Bacon's Rebellion

Democracy Thrives in Sunlight

Demand Rapid COVID-19 Testing

—

by

James A. Bacon
in

An Abbott ID NOW testing device for COVID-19.

by James C. Sherlock

Three days ago, I wrote the following:

Now it has turned out that by far the most effective and timely test for COVID-19 has been produced for point-of-care (physicians offices, clinics, etc.) testing, not for centralized test labs. That fact has left the hospitals and the administration collectively clueless. … Daily 50,000 of the FDA-approved COVID-19 tests that run on ID NOW are being shipped by Abbott. The test requires about 3 minutes to provide a confirmed positive, and less than 15 minutes to produce a confirmed negative. It is likely that the tests shipments are being directed to the hottest of the hot spots, but Virginians do not know if that is true or when and where they might be available here. Portions of Virginia itself will likely join hotspot lists shortly.

Later that same day Yahoo News reported:

“The state of Georgia (had) joined forces with CVS Health to increase access to rapid coronavirus testing. Starting Monday (April 5), CVS will be operating drive-thru rapid coronavirus testing, offered by Abbott Laboratories, at a site on Georgia Tech’s campus. At full capacity, the site will be able to conduct up to 1,000 tests per day.”

It is time for Virginians to stop asking and start demanding.

Each reader should contact his or her state delegate and senator and demand to know when we will see these tests in Virginia and ask why the Northam administration and VHHA continue to seem clueless about the existence of such tests, much less make them available to Virginians.

You can find contact information for your state representative here.

Here is a message example. Please send it either to their websites if that is where they take constituent inputs or to their offices or both:

Subject:  Rapid COVID-19 testing

Dear Senator ____ or Delegate ____, I am a constituent. We need help improving COVID-19 testing, and the Commonwealth seems to be far behind where we should be. 

By far the most effective and rapid test for COVID-19 has been produced by Abbott labs for point-of-care (physicians offices, urgent care clinics, etc.) testing, not for centralized test labs.

The Abbott ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster) and is already the most widely available molecular point-of-care testing platform in the U.S. today. It has been used for a long time for such things as testing for strep. 

It is statistically likely that about 450 of these platforms are available in Virginia today, but we do not know how many we actually have, where they are and whether or when they will have the Abbott COVID test modules to run on them.

Abbott is shipping 50,000 of the FDA-approved COVID-19 tests that run on Abbott’s ID NOW platform every day. The test requires about 3 minutes to provide a confirmed positive, and less that 15 minutes to produce a confirmed negative.

These facts have left Virginia’s state lab, the hospitals and thus the Northam administration collectively clueless. The state runs laboratory test platforms with 24- to 48-hour processing turnarounds, not point-of-care platforms with 15-minute turnarounds.

The state of Georgia has joined forces with CVS Health to increase access to rapid coronavirus testing. Starting Monday, April 5, CVS has been operating drive-thru rapid coronavirus testing using Abbott’s point-of-care tests at a site on Georgia Tech’s campus. At full capacity, the site will be able to conduct up to 1,000 tests per day.

Virginians do not know when or where they might be available here. Portions of Virginia itself will likely join hotspot lists shortly.

We demand answers.

These messages will explode in their inboxes. If their legislative assistants are alert, the members will act on them today.

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Comments

61 responses to “Demand Rapid COVID-19 Testing”

  1. Nancy_Naive Avatar
    Nancy_Naive

    The problem is that for most of these tests, you’ve no guarantee of quality. They have not undergone extensive tests. The FDA has waived requirements and you only have the manufacturers claim. Kinda like any of the cures on cable channels at 2 AM.
    Since disease causation is impossible there will be virtually no remedy should you test negative, not seek hospitalization because of it, and die from the disease 3 days later.

    1. sherlockj Avatar
      sherlockj

      It is objectively untrue that FDA has waived requirements. The Abbott test to which I refer is FDA approved. The science of that approval is straightforward. Please do not spread disinformation on something you clearly know nothing about. As for your second paragraph, it is worse than the first. What the heck is “disease causation is impossible” supposed to mean?

      1. Nancy_Naive Avatar
        Nancy_Naive

        FYI, the assay device and the method are approved. The SARS-COV-2 use has NOT undergone full approval.

        From Abbott’s site…
        “ABBOTT REALTIME SARS-COV-2 A qualitative assay for use under the FDA Emergency Use Authorization (EUA) to support efforts in COVID-19 testing…”
        https://www.molecular.abbott/us/en/home

        Frome the FDA… “About Emergency Use Authorizations (EUAs)… 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.”
        https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#abouteuas
        …..
        Five years hence… (things on TV go all wobbly and weird music plays)… “Abbott Labs, a leading manufacturer of medical equipment has set aside $10.2 million (of its $2.6B in profits) to settle claims that their PCR assay for SARS-COV-2, released under FDA Emergency Use Authorization (EUA), may have not have functioned to the levels of manufacturer’s claims at the time. So, if you or a loved one suffered permanent lung damage or death as a result of a false negative result, call the law offices of Dewey, Cheatem, and Howe at 1-800-…. Time is running out for you to receive your share (1/3Mth of the settlement after 50% legal expenses, or $3.40)…”

      2. Nancy_Naive Avatar
        Nancy_Naive

        crickets?

        1. sherlockj Avatar
          sherlockj

          See my comment at the bottom of this list

  2. LarrytheG Avatar
    LarrytheG

    The “centralized” labs have largely been used for many doctors and other providers all along – like Quest and LabCorp.

    Doctors have always been able to do point-of-care tests for various things and actually even individuals for thing like blood glucose and other home test kits.

    No matter how/where the tests are done – regional/central labs or point of care of home – there is a need to the tests to be standardized. There are a number of different manufacturers – but are their test kits standardized – to the point where any test swab can be put into any manufacturers box?

    That’s just part of it.

    The next part is how is the data managed? Who gets the results? Is there a standardized way to report the results so that, for instance, an employer can verify that employees have been tested and are virus-free? How often does that test need to be done to assure that the employee has not become infected? Once a day, once a week? whenever the employee has a high temperature of the sniffles?

    All of this requires a standardized approach regardless of how decentralized the actual testing is.

    This is a job for professionals in the field – and it requires coordination and agreement between all the entities that would be involved in the testing itself as well as reporting the results.

    It’s frustrating as hell for most of us that this is not yet done and that it probably should have been started months ago.

    I don’t think yelling at the legislators in the Va GA is going to do much. Most of them are also “clueless” about a lot of this – they’re just ordinary part-time legislators and on a wide variety of issues, it’s clear they are not exactly geniuses…. they relay on professional staffs and lobbyists… etc.. for info and my bet is that there is not a common perspective yet on how to go forward. All kinds of voices and opinions… in the “wild”, it does appear that most epidemiologists are pretty much in agreement on how to go forward. Getting everyone else on board when we argue about virtually everything is no small feat.

    1. Steve Haner Avatar
      Steve Haner

      You and Nancy are the problem. You really are. I will say this again — I am interested in Northam and Trump doing well, succeeding in this crisis, and you wake up every morning determined to push failure….You revel in it.

      Jim S, you are dead on correct. If such a test were available, I’d jump at it. It will be a game changer for the process of reopening the economy and restoring public confidence. Ignore these nattering nabobs of negativism.

      1. sherlockj Avatar
        sherlockj

        Perhaps the two first-to-the-blackboard commenters do not want to know their health status. Perhaps they would refuse testing. Perhaps they do not value early detection and treatment. Perhaps they do not want the Governor or the hospitals and therefore the citizens of Virginia to know about the availability of the high speed tests. Perhaps they ….. I can’t say it.
        If so, I surely don’t recommend that they write their General Assembly members, who would be as confused as the rest of us at their comments.

        1. LarrytheG Avatar
          LarrytheG

          Jim – there is a reason why we have not done universal testing in the USA. It has NOTHING TO DO with “commenters on BR” except in the minds of some folks who see things in partisan ways.

          I’m sorry that you seem to – and just seem to want to use this blog as a paltform to attack PEOPLE that you do not personall like.

          re: who wants to know about high-speed tests?

          EVERYONE DOES – what makes you think or say otherwise ?

          The problem is and has always been that you need ENOUGH of them for everyone AND you need a standardized way to report and manage the testing results and some uniform standards on how long the tests are good for before a re-test is needed.

          People who work in hospitals – if they have the tests are being tested almost every day and for good reason. To this point, they have been priortized in getting the tests – including the Abbot fast-tests. There have not been enough left over to do widespread testing.

          That’s not because anyone is opposed to it – it’s a simple reality – the truth.

          Why do you want to make this partisan? I do not get you guys.

        2. djrippert Avatar
          djrippert

          Of course you’re right. Anybody who doesn’t believe in the Abbot Labs test can continue to hide under their beds waiting for the Northam Administration to get to them. Northam’s 2,000 tests per day will have the entire population of Virginia tested once by November 23, 2031. That’s the actual date.

          1. idiocracy Avatar
            idiocracy

            Well, actually, the entire population of Virginia might be tested ahead of schedule, depending on how many people get fed up with this clown show of a state and move out.

          2. Reed Fawell 3rd Avatar
            Reed Fawell 3rd

            I agree with you. The state of Virginia government in practical affect, by its actions and failures to act, plan and lead has surrendered up the citizens of Virginia to this COVET-19 virus.

            Adding insult to injury the state’s leaders race bait and pander to their supporters. This is the powerful ongoing subtext and message of the state.

            See, for example, Governor Northam’s “press briefing” yesterday on COVET-19. It is painful to watch.

      2. Nancy_Naive Avatar
        Nancy_Naive

        I’m not “pushing” it. I’m predicting it based solely on Trump’s inability to grasp any concept more complicated than blackmail.

        Key phrase: ” If such a test were available…”

        It’s not. Bill Gates said this better than I ever could on CNBC this AM. His interview will, if not already, be available on the CNBC website.

        1. Acbar Avatar
          Acbar

          This is similar to the Gates interview by Judy Woodruff on PBS NewHour two days ago, here, in two parts: https://youtu.be/W3qz9-bxljA and https://youtu.be/BEJllllHUkI

  3. LarrytheG Avatar
    LarrytheG

    No. Steve, I would submit it is YOU and your ILK who are the problem.

    Not a thing I said up above had anything to do with politics… nothing.. it had to do solely with the idea of testing and how it should be done and why it was more difficult to do than simple-minded ideas.

    There’s a reason why we STILL do not have universal testing and the reasons why are what I alluded to above.

    You have to have a uniform, standardized testing regime – both the testing itself and the reporting and management of the data so that those who rely on the test information can make informed decisions about

    YOU are the problem Steve. Everything has to be partisan and any comments from folks you disagree with makes it partisan.

    1. Steve Haner Avatar
      Steve Haner

      “Simple minded?” You just put yourself out as smarter than the folks at Abbott Labs, CVS and the State of Georgia, and the folks at the FDA who are now (finally) approving all these new testing technologies? A medical specialty group for respiratory illnesses yesterday endorsed the malaria drug as a treatment. You attacked that idea from the get go. “I trust the government first” is the most simple minded statement I’ve ever seen.

      1. LarrytheG Avatar
        LarrytheG

        NO I do not – listen to the experts who are saying how widespread testing must be done. It’s much more than simple-minded ideas.

        You are flat wrong Steve. We have to have standards for things to “work”, it has nothing to do with government- left or right.

        The tires on your car meet a standard. Without that standard, tires would be the wild wild west.

        It works that way for virtually everything we use and depend on – INCLUDING testing.

        If you take a look at the population of Georgia and calculate out how many would have to be tested statewide to achieve the goal – the reason why to test – you’ll see that thousands of people would have to be tested every day – far more than what they have with CVS alone.

        If you’re not going to do testing statewide – and people move around all over the state – how will that work? How will anyone who has been tested “prove” that they are virus-free to anyone else? And how long will that time period of virus-free still be valid or not and a re-test has to be done?

        DO you think about this at all guy?

        1. djrippert Avatar
          djrippert

          Stay under your bed hiding from the virus until Ralph Northam calls you with the scheduled time for your test. At 2,000 tests per day statewide (only twice the rate of a single CVS in Georgia) the average Virginian will be tested in about 5 1/2 years. Hopefully you won’t be toward the end of the queue because that will mean you wait until 2031.

          Only somebody from the lunatic fringe of the left could have spent the last three weeks proclaiming the criticality of testing to stop COVID-19 and then abruptly insist that testing can wait once a private company end runs the government with a test that works at scale.

          “If you’re not going to do testing statewide – and people move around all over the state – how will that work? How will anyone who has been tested “prove” that they are virus-free to anyone else? And how long will that time period of virus-free still be valid or not and a re-test has to be done?”

          You’re right – South Korea and Germany don’t exist.

          1. LarrytheG Avatar
            LarrytheG

            re: ” And how long will that time period of virus-free still be valid or not and a re-test has to be done?”

            You’re right – South Korea and Germany don’t exist.”

            You’re talking out of both sides here DJ.

            The SOUTH KORES thing …….IS THE POINT

            and you wrote this upthread:

            ” At 2,000 tests per day statewide (only twice the rate of a single CVS in Georgia) the average Virginian will be tested in about 5 1/2 years. Hopefully you won’t be toward the end of the queue because that will mean you wait until 2031.”

            How many tests per day do we need for this to work on a statewide basis?

            are you going to hide under your bed until when?

  4. Reed Fawell 3rd Avatar
    Reed Fawell 3rd

    Jim S. and Steve are correct.

    I believe the obstinate refusal of the Northam Administration to provide full, efficient, and readily obtainable COVID-19 testing to all Virginia citizens is beyond highly irresponsible. This failure no doubt will directly lead to far more death and illness among Virginian over the near, mid, and long term. The failure also will severely impact in a very adverse way, Virginia’s ability to its economy and businesses back to full pre-Covid-19 health.

    I also find Northam’s obsessive lecturing on race and the health of Virginia’s ABC beverage business to be particularly despicable, his fetish pandering for money and votes in the times of health crisis.

    1. Nancy_Naive Avatar
      Nancy_Naive

      How often are you going to test any given individual? Hourly? Daily? Any any test that has a queue time of 24 hours is worthless in the midst of an epidemic for making decisions on who is safe to return to normal life and who is not.

      1. djrippert Avatar
        djrippert

        You’re right – South Korea and Germany don’t exist. They are not countries that have effectively used COVID-19 testing they are hallucinations from the far right echo chamber. Testing is just another “Orange Man Bad” deception.

  5. Atlas Rand Avatar
    Atlas Rand

    So I guess Larry is suggesting that we do no tests until the US has 330-350 million ready to go. Then we all trot down to our local testing center and get our swabs done at the same time!

  6. LarrytheG Avatar
    LarrytheG

    Nope. I’m relating what the scientists are saying… that it’s not an easy thing
    to test everyone and if you don’t test everyone – you’re going to have people who are infected – infecting others who have been tested and said to be virus-free.

    it has to be a wider and more uniform effort that doing it in isolated places – unless you are going to lock down the borders around those areas where people have been tested.

  7. Nancy_Naive Avatar
    Nancy_Naive

    And… file your taxes. Jeez, you’ve spent more time here than it would take.

  8. LarrytheG Avatar
    LarrytheG

    I am amazed that the simple questions of how often someone needs to be tested are not addressed by the “test now” folks especially if those that have been tested are going to be in contact with others who have not.

    This is NOT a “partisan” question folks.

    how is partial testing going to be effective?

    1. djrippert Avatar
      djrippert

      Ask the South Koreans how testing works. You can call them at work today.

      1. LarrytheG Avatar
        LarrytheG

        they’re testing their ENTIRE population DJ. Are you advocating that?

        when do you think we can do that? Is doing it partially going to work?

        answers? are there some intelligent answers here?

      2. Nancy_Naive Avatar
        Nancy_Naive

        I’d rather ask them why Trump was so late in enforcing “social distancing” and shutdown.

        South Korean actions…
        Lesson 1: Intervene Fast, Before It’s a Crisis — Just one week after the country’s first case was diagnosed in late January, government officials met with representatives from several medical companies. They urged the companies to begin immediately developing coronavirus test kits for mass production, promising emergency approval.

        Oh well, Trump blew that…”There’s 15 people, or 14 and soon that’ll be one and maybe he gets better, uh, uh, uh..”

        Lesson 2: Test Early, Often and Safely — South Korea has tested far more people for the coronavirus than any other country, enabling it to isolate and treat many people soon after they are infected.

        March 17th “I knew it was a pandemic all along…” but he still refuses to institute Federal testing plans.

        Lesson 3: Contact Tracing, Isolation and Surveillance — When someone tests positive, health workers retrace the patient’s recent movements to find, test — and, if necessary, isolate — anyone the person may have had contact with, a process known as contact tracing.

        Wait, why that’s an invasion of privacy!

        Lesson 4: Enlist The Public’s Help — There aren’t enough health workers or body-temperature scanners to track everybody, so everyday people must pitch in.

        Fox News is still saying it’s not an epidemic.

    2. Nancy_Naive Avatar
      Nancy_Naive

      It’s not “partial testing”. It’s minuscule testing. They CANNOT approach anything like 0.1 of 1% of the population if every lab was pumping it out at 10x capacity. Even if they hit THAT number, what then, test them all again by 2022?

  9. johnrandolphofroanoke Avatar
    johnrandolphofroanoke

    We are truely blessed to live in a country that guarantees our right to discuss this topic in public without fear. I bet it is hard to have this discussion in mainland China right now.

    1. Nancy_Naive Avatar
      Nancy_Naive

      Aye… and we are free to watch, and worse, believe Fox News.

      1. johnrandolphofroanoke Avatar
        johnrandolphofroanoke

        Come on! Throw me a bone. What is your puppies name? Cute little fellow.

        1. Nancy_Naive Avatar
          Nancy_Naive

          Jack. Gone 3.5 years after 15 wonderful years and one really crappy day. Yorkie/Russel mix. An accomplished ratter and fearlessly treed raccoons twice his size on a nightly basis.

    2. LarrytheG Avatar
      LarrytheG

      re: ” I think there is a great deal of give and take on this blog. Mr. Bacon has created a space where we can exchange ideas and listen to each other with an occasional spitball or paper airplane thrown in.”

      he has and he does, but I can tell you as someone who has been here awhile that things have gotten worse and name-calling in the blog posts themselves when it was not that way originally. That’s not good. It encourages that behavior in the comments – and you see it here especially when topics have strong opinions.

      “I do listen to you Mr. Larry. I don’t agree with Mr. Peter on a great many things but I do want to hear from him. I hope Mr. Peter doesn’t mind hearing from me every now and again. I suppose in a strange way we need each other. Right? Sort of like the way Jefferson and Adams needed each other.”

      Don’t want to put words in Mr. Peter’s mouth but I’m pretty sure he’s just fine with any comments that do not name-call or impugn him as a person.
      Same here… I think there is value in exchanging views – without name-calling… or worse.

  10. Dick Hall-Sizemore Avatar
    Dick Hall-Sizemore

    As with all tests, this one seems to be in short supply. Bloomberg reported this a couple of days ago:

    “Public-health labs are only expected to get 5,500 of those tests, according to a document circulated among HHS and Federal Emergency Management Agency employees that was publicized by Kaiser Health News. An Abbott spokesperson said that in addition to those tests, it had shipped more than 190,000 tests to 21 states as of Friday, prioritizing outbreak hotspots.”

    So, we can demand all we want. If the supply is not sufficient, demand will not ensure that we get anything. As soon as it is widely available, this test could be very helpful. However, should social distancing be eased as soon as it is available? How do I know that guy standing next to me coughing (1) has been tested and (2) has tested negative, thus meaning that he is just suffering from pollen and not the virus?

    1. LarrytheG Avatar
      LarrytheG

      re: ” So, we can demand all we want. If the supply is not sufficient, demand will not ensure that we get anything.”

      well no.. apparently it’s Northams fault… don’t try using logic or reason , Dick!

  11. Mergus Avatar
    Mergus

    https://theinterfaceofdataandlife.files.wordpress.com/2016/01/image.png

    Just going to remind all of you of the argument pyramid shared a few weeks back, and linked above. This is not civil discourse, it’s name calling. And is a sad reflection on where this bit of hardship has taken people.

    Lastly, I’d honestly like to know why a libertarian/conservative blog feels that this testing regiment is the duty of the state government, that in normal times is disparaged as little more than an anchor on free will and the invisible hand of the free market. Obviously, I do not agree with that view point.

    Life cannot go back to normal without through, widespread and comprehensive testing. That can only be managed by the State. I’d hope that this essential role remembered when all this is over and we go back to bickering over the little things.

    1. Nancy_Naive Avatar
      Nancy_Naive

      It’s okay. “Nancy and Larry are the problem” is not name-calling. It’s the use of exemplar. I hold no animosity to the use of my name and personality as an illustration.
      They are forgiven.

      1. LarrytheG Avatar
        LarrytheG

        I was fully expecting it to be honest and fully expecting Jim to not intervene as he did with you yesterday.

        Jim – to his credit, initially created the blog to be a right-leaning, libertarian type blog free to all to comment as long as they were civil.

        Over time, it has degraded. Even the blog posts started using name calling and encouraged more of it in the comments.

        Finally, Jim stepped in but it does not feel he is doing it in a fair and equal way… and I wonder if he has changed his mind and really wants this blog to be like a lot of other right-leaning blogs that just do not tolerate points of view beyond their own.

        We’ll see how this plays out.

        1. johnrandolphofroanoke Avatar
          johnrandolphofroanoke

          I think there is a great deal of give and take on this blog. Mr. Bacon has created a space where we can exchange ideas and listen to each other with an occasional spitball or paper airplane thrown in. I do listen to you Mr. Larry. I don’t agree with Mr. Peter on a great many things but I do want to hear from him. I hope Mr. Peter doesn’t mind hearing from me every now and again. I suppose in a strange way we need each other. Right? Sort of like the way Jefferson and Adams needed each other.

          1. Reed Fawell 3rd Avatar
            Reed Fawell 3rd

            “Sort of like the way Jefferson and Adams needed each other.”

            Typically, I find your views highly congenial and very informed, and I suspect that you are well versed on the Jefferson Adams letters, but comparing those exchanges to these exchanges here on this blog might be, how to put it delicately, shall we say, “a bit of a stretch.”

          2. johnrandolphofroanoke Avatar
            johnrandolphofroanoke

            Jefferson and Adams wrote those letters in their old age. The Revolutionary generation was falling into the history pages. Those two men learned something about each other and it took 50 years to figure it out. You can still debate and argue and even agree. Just accept your probably not going to change any minds and a little sugar towards sensitivities can go a long ways.

          3. Reed Fawell 3rd Avatar
            Reed Fawell 3rd

            I liked Adams in his letters. Jefferson comes across as not so admirable, nor as trustworthy, quite the reverse in fact. Adams gave Jefferson too much deference, in my view. Adams seemed not to fully appreciate fact that he was the better man.

    2. Reed Fawell 3rd Avatar
      Reed Fawell 3rd

      “Lastly, I’d honestly like to know why a libertarian/conservative blog feels that this testing regiment is the duty of the state government.”

      Because, that is the state’s reserved sovereign power under the United States Constitution. Hamilton, (and Madison too I believe), lost that argument.

  12. Nancy_Naive Avatar
    Nancy_Naive

    Trump’s most sound medical advice to date, “Take two APCs and call you governor next month.”

  13. LarrytheG Avatar
    LarrytheG

    No one in this blog should mistake what I have advocated FOR – almost from the beginning and that is nation-wide testing and a way for us to know who has been tested and the last time.

    it’s the only way for widespread testing to work.

    It’s not a “left” or “right” political thing.

    It does no good to test ONLY SOME people if we do not test everyone else – because they will still have infected in their numbers and if they mix with those who have been tested – they will infect them – and the “good test” results are only good for as long as it took for them to be infected from mixing.

    Again – this has nothing what-so-ever to do with politics…

    Those who insist it does – well.. I just don’t know anymore… it’s like simple facts and realities are also “political”.

  14. sherlockj Avatar
    sherlockj

    Dear Nancy, hate to break it to you, BUT ALL OF THE COVID-19 TESTS BEING USED TODAY IN LABS IN AMERICA HAVE BEEN APPROVED UNDER EUAs. The EUA IS REPEAT IS the FDA approval for all of them. The Abbott m2000 RealTime SARS-CoV-2 is being run by many labs on Abbott laboratory scale test platforms. It is so good that Dr. Birks asked publicly for labs owning the Abbott platform run the Abbott test instead of others because it had come to her attention that some were not doing so.
    The Abbott point-of-care test is the first one available to be run on a point of care testing platform. Fortunately it is run on the platform by far the most most widely available, the Abbott ID NOW.
    Please stop demanding my time to correct you.

  15. Nancy_Naive Avatar
    Nancy_Naive

    Frome the FDA… “About Emergency Use Authorizations (EUAs)… 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.”
    https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#abouteuas
    …..
    It is “permission” not “approval” as witnessed by the repeated use of the word “unapproved” and the last 9 words in the above paragraph.
    English, man, used it. Properly used, it is very specific…
    “The commissioner may ALLOW UNAPPROVED”
    CAPT, huh?

  16. sherlockj Avatar
    sherlockj

    So don’t ever get a test for any previously unknown deadly virus that pops up. Such tests will never have the formal approval you seek, which generally takes 18 months. Stay safe. Or not.
    Now, one last time, a few straightforward questions. Short answers please:
    1. Do you agree with the column recommendation that seeks General Assembly help to get the Northam administration to at least indicate that they understand that the point-of-care test is available, or do you not?
    2. Would you like the Northam administration to ensure it is available for Virginians, or would you not?
    3. If you get symptoms, do you want to be tested with it when it is, or do you not?
    4. If ill, would you rather wait 48 hours for the test results, or 15 minutes?
    Just asking. Under my authority in this crisis, I will allow, but will not formally approve, your answers since that is the only option afforded me under the law.

    1. Acbar Avatar
      Acbar

      Yes.
      Yes.
      Right away of course.
      Fifteen minutes of course.

      But the response I keep seeing from naysayers and enthusiasts alike is, “they aren’t available.” This is dismissive BS. Abbott is making them as fast as it can and ramping up its capacity — it will catch up with the demand in a month or so. Who out there thinks, realistically, that this pandemic is going to be over in less than that time? No — even if we can get some semblance of normalcy back by returning to work and to normal commercial hours, THERE IS NO QUESTION WE WILL NOT BE GATHERING IN CROWDS AGAIN UNTIL A VACCINE HAS BECOME WIDELY AVAILABLE. That will be, at best, this winter or next spring. We are going to tamp down this summer’s peak alright, but then be engaged in an ongoing, constant game of wac-a-mole to prevent a resurgence, until a vaccine arrives. To keep the virus’ spread suppressed and to allow people to mingle again in small numbers, THAT’S PRECISELY WHEN YOU NEED TESTING THE MOST! So let’s get ready for that day, Mr. Northam: even if you can’t get the tests any faster than other states during this initial caseload surge, it’s afterwards when we are really going to need them.

      1. LarrytheG Avatar
        LarrytheG

        The testing has to be wide and deep if we are going to get back to some semblance of normalcy.

        The simple reality is that getting a test won’t help you – if you get infected the next day by someone who did not get the test.

        This is the exact problem for medical personnel but it also the problem in our society because we do not know who is infected or not and if they are, how many they have contacted and also infected.

        the only way to deal with this is to test as many as we can and that is exactly why the Abbot tests are so important.

        But from what I have seen on the news, there is not nearly enough of them to go around and many states, including Virginia cannot get enough of them right away so widespread testing can be done.

        The funny thing is – not funny – is that folks do not even agree about whether we need to have widespread testing or not….

        We do. There is no question, we do – until and unless we get a vaccine or some other miracle happens.

        We are lucky in one sense – this virus does not morph into variants very fast. If it did, we’d be chasing the vaccines for years.

  17. sherlockj Avatar
    sherlockj

    One last note, Nancy. If you get sick and don’t wish to be tested for COVID-19 with a test that was authorized under an EUA, you must refuse testing. If you do so, I suspect you will not be treated. I’m thinking that is probably not the route you will choose, but no one can know but you. Good luck.

    1. Nancy_Naive Avatar
      Nancy_Naive

      “FDA Approved” — it has legal ramifications and guarantees performance.
      “Emergency Use Authorization” — does not.

      Since early February, the FDA has granted roughly two dozen emergency authorizations for clinical tests to detect the virus. The tests were developed by governments ― including the CDC and the New York state public health lab — and multiple private companies such as LabCorp, Quest Diagnostics, Roche Diagnostics and Thermo Fisher Scientific.

      Yet providers have reported rampant problems with COVID-19 tests giving false negatives, in which the virus is not detected even in an infected person.

      https://khn.org/news/trump-touted-abbotts-quick-covid-19-test-hhs-document-shows-only-5500-are-on-way-for-entire-u-s/

      YOUR LIFE depends on ZERO false negatives. A false negative is a condom manufactured to MIL-SPEC. I always loved the test description for “Permissible Leaks”. PERMISSIBLE???

  18. cjbova Avatar
    cjbova

    There is an urgent need for more testing. Beyond identifying those who are positive, the need is to identify those who have or will have recovered so they can donate blood for antibody testing and research on a vaccine. There’s the additional benefit of knowing who has developed antibodies for returning to work scenarios.

    Writing to our legislators seems like a good move now. Right now, we don’t know what the state’s game plan is about testing, how many are available, why their guidelines are restricted to certain classes of people with symptoms, and whether there is a state-wide strategy in play, and if so, what it is. How will the Abbott test work into that strategy? Why hasn’t VHHA said more about it?

    If as JAB suggested, it’s a lack of PPE, where is the state on dealing with that? There was an ad from a manufacturer unable to get enough supplies to keep all his machines running. Did anyone in the administration respond to that?

    We need to know more than footnotes on the VDH statistics page about under-representing the number of hospitalized and failure to report negatives because there are too many faxed reports from new testing labs. What actions are being taken?

    1. LarrytheG Avatar
      LarrytheG

      more testing without rhyme or reason will not help.

      We have to understand that anyone who has been tested – can be infected the next day from someone who had not been tested.

      that tells us the limits of testing. You have to do it across the board or it will
      lull one into thinking it “works”.

      Testing has to be for virtually everyone (and it needs to be repeated). and/or we need to separate those whom have not been tested from those that have.

      1. sherlockj Avatar
        sherlockj

        Right now, you should get the test if you have the symptoms. That is the guidance. That is both rhyme and reason. If there were more tests than were needed for those with symptoms, the next group tested would be those most likely to be killed by COVID-19, seniors and those with comorbidities. If there were more than that, then people who wanted to go back to work. Then when more than that, everyone.

      2. Nancy_Naive Avatar
        Nancy_Naive

        “Testing has to be for virtually everyone (and it needs to be repeated). and/or we need to separate those whom have not been tested from those that have.”

        WITH ACCURACY!

  19. Acbar Avatar
    Acbar

    We should all join this chorus. JS and SH are correct: “If such a test were available, I’d jump at it. It will be a game changer for the process of reopening the economy and restoring public confidence. ” The Abbott fast test will become increasingly available this month (and we are going to need massive testing for the rest of this calendar year, at least) — we should be constructing the drive-through stations in readiness NOW to administer them as fast as we can get them. Also there are the test reading machines to purchase and distribute.
    Thanks, JS, for the form letter.

  20. cjbova Avatar
    cjbova

    This is why we need wide testing and need it now:
    Just came across this from Johns Hopkins:
    https://hub.jhu.edu/2020/04/08/arturo-casadevall-blood-sera-profile/

    “A promising COVID-19 treatment gets fast-tracked
    Arturo Casadevall and collaborators at Johns Hopkins and beyond have worked around the clock to develop a convalescent serum therapy to treat COVID-19 using blood plasma from recovered patients. If early promising studies on the therapy done in China are confirmed by U.S. trials, thousands of survivors might soon line up to donate their antibody-rich plasma. “I absolutely think this could be the best treatment we have for the next few months,” Hopkins pathologist Aaron Tobian says.

    On March 24, the U.S. Food and Drug Administration began allowing researchers to request emergency authorization for its use. Within three days hospitals in Houston and New York City started treatments, and now under a FDA “expanded access program” soon “a very large number” of U.S. hospitals will follow suit, according to Tobian.”

    “On Friday, the FDA approved a clinical trial specifically for Johns Hopkins that will allow its researchers to further test the therapy as a means of preventing otherwise healthy people, notably front-line medical staff, from getting sick. FDA approval is pending for a second Hopkins clinical trial on patients who are slightly or moderately ill to see if the serum will keep them out of ICUs and help bring them back to health.”

    Lots more… read it!

  21. cjbova Avatar
    cjbova

    From the above article:
    “The Red Cross is seeking people who are fully recovered from COVID-19 and may be able to donate plasma to help current patients with serious or immediately life-threatening COVID-19 infections, or those judged by a health care provider to be at high risk of progression to severe or life-threatening disease. For more information, visit the website of the American Red Cross.”

    From the Red Cross: On March 30, we established a new webpage, RedCrossBlood.org/plasma4covid, to help collect prospective donor information. Eligible donors who submit their information will receive an appointment to donate convalescent plasma at a Red Cross or non-Red Cross collection site.

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