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June 20, 2020 Washington Post: federal investigation confirms earlier findings:
June 20, 2020, “CDC coronavirus test kits were likely contaminated, federal review confirms," Washington Post, David Willman
“The test kits for detecting the nation’s earliest cases of the novel coronavirus failed because of “likely” contamination at the Centers for Disease Control and Prevention, whose scientists did not thoroughly check the kits despite “anomalies” during manufacturing, according to a new federal review.
The review, conducted by two Department of Health and Human Services lawyers, also said there was “time pressure’’ at the CDC to launch testing, and “lab practices that may have been insufficient to prevent the risk of contamination.’’ The lawyers, from the department’s general counsel’s office, were not named.
Neither the review, released late Friday, nor an accompanying statement from President Trump’s chief spokesman at HHS assigned blame to any CDC scientist or official by name.
The review is the first confirmation by the Trump administration that the original test kits were likely contaminated, and that the problem appeared to have occurred in late January within the CDC’s headquarters in Atlanta. In general, HHS has defended the administration’s efforts to counter the pandemic.
The three-page review also acknowledged that, after weeks of delay, the likely contamination ultimately prompted the CDC to jettison a problematic component of the test kit. The component was intended to detect coronavirus strains other than the one that causes covid-19….
The Washington Post reported on April 18 that the test kits had generated false-positive results — caused by the CDC’s contamination —at 24 of the first 26 public health labs that tried them out before analyzing samples from actual patients. The Post also reported that an examination by the Food and Drug Administration had concluded that the tests failed because of substandard manufacturing practices and that the CDC violated its own laboratory protocol in making the kits.
The false positives arose during testing of “negative control’’ samples that contained highly purified water and no genetic material. That aspect of testing was essential to confirm that results would be reliable and not skewed by contamination.
A spokesman for the CDC did not immediately respond to a request for comment on the HHS review. The review was first reported Friday by Sinclair Broadcast Group.
The CDC’s failure with the test added many weeks of delays to the rollout of widespread testing and hampered efforts by state and local public health labs to minimize harm before the coronavirus became widely established in the United States.
The review was based on the HHS lawyers’ interviews “with nine CDC employees and contractors who were involved in the production of the test kits.’’ The lawyers also spoke with Timothy Stenzel, a top FDA official regulating diagnostic devices used for medical treatment, and “one other FDA scientist in a consulting capacity,’’ according to the review.
The review identified several CDC labs involved with making the test kits. It said it was “possible’’ that contamination occurred during production of materials for the kits performed by the Biotechnology Core Facility Branch, known as the core lab.
But the review noted that the core lab “took extreme precautionary measures…to minimize any risk of contamination.’’ The contamination “most likely’’ occurred in CDC’s Respiratory Virus Diagnostic Lab, during its processing and testing of the materials produced by the core lab, the review said.
“It was at this stage of the manufacture, when the bulk reagent materials for the test kits were processed and tested at [the respiratory virus lab], that they were most likely exposed to positive control material,’’ the review said.
According to the review, the respiratory lab “had already made multiple uses of positive control material at the time bulk test kit reagents were being handled, increasing the opportunities for contamination.’’
The review also said that “a number of CDC interviewees and Dr. Stenzel of FDA described lab practices that may have been insufficient to prevent the risk of contamination, though it is likely that time pressure also contributed.’’
There were signs of trouble before the tests were sent to the public health labs, the review found.
Before they were shipped out, the test kits “began showing issues with negative controls showing positive results,” the review said. However, the kits were not vetted in advance with standard quality control and quality assurance, or “QC/QA,’’ procedures, according to the review.
“It appears that time pressure to ship test kits out quickly — and before QC had been conducted on them — might have compromised sufficient QC/QA to identify certain anomalies in data and realize the possibility of contamination before shipment,’’ the review said.
Asked by email if disciplinary action has been taken or is contemplated against any CDC employee involved with the test kits, an HHS spokeswoman declined to comment.
Present and former federal scientists experienced with infectious-disease testing and a congressman who has sought answers about what went wrong at the CDC said in interviews that sending out the test kits without adequate quality control was indefensible.
“They should have waited,’’ said Stephen A. Morse, a retired senior CDC microbiologist.
Rep. Raja Krishnamoorthi, (D-Ill.), who has praised coronavirus testing efforts in South Korea, Taiwan and other countries, said, “We have to look back at those weeks in February as having been the critical period in which the [U.S.] government’s response totally failed.’’
The top HHS spokesman, Assistant Secretary for Public Affairs Michael Caputo, said in his statement that “we never had a backlog of tests in this country.’’ In subsequent responses to The Post on Saturday, HHS touted “the Trump Administration’s historic coronavirus response.’’
A separate audit of the CDC’s handling of the test kits remains underway by the HHS Office of Inspector General and is not expected to be completed until 2021.”
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Added: CDC test contamination reported 4/18/2020 by NY Times: FDA official investigating CDC “found an astonishing lack of expertise in commercial manufacturing and learned that nobody was in charge of the entire process.”…CDC tests sent to labs around the country in early February were themselves “contaminated with the coronavirus” causing a month’s delay in early US testing. “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….Forced to suspend the launch of a nationwide detection program for the coronavirus for a month, …the country lost ground….“It was just tragic.…All that time when we were sitting there waiting,...here we were at one of the most critical junctures in public health history, and the biggest tool in our toolbox was missing."…Mr. Becker said that public health laboratories started receiving the C.D.C. kits on Feb. 7, and by the next day members were already calling him to report that the test was not working accurately.”
"The number of confirmed cases means nothing because most infections do not result in "cases," and hence that the real number for infections is surely higher, possibly by an order of magnitude. Also, the counting of deaths from COVID-19 is being revised downward because many of these deaths result from other causes and are attributed to COVID-19 only because the person happens also to have tested positive....The real lethality rate is a fraction of one percent. That is why the curves Fauci, the medical establishment, the media, and Democratic governors cite for keeping the country shut down mean nothing....Since the Ides of March, President Trump has placed himself on a path that the fundamentals suggest leads to political suicide. He did this by surrendering to the ruling class—Drs. Anthony Fauci, Deborah Birx, et al, not to mention House Speaker Nancy Pelosi (D-Calif.)—his judgment on whether and for how long, and how the country should be shut down. This is of the greatest concern to the American people in general and to his voters in particular. By giving his imprimatur while suggesting that he is acting against his own better judgment, he fulfills the dictionary definition of tragedy."...4/7/20, Angelo Codevilla
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4/18/20, “C.D.C. Labs Were Contaminated, Delaying Coronavirus Testing, Officials Say,” NY Times, Sheila Kaplan (page A5, Sun., 4/19 print ed.)
“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.
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.
The F.D.A. confirmed its conclusions late this week after several media outlets requested public disclosure of its inquiry, which assuredly is part of a larger federal investigation into the C.D.C. lab irregularities by the Department of Health and Human Services.
Forced to suspend the launch of a nationwide detection program for the coronavirus for a month, the C.D.C. lost credibility as the nation’s leading public health agency and the country lost ground in ways that continue to haunt grieving families, the sick and the worried well from one state to the next.
[Image: “For his contributions, Fauci was awarded the Presidential Medal of Freedom by Bush in June 2008,” AFP/Getty]
To this day, the C.D.C.’s singular failure symbolizes how unprepared the federal government was in the early days to combat a fast-spreading outbreak of a new virus and it also highlights the glaring inability at the onset to establish a systematic testing policy that would have revealed the still unknown rates of infection in many regions of the country.…
While President Trump and other members of his administration assert almost daily that the U.S. testing capacity is greater than anywhere else in the world, many public health officials and epidemiologists have lamented the lack of consistent, reliable testing across the country.…
Dr. Robert R. Redfield, the director of the C.D.C., and other health experts have long suggested that contamination in the labs might have been the culprit. But even as several officials at the F.D.A. late this week cited contamination as the cause, a spokesman for the C.D.C., Benjamin Haynes, asserted that it was still just a possibility and that the agency was still awaiting the formal findings of H.H.S.
In a statement, however,
he acknowledged that the agency’s quality control measures were
insufficient during the coronavirus test development. Since then, he
said, “C.D.C. implemented enhanced quality control to address the issue and will be assessing the issue moving forward.”
Initially, the C.D.C. was responsible for creating a coronavirus test that state and local public health agencies could use to diagnose Covid-19 in people, and then isolate them to prevent the spread of the disease.
“It was just tragic,” said Scott Becker, executive director of the Association of Public Health Laboratories. “All that time when we were sitting there waiting, I really felt like, here we were at one of the most critical junctures in public health history, and the biggest tool in our toolbox was missing.”
Mr. Becker said that public health laboratories started receiving the C.D.C. kits on Feb. 7, and by the next day members were already calling him to report that the test was not working accurately. He alerted both the C.D.C. and the F.D.A., which regulates medical devices, including laboratory tests.
“This is consistent with what we said was plausible when we found the problem at the beginning,” Mr. Becker said. “When we found the problem, it seemed to our community that it was a contamination issue that would cause a problem to this extent.”
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.
More than two months later, nearly
700,000 Americans have [allegedly] become infected and close to
[allegedly] 40,000 have died”…
“Confirmed and Probable Counts
As of April 14, 2020, CDC case counts and death counts include both confirmed and probable cases and deaths. This change was made to reflect an interim COVID-19 position statement issued by the Council for State and Territorial Epidemiologists on April 5, 2020. The position statement included a case definition and made COVID-19 a nationally notifiable disease. Nationally notifiable disease cases are voluntarily reported to CDC by jurisdictions.
A confirmed case or death is defined by meeting confirmatory laboratory evidence for COVID-19.
A probable case or death is defined by one of the following:
*Meeting clinical criteria AND epidemiologic evidence with no confirmatory laboratory testing performed for COVID-19
*Meeting presumptive laboratory evidence AND either clinical criteria OR epidemiologic evidence
*Meeting vital records criteria with no confirmatory laboratory testing performed for COVID19
Not all jurisdictions report confirmed and probable cases and deaths to CDC. When not available to CDC, it is noted as N/A.
Accuracy of Data
CDC does not know the exact number of COVID-19 illnesses, hospitalizations, and deaths for a variety of reasons. COVID-19 can cause mild illness, symptoms might not appear immediately, there are delays in reporting and testing, not everyone who is infected gets tested or seeks medical care, and there may be differences in how jurisdictions confirm numbers.”].
[Ed. note: NY City rations testing, requests that only most severe cases take test as of 4/19/20: “The data presented below reflect the most recent information collected about people who have tested positive for COVID-19 in NYC. We are discouraging people with mild to moderate symptoms from being tested at this time, so the data primarily represent people with more severe illness.”…]
(continuing): “and it can take days before doctors and patients receive results. Many infectious disease and public health experts say testing is nowhere near widespread enough to reopen the country or return to some semblance of normal.”
[Images above were added by this blog]
Added: Pathetic British Empire falls for two huge “test” scams:
In at least two “test” scams, US “ally” the British Empire spent millions on virus laden “tests” which added weeks to imprisonment of healthy families. Articles from March and April 2020: 3/30/20, UK “Coronavirus testing effort hampered by kits contaminated with Covid-19,” UK Telegraph, Bill Gardner, Harry Yorke
“UK test kits contaminated, weeks added to lockdown as new kits will take weeks.”
Tests ordered from “overseas:” “One of the suppliers–the Luxembourg-based firm Eurofins–sent an email on Monday morning to government laboratories in the UK warning that a delivery of key components…had been contaminated with coronavirus and would be delayed. The firm admitted there had been “an issue” and insisted other private providers had suffered the same problem.”…
Who needs bombs? Uncheckable, ever changing numbers have replaced bombs as weapons of mass destruction. As soon as ANY number gets the Queen’s endorsement it becomes a weapon of mass destruction since it can cause millions of healthy families around the world to be imprisoned indefinitely.
[Image: June 3, 2019, Trump and his pal the Queen during dinner at Buckingham Palace, getty] (UK Telegraph): “They added that a number of people were tested more than once, thereby resulting in the disparity between the statistics.
Government sources said the discrepancy was partly caused by hospitals not knowing at the start of each day how many people would need to be tested, and holding back enough capacity to ensure they did not run out of tests.”…
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In April 2020, falling for at least its second test scam, the British Empire paid millions to Communist China for tests that didn’t work, NY Times:
4/16/20, “U.K. Paid $20 Million for New Coronavirus Tests. They Didn’t Work.” NY Times, David D. Kirkpatrick, Jane Bradley, London…(Print ed., 4/, Section A, Page 1, NY ed., headline: “Britain Bets On Test Kits, And It Loses.”)
“Facing a global scramble for materials, British officials bought millions of unproven kits from China in a gamble that became an embarrassment.”
“The two Chinese companies were offering a risky proposition: two million home test kits said to detect antibodies for the coronavirus for at least $20 million, take it or leave it.
The asking price was high, the technology was unproven and the money had to be paid upfront. And the buyer would be required to pick up the crate loads of test kits from a facility in China.
Yet British officials took the deal, according to a senior civil servant involved, then confidently promised tests would be available at pharmacies in as little as two weeks. “As simple as a pregnancy test,” gushed Prime Minister Boris Johnson. “It has the potential to be a total game changer.”
There was one problem, however. The tests did not work.
Found to be insufficiently accurate by a laboratory at Oxford University, half a million of the tests are now gathering dust in storage. Another 1.5 million bought at a similar price from other sources have also gone unused. The fiasco has left embarrassed British officials scrambling to get back at least some of the money.”…
(Above image of the Queen added by this blog)
Added: As of April 17, 2020, only 29 people in NY City hospitals for virus:
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