Entirely glorious

Sloppy laboratory practices at the Centers for Disease Control and Prevention caused contamination that rendered the nation’s first coronavirus tests ineffective, federal officials confirmed on Saturday.

Facepalm.

Recall, these were the tests that the FDA insisted everyone used, refusing to licence any others.

Two of the three C.D.C. laboratories in Atlanta that created the coronavirus test kits violated their own manufacturing standards, resulting in the agency sending tests that did not work to nearly all of the 100 state and local public health labs, according to the Food and Drug Administration.

Early on, the F.D.A., which oversees laboratory tests, sent Dr. Timothy Stenzel, chief of in vitro diagnostics and radiological health, to the C.D.C. labs to assess the problem, several officials said. He found an astonishing lack of expertise in commercial manufacturing and learned that nobody was in charge of the entire process, they said.

Problems ranged from researchers entering and exiting the coronavirus laboratories without changing their coats, to test ingredients being assembled in the same room where researchers were working on positive coronavirus samples, officials said. Those practices made the tests sent to public health labs unusable because they were contaminated with the coronavirus, and produced some inconclusive results.

In a statement on Saturday, a spokeswoman for the F.D.A., Stephanie Caccomo, said, “C.D.C. did not manufacture its test consistent with its own protocol.”

Yep, and:

The F.D.A. concluded that C.D.C. manufacturing issues were to blame and pushed the agency to shift production to an outside firm. That company, I.D.T., accelerated production of the C.D.C. test and says no more issues were reported.

Meanwhile, the F.D.A. also came under fire for not initially allowing commercial labs like Quest and LabCorp and others to begin ramping up production of their own tests.

Yep.

12 thoughts on “Entirely glorious”

  1. I was once a lucky laddy. I wondered out loud whether I should apply for a job in the Scientific Civil Service. My mentor – a sage, middle-aged chap with a calm disposition – screamed “no! never!”.

  2. Sounds like a typical academic lab vs. industry lab thing.

    Anecdote time.

    Academic lab, we used to hand-make our own gels for measuring DNA fragment length, sequencing* and so on. It isn’t complicated, mix up various cheap benchside chemicals, steady hand with pipette, accept risk of exposure to enormous quantities of known neurotoxins**. Occasionally you couldn’t get the bubbles out or the stacker wouldn’t set, but basically idiot-proof. And about 20 minutes work to make, perhaps four ten-lane gels. And then wait for an hour or so before you can use them, during which the clever ones would do something other than watch their gels setting.

    Industry labs buy ready-made gels. They cost around eight quid each then. Guess which is more cost-effective?***

    *: No one does sequencing on gels nowadays.

    **: At one point, I had two types of cyanide on my bench. That was in the lab where people ate at the desks next to the benches.

    ***: Any bench scientist should do it a few times just so they know what the hell is happening, but trainee scientists having to do it for 3 years is as silly as trainee sushi chefs having to boil rice for 3 years.

  3. If someone gets a bad test, everyone does. The Left’s idea of Equality.

    The quality of the test is secondary.

  4. Sort of replicates the farce with PHE amd lab testing in UK,versus testing being farmed out to commercial labs in germany.
    Guess who is left looking like incompetent fools, mind you their salary & pension are still safe so we’re all in it together.

  5. salary & pension are still safe so we’re all in it together

    I wonder if the PHE palatial “campus” adjacent to the M25 will still go ahead…

    I see some “testing” is happening but little information is out about it. I wonder if PHE’s plan to relocate all available machines ( and operators) to Milton Keynes went ahead or if the original operators have been left in place and samples served up by couriers?

    There is some historical enmity between NHS and PHE – the latter having been shooed off NHS property some years ago…

  6. The CDC, FDA and PHE have all been utterly fucking useless.

    Will anything change in the future?

    Stupid question.

  7. I expect the guys running these places are loyal party members though, because that’s always worked out just fine.

  8. Meanwhile, ONS stats show that all cause deaths year to date for those 75 or older stand at 121,092. The equivilent figure for 2015 (2014-15 was a bad flu season) was 132,206.

    OK, the ONS stats are a couple of weeks behind but even so.

  9. Bloke in North Dorset

    According to yesterday’s Cato Daily Podcast the big problem with the FDA is that Congress hasn’t clearly set out its remit on the issue of testing (and other things)*. So, in normal times the FDA is quite relaxed about private companies developing and doing diagnostic testing. However when something serious comes along like this and Zicka, they step in and send out letters stopping those labs working on it. Apparently its something to do with profits, but its not clear.

    This means that there is then a liability issue which means labs have to be instructed to work on it rather than just letting the market loose.

    *From my reading and listening the FDA isn’t the only agency where this happens, which is why the Administrative State is able to runs amok:

    Dr. Michael Greve, a law professor at George Mason University School of Law, defines the current implemented administrative state of the United States as, “a power once known as ‘prerogative’—that is, the power to make binding rules without law, outside the law, or against the law, exercised by someone other than an elected legislature” (Greve). He then goes on to say, in his opinion, that this is the opposite intention of the “founders” (Greve). Basically Greve is saying all government entities (agencies) are power hungry and that Americans should stick to the US Constitution that set up safeguards against the despotism that agencies will ultimately strive for if left to their own whims, instead of acting in the best interest of the country.

  10. Greve is correct. Maybe 15 of the 615 U.S. agencies are Constitutional.

    They could advise. Enforcement is bogus. E.g., if the Feds want to suggest 1 gallon flush toilets, that’s fine. The Feds demanding 1 gallon flush toilets is tyranny. As it is arbitrary and none of their fvcking business.

  11. The Holy Constitution is rather like The Holy Bible. It gets ignored if something important arises. But otherwise it basks in a flow of claims to follow its strictures.

  12. The Holy Constitution is rather like The Holy Bible.

    Close, but it’s more that each documents strictures are enforced by who is most efficient at killing and threatening to kill. You know, like any document in existence.

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