Discredited: CDC SARS-CoV-2/COVID-19 Testing & Isolation Claims
A few days ago I provided critical comments on a publication from Australia (University of Melbourne) which claimed isolation and identification of SARS-CoV-2 virus [1]. I suggested that claims were not supported by scientific evidence and logic.
The present article critically evaluates a similar claim from America’s Center for Disease Control (CDC) in a publication [2] entitled:
“Severe Acute Respiratory Syndrome Coronavirus 2 from Patient with Coronavirus Disease, United States”. [ CDC-publication]
The patient case report for this (above mentioned) study is detailed in a separate publication [3], and is considered here first before we moved to the study itself.
Case Report – COVID-19 Diagnosis
A 35-year-old man who had recently returned from China presented to a clinic in Washington State with a 4-day history of cough and subjective fever. The patient visited the hospital voluntarily after hearing of a health alert over an alleged novel coronavirus outbreak in China apparently with similar symptoms to his own.
The medical examination indicated: body temperature (37.2°C); blood pressure 134/87 mm Hg; oxygen saturation 96%; chest radiography showed no abnormalities. CDC staff decided to test the patient for 2019-nCoV (subsequently renamed SARS-CoV-2) based on current CDC “persons under investigation” case definitions. The patient was discharged from the hospital, but was later called back as his PCR test returned a positive reading.
Treatment during this time was largely supportive. The patient received, as needed, 650 mg of acetaminophen every 4 hours and 600 mg of ibuprofen every 6 hours. He also received 600 mg of guaifenesin for his continued cough and approximately 6 liters of normal saline over the first 6 days of hospitalization.
In view of the potential for hospital-acquired pneumonia, treatment with vancomycin (a 1750-mg loading dose followed by 1 g administered intravenously every 8 hours) and cefepime (administered intravenously every 8 hours) was begun.
The CDC asserted that the patient’s nasopharyngeal and oropharyngeal swabs tested positive for SARS-CoV-2 via rRT-PCR assay. The stool and both respiratory specimens also tested positive by rRT-PCR for SARS-CoV-2, whereas the serum remained negative.
Treatment with intravenous remdesivir (a novel nucleotide analogue prodrug) was begun on the evening of day 7, and no adverse events were observed in association with the infusion. Vancomycin was discontinued on the evening of day 7, and cefepime was discontinued the following day.
On hospital day 8 (illness day 12), the patient’s clinical condition improved. Supplemental oxygen was discontinued, and his oxygen saturation values improved to 94 – 96% while he was breathing ambient air. The previous bilateral lower-lobe rales were no longer present. His appetite improved, and he was asymptomatic aside from intermittent dry cough and rhinorrhea. He was afebrile, and all symptoms have resolved with the exception of his cough, which was decreasing in severity.
Considering the case history, it is not clear as to why the patient was subjected to an rRT-PCR test for SARS-CoV-2 when he was exhibiting what would normally be diagnosed as a mild flu and which would therefore be treatable with antibiotics (as per Australian response). Nevertheless because the rRT-PCR test came out positive the assumption that the patient had SARS-CoV-2 prevailed leading to the antiviral drug, remdesivir was (accordingly) administered.
The fundamental error here is that the patient should not have been given an rRT-PCR test for establishing presence of the SARS-CoV-2 and this is because the rRT-PCR test is not a validated test, and cannot be validated without an independently extracted physical reference sample of the virus, which has not been obtained to date. From a scientific view point, and with regard to the matter at hand, no assay can be valid without an independently verified physical reference sample. Therefore the diagnosis, and the associated claim, that the patient had SARS-CoV-2 and its associated infection/disease (COVID-19), is necessarily false.
CDC-publication
It would be safe to assume that the authorities/experts are aware the shortcoming of the ‘PCR dialogistic process’, and (accordingly) attempt to overcome this with convoluted logic which runs as follows:
“As no physical sample of the virus is available, let us ‘create’ the virus from RNA found in the patient’s swab samples and which we presume to be RNA from SARS-CoV-2 virus.”
And as if this were not bad enough, there is additional problem consisting of the fact that the DNA resulting from such creativity is not the actual virus itself but merely a virus marker which is commonly, but wrongly, referred to as the virus.
To clarify, rRT-PCR never determines a virus but only a DNA (marker) of the virus. Moreover, PCR test does not even determine actual biological DNA from the swab samples, because it is almost invariably present in extremely small amounts which must be multiplied millions of times in order to be detected. There is therefore no definitive link between the RNA/DNA in the mucus swab and the purported virus.
In short, one cannot definitively establish the presence of a virus by simply assuming that a particular RNA/DNA strand relates to a certain patient’s symptoms, but must physically isolate the virus as a whole, which will then provide us measurable quantities of DNA.
PCR is therefore not a valid diagnostic test but a simply a technique for manufacturing multiple (millions and billions) copies of DNA initially synthesized via a RNA primer, the resulting in measurable quantity then being used to ‘confirm’ the presence of that DNA via standard analytical chemistry tests.
The limits of the technique with regard to diagnostic accuracy are well documented, and Dr. Kary Mullis (photo, above), Nobel Laureate and inventor of the PCR technique highlighted this on several occasions. Hence, PCR is often not recommended, or at least should not be relied upon, for diagnostic purposes.
Parallel to producing multiple copies of DNA via the PCR technique, the CDC also used swab samples to inoculate cell culture to produce multiple copies of the (supposed) virus. This (later) production was also monitored using the PCR technique. That is, the process involve: (1) creating multiple replicate copies of the alleged virus DNA via the PCR technique; (2) creating multiple copies of the alleged virus in a culture/media/soup from the swab sample.
The study asserts that; (1) electron microscope images of spherical particles with spikes are an indication of the presence of SARS-CoV-2 virus; (2) observed DNA from the culture containing the spherical particles is similar to that of other corona viruses (detected with PCR-technique and evaluated with computer-generated modelling) and is assumed to be associated with SARS-CoV-2.
This kind of “confirmation” treats the culture/media/soup as though it were the virus itself, which would be like saying that sugar molasses is pure sugar! This is positive (mind-set) thinking not science: the analysis should have instead culminated in the isolation of the actual virus particles themselves, which is the standard procedure for confirming the existence of any virus, its link to disease and its clinical symptoms.
Therefore, as it stands now the publication does not provide any evidence that the SARS-CoV-2 virus has been positively identified.
Further, the question remains as to the basis upon which the SARS-CoV-2 is considered linked to the disease COVID-19. Just what actually is a COVID-19 disease? What are its specific symptoms and clinical measurable parameters? The case study as well as the CDC-publication reveals nothing in this regard, but rather, it would appear that a trendy PCR digital testing regime has substituted for real, ‘boring’ empirical science.
And there are several associated claims of similar dubious merit:
(1) SARS-CoV-2 is contagious;
(2) SARS-CoV-2 is 5 or 10 times deadlier than the common flu virus;
(3) face-masks provide protection from the virus;
(4) social distancing protects the public by stopping or reducing the spread of the virus;
(5) washing hands or exposed skin surfaces provides protection from the virus;
(6) lockdowns (partial or full) help reduce the spread of the virus;
(7) a significant increase in positive test results (“cases”) shows a wide spread of the SARS-CoV-2 virus;
(8) vaccines are under development, with various time schedules for availability, to protect patients/public from the SARS-CoV-2 virus.
In summary, the resultant declaration by the CDC of the presence of SARS-CoV-2 in the USA was based on flawed (PCR) technique. This declaration was then further assumed confirmed by electron microscopic images of “virus-like” sphere-with-spikes particles in cell lysate or cell culture.
No effort was made to isolate, identify, and characterise the particles from culture media to confirm that the particles were indeed SARS-CoV-2 and whether or not they might have represented other viruses previously catalogued.
It is quite clear that the analysis was not submitted to the rigours of empirically-based science.
Experts and authorities are requested to reconsider their views with regard to the scientific method in declaring the presence of the virus, its link to any disease and its spread. The science of analytical chemistry would state that there is currently no evidence available in support of the current claims and measures regarding the virus SARS-CoV-2 and COVID-19 narrative.
References:
[1] http://www.drug-dissolution-testing.com/?p=3533
[2] https://wwwnc.cdc.gov/eid/article/26/6/20-0516_article
[3] https://www.nejm.org/doi/full/10.1056/NEJMoa2001191
For further information please visit www.drug-dissolution-testing.com)or directly contacting the author at [email protected].
About the author: Saeed A Qureshi PhD gained extensive (30+ year) experience in conducting hands-on and multi-disciplinary laboratory research in pharmaceutical areas for regulatory assessment purposes while working with Health Canada.
He is an internationally recognised expert in the areas of pharmacokinetics, biopharmaceutics, drug dissolution testing, analytical chemistry as related to characterization of pharmaceuticals, in particular, based on in vitro (dissolution) and bioavailability/bioequivalence (humans and animals) assessments.
At present, Dr. Qureshi provides teaching, training and consulting services, in the area of his expertise as noted above, for improved pharmaceutical products development and assessments.
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Tom O
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I am a bit confused in that I have always had the impression from these studies that virus cells were visible in an electron microscope mostly as a 2D representation, mentioned here as a spherical body with spikes, and that “particles” were pieces broken loose, if you will from the virus cell, presumably as it’s integrity is compromised. Yet this article refers to spherical particles with spikes, and also uses the term virus particles as if it is referring to the whole virus as well as if it is referring to strands. Or is it just today there is more bone density between my ears than usual?
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JaKo
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Hi Tom O,
I think what you called the “virus cells” are virions, also called virus particles ~”units” of a virus.
What you referred to as “particles” were not to virions, but RNA/DNA fragments (as bits and pieces of a genetic material, possibly of viral/or even corona-viral origin and/or of something entirely different.
What Dr. Qureshi demonstrated in this article is that CDC did not isolate this chimeral virus yet. As said many times before, nobody seems to have isolated this virus yet, and, I would just add, to be more carefull, “the knowledge of this is not, or not admitted to be, in public domain.”
There are many nice electron microscope pictures of corona viruses; however, to get from a picture to isolation and culturing and, eventually, to genetic sequencing or, more importantly, to satisfy Koch postulates of a disease causality isn’t a monkey business…
Cheers, JaKo
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Dean Michael Jackson
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Nevertheless because the rRT-PCR test came out positive…”
PCR cannot ‘positive’ or ‘negative’ anything! It can ONLY replicate. How many times does this simple fact have to be repeated?
PCR is an amplification tool, it can’t detect/identify. Period.
Cycle threshold (CT) is not only arbitrary, it’s meaningless, and an abuse of Kary Mullis’ amplification tool. CT is merely an arbitrary number of amplifications above an equally arbitrary lower number of amplifications referred to as “background level”…
https://www.wvdl.wisc.edu/wp-content/uploads/2013/01/WVDL.Info_.PCR_Ct_Values1.pdf
The PCR amplifies nucleotide sequences exponentially…
https://www.khanacademy.org/science/ap-biology/gene-expression-and-regulation/biotechnology/a/polymerase-chain-reaction-pcr
…up to approximately 40 amplifications,[1] therefore any differences between the CT level and background level are meaningless. A CT of 21x merely means there were 21 amplifications. A CT of 30 has 30 amplifications. A CT of 21x simply means the nucleotide sequence was amplified 21 times, not that there is “strong positive reactions indicative of abundant target nucleic acid”…
https://www.wvdl.wisc.edu/wp-content/uploads/2013/01/WVDL.Info_.PCR_Ct_Values1.pdf
When anyone mentions “CT”, they have self-identified as Marxist societal sabotage operatives.
At my blog, read the articles…
‘House of Cards: The Collapse of the ‘Collapse’ of the USSR’
‘Playing Hide And Seek In Yugoslavia’
Then read the article, ‘The Marxist Co-Option Of History And The Use Of The Scissors Strategy To Manipulate History Towards The Goal Of Marxist Liberation’
Solution
The West will form new political parties where candidates are vetted for Marxist ideology/blackmail, the use of the polygraph to be an important tool for such vetting. Then the West can finally liberate the globe of vanguard Communism.
My blog…
https://djdnotice.blogspot.com/2018/09/d-notice-articles-article-55-7418.html
[1] Thereafter amplification growth is less than exponential.
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Charles Higley
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“From a scientific view point, and with regard to the matter at hand, no assay can be valid without an independently verified physical reference sample. ”
A big problem here is that, even with an isolated pure culture of the virus, is remains to be shown that it is the virus causing Covid-19 syndrome. A patient can have more than one virus at a time and the Covid-19 virus has to be present in all of a group of patients regardless of other viruses they might also have. The real science here has not been done and this virus remains a myth. The wide and varied symptoms likely derive from a mixture of flu season viruses, particularly when they decided to stop testing for influenza and assuming all symptoms were from this purported virus.
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John the First
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To quote from this same site:
“Over the next 15 weeks, the woman would be tested for COVID-19 more than a dozen times. The virus was detected in her upper respiratory tract for 105 days; and infectious virus particles — meaning they were capable of spreading the disease — were detected for at least 70 days. Specifically, the researchers were able to isolate the virus from the patient’s samples, and grow it in a lab. They were even able to capture images of the virus using scanning and transmission electron microscopy.”
https://principia-scientific.com/woman-sheds-coronavirus-for-70-days-without-symptoms/
So, freedom of different opinion, but these articles are not about opinions..
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Saeed Qureshi
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It appears that authors of the study you mentioned followed the same protocol/practice as that the CDC and Australian laboratories I mentioned in my article. That is “creating” the virus from swab samples and establishing its presence and associated DNA using PCR testing. In addition, the electron microscopy images are also from the isolates (not of the isolated virus) similar to the above mentioned studies. Therefore, conclusion drawn in this study should suffer the same shortcomings as those of the Australian and CDC studies i.e. virus (SARS-CoV-2) has neither been positively identified nor its link to the disease (COVID) been established.
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Scott
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Looks like they are claiming they can automate it.
https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(20)30570-X/fulltext?fbclid=IwAR267QuZyVYh2M2TSaKI3ugkc1ira8bSyeXZGk1xiHHIZR1qpW0-_fMBtes
But I think they are confirming what you have stated at least in part.
Only a few laboratories routinely isolate the virus, which is because the current co-culture strategy is highly time-consuming and requires a biosafety level 3 laboratory. This work aimed to develop a new high-throughput isolation strategy using novel technologies for rapid and automated isolation of SARS-CoV-2.
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Saeed Qureshi
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Thanks for sharing your thoughts and providing the link.
However, conclusion of my article will remain unchanged i.e. “In summary, the resultant declaration by the CDC of the presence of SARS-CoV-2 in the USA was based on flawed (PCR) technique. This declaration was then further assumed confirmed by electron microscopic images of “virus-like” sphere-with spikes particles in cell lysate or cell culture. No effort was made to isolate, identify, and characterise the particles from culture media to confirm that the particles were indeed SARS-CoV2 and whether or not they might have represented other viruses previously catalogued.”
The described article started by stating “A novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is responsible for the current coronavirus disease 2019 global pandemic.” There is no evidence in support of this statement. There is no isolation of the virus. CDC and Australian studies also assume this and then build their case on this false assumption. This study is also based on known flawed-PCR testing and microscopic images of cell damage. Automation (of images reading) is irrelevant for the identification purpose. Identification can only be done by physically isolating the virus.
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John the First
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As a layman, I wonder, if you have isolated a virus, how do you determine whether it is the cause of this or that disease?
John the First
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Thanks for the responses so far by the way.
Saeed Qureshi
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This is not my area of expertise, so I invite others to provide some specifics in this respect relating to physiological, clinical, and/or pathologically endpoints.
From my perspective, however, first and the foremost important thing is that the test for the detection and monitoring the virus, or its marker, must be validated based of accepted principles of analytical science/chemistry. This requires that the test must meet the following four parameters: (1) accuracy; (2) precision; (3) specificity; (4) references used to validate the method. This is unfortunately missing at present and needs to be addressed.
The disease i.e. its SPECIFIC symptoms (physiological, clinical, and/or pathologically deviations from norm), should be linked to the presence of the virus, or its marker, using the validated tests. Medical and related disciplines should consider acquiring appropriate knowledge and expertise of analytical science/chemistry. My recent blog post may be useful in this regard (http://www.drug-dissolution-testing.com/?p=3557).
thebigbus
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Agree wholeheartedly, until the end (just a quibble).
Finding particles in a cell culture to “prove” the thing you are already assuming (SARS COV 2) is fallacious.
To do things SCIENTIFICALLY, one must first isolate particles from human beings that are THOUGHT to possibly be the cause of disease, and then do proper experiments to show such a thing (experiments that must also be physiologically relevant).
This is not attempted in virology.
You MUST have an isolated independent variable (particles from humans), and you must have a valid dependent variable.
Showing cytopathic effect in a 2D monolayer aneuploid cell line is not a valid DV. It is NOT what we are observing in nature. And then finding particles in said culture and saying “that’s the virus”, is asserting the consequent and question begging.
There is no science being done in virology and I’m appalled at academia for not pointing this out.
Perhaps I’m a stickler for definitions, but “science” used to have a well defined meaning – meaning the method.
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John Blaid
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Please check out my research summary where I provide 40 responses to FOIA requests done to 34 institutions in various countries like England, Scotland, Wales, Ireland, Canada, New Zealand, Australia, Denmark, US(CDC) and European CDC that shows the lack of evidence for the existence of the “virus”. It also includes the scientific evidence regarding the faulty PCR and “antibody” tests and the false science behind “antibodies” and what these proteins actually do in contrast to what we have been taught and much much more.
Research summary and debunk regarding the existence of “SARS-CoV-2” and “COVID-19”
https://steemit.com/health/@johnblaid/research-summary-and-debunk-regarding-the-existence-of-sars-cov-2-and-covid-19
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