Unfortunately, the free market on antibody test kits is not reliable.

When tested by the FDA or its surrogates, many are unreliable. There are also a lot of bogus ones that tout FDA approval, but are not approved.

The FDA is in the process of screening over 200 test kits on the market. Apparently, without some kind of oversight, the buck prevails. If not an agency like the FDA, who else can we rely on?

21 thoughts on “Unfortunately, the free market on antibody test kits is not reliable.

    1. If you read your cite carefully you will see that the FDA is challenging the tests based on lack of approval but it does not cite a single case of a defective test.

      There maybe some, but that article does not establish that there is a real, rather than a regulatory,issue.


      1. “The Food and Drug Administration announced on Monday that companies selling coronavirus antibody tests must submit data proving accuracy within the next 10 days or face removal from the market.
        The antibody tests are an effort to detect whether a person had been infected with the coronavirus, but results have been widely varied. Since mid-March, the agency has permitted dozens of manufacturers to sell the tests without providing evidence that they are accurate.
        The F.D.A.’s action follows a report by more than 50 scientists, which found that only three out of 14 antibody tests gave consistently reliable results, and even the best had flaws. An evaluation by the National Institutes of Health, working with other federal health agencies, has also found “a concerning number” of commercial tests that are performing poorly, the F.D.A. said.“

        Now, would my doctor have sorted out which of the antibody tests were accurate? How would he know?

        Liked by 3 people

        1. I do not see that in the WAPO article Paul cited, was that in the NYT article?

          And your doctor knows he can trust well known labs but not to rely on a company he never heard of before March. Do you really think your doctor doesn’t know what companies he can trust? Do you think he will prescribe a test he saw in EBay?


          1. I edited my post and I suspect Len replied while I was editing, so his answer is likely for the first sentence, not the last.


      2. @Tabor
        If you read carefully you would find this in the headlines . . .

        “Previous hands-off approach resulted in ‘fraudulent test kits,’ agency says”

        And, of course, the story is about the FDA cracking down. They are doing so because the tests being sold are not reliable. As the WAPO put it . . .

        Officials said “unscrupulous actors” have been “marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.”

        So, your response is nonsense. Your doctrinaire dislike for the government seems to impair your reading ability.

        Liked by 1 person

        1. And yet, not a single case was cited.

          If you read the NYT article, you will find the story behind the story.

          “The result has been a confusing landscape in which tests by established companies such as Abbott Laboratories, Cellex and most recently, Roche Diagnostics, are competing with unapproved tests made by unknown companies and sold by U.S. distributors with spotty track records. ”

          Guess who the 50 scientists work for. The FDA has been a tool for established Pharma corporations to suppress competition for decades. That’s how we got $600 EpiPens and $800 insulin.

          Not surprisingly all three of the Congressional Democrats who raised the issue received their highest campaign contributions from Healthcare Corporations.

          Those of you who most hate corporations invariably turn out to be their most useful tools. (Open Secrets)

          The FDA’s function is not safety or health, it is the suppression of competition.


          1. @Tabor
            Your spin is getting sillier and sillier. As Mr. Roberts might say – so what? So what if this particular story did not cite the specific cases of a malfunctioning test kits that provoked the FDA’s action?

            The point of this story is clear and one that you are constitutionally blind and deaf to. Without FDA regulation and oversight, the “free market” almost immediately began peddling garbage to make a quick buck. And that it would do so, was entirely predictable.

            Liked by 1 person

          2. So, if inaccurate tests by established suppliers your doctor would trust were rampant, you should find it easy to show proof.

            If you can’t, then what purpose does the FDA serve other than suppression of competition.


          3. How would your doctor know? Unless the kits are tested first, the doctor is not going to keep a data base of his own patients who might get sick and die two weeks later.

            If Big Pharma and the FDA are in cahoots, which is not out of the question, then Trump needs to stop it. Draining the swamp for our national health and security is a lot more important than allowing coal effluent in our waters so mines could make more money.

            Liked by 3 people

          4. Big Pharma and the FDA have been in cahoots a long time. But absent an emergency, the FDA is pretty much untouchable. It has a huge constituency and more monetary influence than anyone but the trial lawyers.


          5. Let me see if I understand what you are saying.

            The FDA is suppressing competition because they are trying to vet out faulty test kits?

            So the solution is to let your doctor pick and choose among hundreds of kits, untested and unverified, because over time, the body count will tell us whose tests are reliable.

            You don’t really mean that?

            Liked by 2 people

          6. No, you don’t understand at all.

            The FDA, which thoroughly botched the initial testing using the CDC as a single supplier, is now going to subject serology tests to the same maze of regulation, delaying the upstart competitors by months at the least, giving a few established cronies control of the market till then.

            When you were in business, did you not have suppliers you trusted or did you start every order like you were new to the marketplace?

            When you decided to try new suppliers, did you not seek reviews in your trade journals?

            Do you think your doctor is an idiot?


          7. @Tabor

            “if inaccurate tests by established suppliers your doctor would trust ”

            Care to try to narrow the terms of the discussion any further? Your attempt to “gerrymander” the issue with artificial lines only shows that you do not really have the evidence from the real world supporting your a priori belief that markets always do the best job possible.

            BTW, you casually refer to “your doctor” as the agent to ensure the safety and effectiveness of the medical products you consume, but at least 1/4th of non-senior adults (and their children) do not have a doctor. And, of course, some percentage of doctors willingly push snake oil themselves to make a quick and easy buck.

            Liked by 2 people

  1. For the umpteenth time, let your doctor prescribe your tests, don’t order them on Amazon.

    Your doctor knows which labs are reliable, and if a bad patch slips by, he will learn about it and let you know you need to be retested.

    Your doctor is a better gatekeeper for you than the FDA


    1. @Tabor

      I have no intention of personally buying a test of unknown quality. That would be dumb. But in this country there are 63 million people who voted for Trump and the “market” knows that. And does not hesitate to sell snake oil to anyone who will buy it.

      Liked by 2 people

      1. @Murphy

        You touch on something that continues to bother me. The majority of the trump cult are massively ignorant and not very bright. “They” will follow directions/suggestions that make little sense and are potentially harmful.

        As much as I may want to simply watch as the herd is thinned I can’t do so in good conscience. While stupid can’t be “fixed” it also can’t be blamed.

        What continues to fry my ass are the smart cultist and non-cultist excusing Trump’s hateful actions and behavior to abuse the blind masses for their own ends.

        Liked by 2 people

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