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Oh, about that flawed FDA Covid-19 test . . . it may have been contaminated with the virus

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Here’s the report:

As the new coronavirus took root across America, the US Centers for Disease Control and Prevention sent states tainted test kits in early February that were themselves seeded with the virus, federal officials have confirmed.

The contamination made the tests uninterpretable, and—because testing is crucial for containment efforts—it lost the country invaluable time to get ahead of the advancing pandemic.

The CDC had been vague about what went wrong with the tests, initially only saying that “a problem in the manufacturing of one of the reagents” had led to the failure. Subsequent reporting suggested that the problem was with a negative control—that is, a part of the test meant to be free of any trace of the coronavirus as a critical reference for confirming that the test was working properly overall.

Now, according to investigation results reported by The New York Times, federal officials confirm that sloppy laboratory practices at two of three CDC labs involved in the tests’ creation led to contamination of the tests and their uninterpretable results.

That’s a real oopsie if so.

NYT adds:

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.

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.

Poor lab practices seem to be a concern surrounding this epidemic.

And, a failed test was indeed a big part of stumbling, multiplied by red tape hurdles to get other tests going. Time to connect dots. END

Comments
Of relevance to the discussion - The Economist has data on excess mortalities across several countries. There's a clear pattern of excess, even over deaths not attributed to covid-19.Bob O'H
April 22, 2020
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To me that really amounts to no data: 88 premorbidity is a statistic, to assess its importance we have to know how serious those other ailments are. Hypertension and obesity are both comorbidities found in covid19 deaths, but they are also very common in the general population and many people live quite happily with them. So the statement alone is pretty much worthless. The idea that people are "dying with" covid19 is also very hard to marry with the spikes in mortality across the globe.orthomyxo
April 21, 2020
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Ortho,
“On re-evaluation by the National Institute of Health, only 12 per cent of death certificates have shown a direct causality from coronavirus, while 88 per cent of patients who have died have at least one pre-morbidity – many had two or three,”
. . . does not constitute "no data." It highlights the difference between dying from CV19 and dying with it. Yes, this is summary percentages issued by the technical advisor who would be behind a ministerial statement. Those percentages would not be put up by such a person without what my native land calls "backative." In short, you are manifesting the gold standard fallacy. And besides, what was said is consistent with a given of decision theory: dirty, noisy, quick proxy data or summaries from reasonable source are enough for astute decision making when time is of the essence. Napoleon on the Austrians: they are always late, first with their payments and at length with their armies. KFkairosfocus
April 21, 2020
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BA, decision theory will prevail over the gold standard evidence threshold fallacy. We will recognise that nBAU gives a baseline comparison with Flu and its treatment so there is no need to give people facing a disease that can kill in 10 days, doing organ damage along the way, sugar pills in order to construct an artificial baseline. We will see evidence being belittled, dismissed and suppressed that points to 90 - 95% reduction in mortality among vulnerable groups for two credible ALTs. We will see that a US$20, outpatient oriented treatment can take pressure off the system, allowing better care for serious cases. We will see that this then allows responsible re-opening of community life and economic activity, leading to a surge in investor and consumer confidence. The lockstep globalist progessivist elites and their media mouthpieces and amplifiers will take a deserved, decisive blow to their credibility and dominance of opinion. As a result, civilisation-level trends are going to shift dramatically, starting with digitalisation of work and education. That's a Kondratiev, long wave level shift. This pandemic marks a break in history. KFkairosfocus
April 21, 2020
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So, a month ago, not the minister but an advisor and no data just this lone statement? Sounds a bit like Early on some advisor to the Italian government made a statement about comorbidities, but it was never linked to any actual data. The conclusion flies in the face of the actual mortality data tooorthomyxo
April 21, 2020
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KF
What we have is tracking the basic dynamics of sigmoids and related models well enough to guide decisions.
Well, we have that, and we also have the Jim Thibodeau's and Orthomyxo's who clinch their confirmation bias with all their might, refuse to face the obvious, and who by all appearances are content to watch the world's economy burn to the ground. I wonder which will prevail. Barry Arrington
April 21, 2020
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Orthomyxo
I think you got that factoid wrong Barry, unless you have a link?
From a March 23 article in The Telegraph:
According to Prof Walter Ricciardi, scientific adviser to Italy’s minister of health, the country’s mortality rate is far higher due to demographics - the nation has the second oldest population worldwide - and the manner in which hospitals record deaths. . . . Prof Ricciardi added that Italy’s death rate may also appear high because of how doctors record fatalities. “The way in which we code deaths in our country is very generous in the sense that all the people who die in hospitals with the coronavirus are deemed to be dying of the coronavirus. “On re-evaluation by the National Institute of Health, only 12 per cent of death certificates have shown a direct causality from coronavirus, while 88 per cent of patients who have died have at least one pre-morbidity - many had two or three,” he says.
That crashing sound you hear is your confirmation bias tumbling down around you. You have been caught out just making it up as you go in this instance. It colors everything you've said and will ever say in these pages. Barry Arrington
April 21, 2020
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@ KF ExactlyAaronS1978
April 21, 2020
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BA, we have proxies so far, really good numbers are going to require a lot of testing on antibodies and going back through statistical records then calibrating demographically. What we have is tracking the basic dynamics of sigmoids and related models well enough to guide decisions. We are seeing global peaking of wave 1, with China seeing minor onward waves, true Wave 2 is likely, come the next flu season. Damaging economic and social impacts of the lockdown are leading to early signs, pointing to a need for a managed exit from n-BAU. With the Raoult-Zelenko protocols allowing early targetted treatment of vulnerable groups on outpatient basis with 90 - 95% reduction in mortality relative to the n-BAU Flu with Complications & ventilators etc baseline, we have a reasonably plausible ALT1 and ALT2 to feed our scenario based planning exercise. The big weaknesses pivot on the polarisation of esp the US and its one-party media, which may cripple and delay moving to ALT-1 until a large wave of needless deaths shifts balance of power. The use of decision theory and sustainability thinking to counter the threat and compensate for the weakness may help shift balance of power. In particular, the gold standard fallacy must be exposed and corrected. That is, decision theory and BAU vs ALT using the n-BAU protocol as baseline shows an inductively cogent, epistemologiically relevant, ethically responsible answer to required evidence to move forward in the face of polarisation and mischaracterisation. Selective hyperskepticism has civilisation-level consequences and costs measured in blood and tears through pandemic and needless economic dislocation. We need to shift back to prudence based responsible rationality. KFkairosfocus
April 21, 2020
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I think you got that factoid wrong Barry, unless you have a link? Early on some advisor to the Italian government made a statement about comorbidities, but it was never linked to any actual data. The conclusion flies in the face of the actual mortality data tooorthomyxo
April 21, 2020
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The all cause mortality data makes it clear excess deaths outpace official covid deaths in the UK. No such data exists in the USA, but the prevalence of the disease is just to low for the "died with covid19"story to hold any weight. Just like the flu, the final estimates will come from excess mortality models, but I wouldn't be surprised if we were only counting 2 of 3 covid19 deaths.orthomyxo
April 21, 2020
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The reported numbers are probably considerable underestimates of the true mortality.
Except we know for a certain fact they are overstated as well, if the Italy's Minister of Health, for one, is to be believed.Barry Arrington
April 21, 2020
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@11 I actually disagree with you considerably when it comes to underestimating the mortality rate, for various reasons that I’ve already posted on before The rest of what you posted was kind of what I was thinking as well, which is why I questioned this reportAaronS1978
April 21, 2020
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The epidemic has already killed more people than a typical flu season, after the lockdowns and having only infected a few percent of the population. Deaths may well double within this peak, and could spike if the easing of suppression efforts is not carefully. The reported numbers are probably considerable underestimates of the true mortality. In most places, deaths in homes or nursing homes are not included. In the UK (the only country that I know produces this data quickly) there is a huge excess in mortality in recent weeks, much more than can be explained my registered covid deaths only: https://www.gov.uk/government/statistics/weekly-all-cause-mortality-surveillance-2019-to-2020 We are now past the end of the typical northern flu season, so I think we can exclude that as a major contributor. Oh, very few flu deaths include a positive test for influenza virus, applying similar rules to both will still show an incredible burden for covid-19orthomyxo
April 21, 2020
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https://www.oann.com/coronavirus-outbreak-in-u-s-on-track-to-be-less-severe-than-this-years-seasonal-flu/?fbclid=IwAR0dpFbWuR5DWOoK7kChGFbKzh_3oYe9PH8pVz4ejTxBnTcwt30w8bkfi5o So even I am skeptical of this but one of my friends was just posting this I just wanted to get your take on this.AaronS1978
April 21, 2020
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EG, testing kits were developed and were developed by a top flight agency. They also imposed reguloations that locked up alternatives, then managed to blow this deal. At minimum, a comparative test with other by then in-use tests would have showed up whether it was up to the mark, i.e. benchmarking. That actually underscores the point I have been making and highlights a second one, that over-regulation can be counter productive. As was noted as it happened, this also goes a long way to account for delays in getting testing moving in the US. KFkairosfocus
April 21, 2020
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I wouldn’t say the flu kills very few people, Maybe in comparison to number of infected but it still killing people in the hundreds of thousands But I will say that the over classification of death in response to this disease has greatly diminished the amount of deaths caused by flu, pneumonia, and heart disease That’s on worldometer and the CDC The problem that I have with it is we are not testing those that have passed away for whether they had Covid or not. We NEED to confirm this, we can’t and should not assume This actually distorts the numbers and we make judgements off these distortions We need to be accurate right now, and not over overcompensate and knee jerk, which I feel this is. Overcompensating with the wrong information can be entirely ineffective and very harmful And with the way others have been arguing on this site about testing being inaccurate, this is something I take some issue withAaronS1978
April 21, 2020
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AaronS1977@4, but this is the same way that we classify flu deaths. The flu itself kills very few people. It is almost always underlying conditions that the flu makes worse that kills people. If we are going to compare COVID to the flu, we have to classify it in a similar fashion.Ed George
April 21, 2020
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This is the danger with rushing a test, or a treatment, into broad use without following the ‘gold standard’ protocol for validation and verification.Ed George
April 21, 2020
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KF thank youAaronS1978
April 21, 2020
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Almost might be interesting to read as well given the fact that UD seems to have contracted the RONA https://nypost.com/2020/04/07/feds-classify-all-coronavirus-patient-deaths-as-covid-19-deaths/?fbclid=IwAR3QzT2sOJG5bp4pZRtouKBLhxRSKbL4ojveyIP-qCY8-bklym5lT6lG4KQAaronS1978
April 21, 2020
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Yup, and there is an as yet unfinished bill to pay for it. KFkairosfocus
April 21, 2020
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I hate it when that happens.daveS
April 21, 2020
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Oh, about that flawed FDA Covid-19 test . . . it may have been contaminated with the viruskairosfocus
April 21, 2020
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