results in a higher percentage of people who'll just ignore the government if it calls f
            • Wondering what the "cultural" contribute, Cuba comes to mind. They've never been anything like Eastern societies. https://www.plenglish.com/ [plenglish.com] is covering the situation in all of Latin America. One might get some facts about of non-US, non-China approaches there.
            • The culture in Asia is more conducive to drastic action like quarantines and containment. Confucianism emphasizes...
              So if the government imposes a nationwide curfew, people in general will comply.

              Western cultures OTOH emphasize individuality, which results in a higher percentage of people who'll just ignore the government if it calls for a curfew.

              ~Solandri

              This framing neatly excises anthropology and McLuhan through the lens cultural studies 101.

              If asymptomatic transmission had resulted in the collapse of San Jose, CA (10th largest by population as Wuhan is) your conclusions about behavior and responses of self-preservation have less traction.

            • by gweihir ( 88907 )

              While I agree to the general point, there are different levels of quality in different countries. My impression is that in western societies, the more people actually influence what their government does and the more the government routinely has to explain why they are doing things and maybe even have to get confirmation by the voters for major decisions, the more people are in turn willing to listen to that government. Or course, there are always the young&stupid and the old&stupid and the generall

          • Korea hasn't stopped the virus, it's just spreading a lot slower.
        • by lamer01 ( 1097759 ) on Saturday March 21, 2020 @06:04PM (#59857796)
        • There was never any hope of "containing" this.

          There was, back in December when the Trump administration received the first intelligence warnings. But that opportunity was squandered.

          You can't stop a virus whose host is contagious for several days without showing any symptoms.

          You can. [theguardian.com] Read and learn.

        • Comment removed based on user account deletion
      • by fahrbot-bot ( 874524 ) on Saturday March 21, 2020 @04:31PM (#59857602)

        More like they don't want everyone to see how miserably they have failed at containing this.

        Of course, unless the government somehow forces people to stay away from other people and/or at home, it's the population itself that's failing to contain this.

        • Of course, unless the government somehow forces people to stay away from other people and/or at home, it's the population itself that's failing to contain this.

          ~fahrbot-bot

          I wholeheartedly agree:)

          Contagion is a word used to give emphasis to both the pathogen's characteristics and as equally to the conditions and circumstances of its hosts' behaviors to aid or diminish a pathogen's advance.

        • No help only self quarantine.

          The ruling class has its finger on the wheel and their cock in your mouth.

        • It is time for taking hard step to stop convid 19
        • it's the population itself that's failing to contain this

          Indeed. A population should be socially responsible such as following the advice from leaders. Unfortunately the USA's fuckwit in chief is on the air every other day telling people to not worry, it'll blow over, it's just like a cold, and summer is coming and sickness just disappears in summer.

          In the meantime places in Europe got emergency alerts reminding people of the severity of the damn thing and to keep distance from each other.

      • by gweihir ( 88907 )

        More like they don't want everyone to see how miserably they have failed at containing this.

        Indeed. The primary tool of incompetent officials is to move the evidence out of sight. It is also why so many documents get classified.

    • by Knuckles ( 8964 )

      Only because tests and materials are so limited that testing has to be focused on the cases where it makes the most difference. Read your own link please, we don't need misinformation now

      • by Lije Baley ( 88936 ) on Saturday March 21, 2020 @04:04PM (#59857554)

        I did read it, completely, and it mentions:
          1) A shift in strategy away from containment, meaning that they are no longer interested in trying to isolate people who are testing positive, presumably because in those states the policy is to isolate everyone at this point.
        2) They don't need testing to determine how to treat people. If you can't breathe, they just treat that, regardless of how it came to be.
        It makes sense, if you think it through. It's just a shame that we might not get better data about the spread of it.

        • Re: (Score:3, Insightful)

          by Knuckles ( 8964 )

          New York:
          "At this point in the pandemic, demand for unnecessary testing is contributing to the rapidly diminishing supply of PPE and leading to a decreasing supply of swabs and viral transport media used to collect diagnostic specimens for Covid-19 testing,"

          LA is less clear about it, but we know that test kits are in short supply and in this context their-no test rule 'unless “a diagnostic result will change clinical management or inform public health response.”' is clear enough, IMHO. In partic

    • Re: (Score:2, Informative)

      by Anonymous Coward

      Chinese culture accelerated the propagation of the coronavirus from China to the rest of the world. An analysis [nytimes.com] published by the New York Times explains how the Chinese tendency to hide the truth allowed the coronavirus to spread quickly.

      Get more info [blogspot.com] about Chinese culture.

      • by fahrbot-bot ( 874524 ) on Saturday March 21, 2020 @04:36PM (#59857604)

        Chinese culture accelerated the propagation of the coronavirus from China to the rest of the world. An analysis [nytimes.com] published by the New York Times explains how the Chinese tendency to hide the truth allowed the coronavirus to spread quickly.

        Cue videos of Trump Administration press briefings and campaign rallies from last month saying everything's fine and under control, nothing to see here ... In summary: an authoritarian government/leader is an authoritarian government/leader ...

    • by guruevi ( 827432 )

      South Korea told us that a month ago. Testing is useless, it didn't stop or limit the rate of spread or deaths. The demographics and culture are also different, they basically quarantined grandma until the virus ran its course across the young population. This method does work and kept their economy largely intact but they run a huge risk, instead of it petering out, having the virus continue circulating into another outbreak either now or later in fall. Only time can tell.

    • That's exactly my question. Why is "testing" such a big issue?

      There is no "cure" for Covid19. If you're feeling ill, a positive Covid19 test accomplishes nothing; there is no 'curative' drug applied once they confirm you have Covid19; neither are you rushed into intensive care because the vast, vast majority of sufferers will have a few symptoms and get better just fine.

      If you're feeling flu-like and you DO have Covid19, you should be going home, self-isolating, and taking care of yourself until you feel

    • Who told them that? It's dangerously wrong and directly contradicts the lessons learned in Korea. I posted it above, but it bears repeating - there is only one way to stop this virus: test and isolate. Test everybody, even if asymptomatic, because the virus spreads while asymptomatic. Learn more here. [theguardian.com]

  • ... of more people getting tested quicker, resulting of numbers going up quicker purely due to that, and the media claiming the world is ending.

    Just like they now deliberately confuse people tested and confirmed due to having symptoms with total people infected, so the ratio of recovering to dead looks orders of magnitude bigger.

    Or how they deliberately conceal how many of those sick or dead would have died soon anyway (e.g. with the next flu season).

    NOTE that I'm not saying we should not try to slow it dow

    • by JaredOfEuropa ( 526365 ) on Saturday March 21, 2020 @03:13PM (#59857440) Journal
      Fast and cheap tests could mean the difference between quarantining the vulnerable and infected, and effectively quarantining everybody, which is what is already happening in several countries. That should be good news to anyone worried about this ruining the economy even further than it already has.
      • Fast and cheap tests could mean the difference between quarantining the vulnerable and infected, and effectively quarantining everybody

        As I said before, relying entirely on testing assumes everyone is honest. You're assuming everyone who tests positive will obey their quarantine.

        Say testing works as you're hypothesizing, and you separate people into two groups - people who are quarantined, and people who can go about their regular lives. Once the latter group starts going about their regular lives, an

        • Re: (Score:2, Informative)

          Tests are not available to determine that someone can "go on about their regular lives". The only test available is capable of determining whether someone who is showing an immune response (what the proles call "flu" symptoms) has sufficient SARS-nCov-2 pro-viral RNA in their upper respiratory tract (the back of the nose) to turn on a light indicating that there is sufficient pro-viral RNA present that the immune response may be caused by SARS-nCoV-2.

          Notice that the test result is contingent on displaying

          • by Anonymous Coward

            Tests are not available to determine that someone can "go on about their regular lives". The only test available is capable of determining whether someone who is showing an immune response (what the proles call "flu" symptoms) has sufficient SARS-nCov-2 pro-viral RNA in their upper respiratory tract (the back of the nose) to turn on a light indicating that there is sufficient pro-viral RNA present that the immune response may be caused by SARS-nCoV-2.

            Notice that the test result is contingent on displaying evidence of a robust immune response. In the absence of a robust immune response THE TEST RESULTS ARE MEANINGLESS!

            What are you talking about?
            What makes you think an immune response is needed to detect the RNA of the virus. Are you confusing this with tests for antibodies? (IgG or IgM tests)
            No immune response at all is required at all to test for viral RNA. Just that the viral RNA is present. So even people who display no symptoms at all can still show positive in a test.

    • by Kernel Kurtz ( 182424 ) on Saturday March 21, 2020 @03:22PM (#59857458)

      Watch the funny results... of more people getting tested quicker, resulting of numbers going up quicker purely due to that, and the media claiming the world is ending.

      Actually, in the end the number of people who get it is completely unimportant, it will indeed be endemic one day.

      The only number that matters now is the number of people who need to be hospitalized for it simultaneously. It is far more deadly when health care systems are overwhelmed. And unfortunately that is not unlikely at all.

      • by AleRunner ( 4556245 ) on Saturday March 21, 2020 @03:44PM (#59857506)

        Actually, in the end the number of people who get it is completely unimportant, it will indeed be endemic one day.

        The only number that matters now is the number of people who need to be hospitalized for it simultaneously. It is far more deadly when health care systems are overwhelmed. And unfortunately that is not unlikely at all.

        The other key number is the length of time of effective quarantine. If you don't know whether someone is infected then suspected infections need 7 day quarantines and people living with the infected person need 14 days. If you can test them within 45 minutes, then you can do that daily over three days and you can then release everybody if they test negative. For a family of five that's a reduction from 63 to 15 quarantine days and possibly even a larger than proportional cost reduction. This is the difference between it being a minor inconvenience that everybody can cope with and being something which causes major economic disruption and may be questioned.

        • The correct tests to be of any use for these purposes do not yet exist.

        • This is the difference between it being a minor inconvenience that everybody can cope with and being something which causes major economic disruption and may be questioned.

          ~AleRunner

          You are proffering support of herd immunity (without vaccination) by conflating economic policy and the evolving procedures of saving lives.

          • This is the difference between it being a minor inconvenience that everybody can cope with and being something which causes major economic disruption and may be questioned.

            ~AleRunner

            You are proffering support of herd immunity (without vaccination) by conflating economic policy and the evolving procedures of saving lives.

            No, I don't support herd immunity at all and countering an argument by showing that it's self inconsistent is not the same as agreeing with the argument. With a high level of testing a) general herd immunity will never be achieved and b) we will be able to benefit from much lower levels of population immunity since tested people who know they are immune to the disease can be the only people in contact with infected patients meaning much lower risk of spread.

            Life saving is a priority and economics comes

      • Actually, in the end the number of people who get it is completely unimportant, it will indeed be endemic one day.

        Because coronavirus always goes endemic.

        That's why everyone eventually got MERS [cdc.gov] and a third of the whole world died. [who.int]

        • That's why everyone eventually got MERS [cdc.gov] and a third of the whole world died. [who.int]

          Hmm? 858 have died. That's 1/3 of 2494 cases since 2012.
          Ah, hell, nvrmnd. I missed the "sarcastic" tag.
          Carry on.

        • Some strains of what we call the common cold are coronaviruses (though most are rhinoviruses).

          Thankfully MERS is not nearly as contagious as this current one is. That would be apocalyptic.

          • Some strains of what we call the common cold are coronaviruses (though most are rhinoviruses).

            Thankfully MERS is not nearly as contagious as this current one is. That would be apocalyptic.

            Yes and some flowers are red.
            Did you have a point?
            You claimed coronavirus always become endemic. But that's not true, and I gave you an example. You showing me another one doesn't prove your point. Any more than me showing one flower is red proves all flowers are red. A single purple one is enough to prove that wrong.

            • You claimed coronavirus always become endemic.

              Feel free to quote me on that. I won't hold my breath.

              I said this one will be. I'm no expert, but still happy to not be as clueless about viruses as you.

              • Feel free to quote me on that. I won't hold my breath.

                What did you mean here [slashdot.org] then?

                Actually, in the end the number of people who get it is completely unimportant, it will indeed be endemic one day.

                What did you base that prediction on? You certainly implied the reason was some colds were coronavirus and they were endemic.
                What do you think you meant instead?

                You said this one will be, but now can't think of any other reason as to why you thought that.
                'It will indeed' is prety strong language for an admitted completely uneducated guess. Dunning-Kruger perhaps? At least you realise now that you were just spitballing ideas.

                still happy to not be as clueless about viruses as you.

                LOL

                • I was speaking of this particular virus, and many if not most actual virologists do believe it will be endemic one day, just another one of the many strains of respiratory viruses that circulate regularly.

                  Anything else you read into it is all your own.

                  "The emerging consensus among epidemiologists is that the most likely outcome of this outbreak is a new seasonal disease—a fifth “endemic” coronavirus."

                  https://www.theatlantic.com/he... [theatlantic.com]

                  https://www.healthline.com/hea... [healthline.com]

    • .. of more people getting tested quicker, resulting of numbers going up quicker purely due to that,

      That's called "the past week"

      There's been a lot more testing, so you see all kinds of charts about how the U.S. is on the same course as Italy purely because numbers that come from testing are rising rapidly as more tests have been done.

      Meanwhile the death rate is much flatter, and much more easily verified than the total number of people actually infected, or in fact already over it.

      But you're right in essenc

      • Comment removed based on user account deletion
        • There is, at present, no way to determine that. Current tests are based on testing for specific pro-viral RNA fragments. Only in the presence of robust immune system response (displaying symptoms, as it were, since the effects of the immune response and not the effects of the virus are what it causing death) are the tests of any use.

          Perhaps years from now IgM and IgG tests will be available to be able to test for infection and immunity much as can now be done for Measles, Mumps, Rubella, Varicella, Hepati

          • by dgatwood ( 11270 )

            Actually, a sizable number of people test positive despite being asymptomatic — about one in six, if memory serves. Yes, you have to have an immune response, but that's not the same thing as being symptomatic.

      • Meanwhile the death rate is much flatter, and much more easily verified than the total number of people actually infected, or in fact already over it.

        ~ SuperKendall

        Interesting qualifier "meanwhile". And of an "afterward", as crude mortality rate (CMR) is distinguished from case fatality rate (CFR) ourworldindata.org [ourworldindata.org] among many other variables, what number of deaths is sufficient to question your own ignorance to that of others'?

    • And evey social worker knows that divorces, domestic violence, and mental illness aren't just caused by what's in your head.
  • It can deliver its results in about 45 minutes,

    There are two ways to interpret this. Either each machine needs 45 minutes to perform 1 test, or it can steadily stream multiple tests - maybe tens or hundreds - and the result from the first test appears after 45 minutes. With subsequent ones popping out a minute or a couple of seconds after.

    If it is the first interpretation then 32 tests per machine per day, even having 5,000 machines is going to take a while to screen the whole country. If people have to queue for more than 3 days to take their turn, t

  • by hey! ( 33014 ) on Saturday March 21, 2020 @04:24PM (#59857586) Homepage Journal

    ... at least judging by the google search I did on the product.

    Apparently you dump the sample in a bar coded cartridge that contains all the stuff needed for the test (reverse transcriptase, DNA polymerase, and the primers and dyes specific to the thing you're looking for). You pop the cartridge into the machine where the sample is amplified and the DNA produced is bound to a fluorescent dye molecule. This allows the increasing product concentration to be continually measured with each amplification cycle.

    It's not groundbreaking from a molecular biology standpoint, but it's automated and conveniently packaged to be used close to where the samples are taken. This in itself eliminates a lot of the waiting from samples being shipped to an offsite lab.

    The problem is that this kind of test is proprietary in the way an ink cartridge is proprietary -- it only works if you have the manufacturer's machines. On the other hand, something like that machine is bound to be pretty useful in a lot of settings.

    • Comment removed based on user account deletion
      • by sixoh1 ( 996418 )

        Cepheid's installed US base is more than 20,000 systems and they are a subsidary of Danaher, so quite well placed to ramp up production of their cartidges.

        Roche also has a similar product, as does ThermoFischer, and both also have received FDA approval for their assays.

        So expect to see a dramatic increase in the total number of tests being run this week.

        • by hey! ( 33014 ) on Saturday March 21, 2020 @06:28PM (#59857862) Homepage Journal

          Robotic realtime rt-PCR is how South Korea limited the growth of the epidemic, churning out over ten thousand tests a day for a country 1/6th our size. We've only just reached that level of testing, and we really need to be doing 6x the number of tests Korea does daily.

          I spent many years working in public health informatics, so I've been watching the numbers daily, and there is as yet no sign of the US case load slacking. We're still riding the exponential wave. I expect in a week or so we'll see the impact of the business shut downs in the numbers, but before we can get back to work, we need a massive testing capacity in place.

  • by leonbev ( 111395 ) on Saturday March 21, 2020 @05:28PM (#59857708) Journal

    Their Edison testing machines that they were developing might have been able to have been modified to test for this virus. If they had actually been successful in their original design and had these things installed at your local Walgreens like they had planned, we might be an much different situation when it comes to coronavirus testing capability.

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