I was sent this article by the author, who wished to remain anonymous. In a covering note he said:
I’m the author but my only contribution is general disapproval and putting a bit of time into collecting the data, even while I was working on it other similar articles were appearing by the day. Feel free to use or re-write, my history about big pharma is genuine (medical education) but this came about after an online spat where suddenly a microbiologist, journalist and others were copied in, so I wanted to stay anonymous and put some facts together. They offered five papers as proof of virus isolation and as I mentioned above, the Engelbrecht and Demeter article then appeared having contacted two of the five authors who admitted no purification was performed for the microscope pictures. There has been no reply yet to that conversation!
Obviously I’ve got a bias, I have chatted with some reasonable microbiologists online and they’ve got a more measured view of PCR as being imperfect but still worth using in ordinary time, but this is clearly not ordinary time and the public imagines CVD19 testing is a machine with a red or green light. Also, once in a while Trump comes out with a gem that makes me wonder, this time he said “fewer tests, fewer cases”. As far as the public goes, they probably need to see something like a PCR test in action with the operator making the same sample positive or negative at will…! Not sure if that exists.
Where the COVID19 cases come from,
Virus Isolation Myths and PCR Technology
Anonymous – June/July 2020
I work in a technical industry where calibration, testing and regulation are the norm. I can think of no comparisons where the issues described here would be acceptable in terms of evidence or risk. One maxim I ask you to keep in mind throughout is this – any scientific measurement tells you more about the instrument used than it does about the subject.
Having worked with Big Pharma clients for many years, this has informed my opinion that they are unscrupulous operators willing to defend a profitable lie to the hilt, even after prosecution. Although the term Healthcare is commonly used when describing their activities I would suggest that Disease Profit is more accurate.
I made the claim that COVID19 has yet to be confirmed as the disease from an isolated
SARS-CoV-2 virus, some replies referenced recent publications as evidence. [1][2][3][4][5] As a result of the constant media narrative and use of a spike protein illustration, the public imagines that SARS-CoV-2 has been fully isolated but in truth less than 1% of the supposed virus RNA has been remanufactured into DNA then amplified up to a billion times as part of a PCR test which is almost guaranteed to find results. Regarding what the public might reasonably expect from the evidence, a more fitting test does exist and one that would satisfy many critics – Rivers Postulates (1973) or a contemporary revision would go a long way to prove that the virus has been isolated and is responsible for the disease.
Polymerase Chain Reaction (PCR) and Virus Isolation
References to any isolation of SARS-CoV-2 invariably depend on PCR technology and yet its inventor, Dr. Kary Mullis states why this is not a suitable application.
“PCR detects a very small segment of the nucleic acid which is part of a virus itself. The specific fragment detected is determined by the somewhat arbitrary choice of DNA primers used which become the ends of the amplified fragment” [6]
“Quantitative PCR is an oxymoron. PCR is intended to identify substances qualitatively, but by its very nature is unsuited for estimating numbers. Although there is a common misimpression that the viral-load tests actually count the number of viruses in the blood, these tests cannot detect free, infectious viruses at all; they can only detect proteins that are believed, in some cases wrongly, to be unique to HIV. The tests can detect genetic sequences of viruses, but not viruses themselves.” [7]
The PCR Test
PCR is a manufacturing process and not a diagnostic tool. The PCR test does not isolate, identify or even detect any particular virus. If you are sick and have viral fragments the PCR test amplifies those sequences exponentially along with any contamination or errors from the sample. PCR testing remains the standard reference for corporate media as the means for diagnosing COVID19 but the test is not binary, it does not inherently have only two values. It uses multiple cycles of PCR with the boundary between positive and negative remaining arbitrary, but usually interpreted as infected and uninfected.
Test Equipment
All test equipment used in the referenced studies is described by the manufacturers as “For Research Use Only. Not for use in diagnostic procedures”. It also includes the following caution “Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease”.
Research Use Only (RUO) is a class of products defined by FDA regulations as “…in the laboratory research phase of development and not represented as an effective in vitro diagnostic products. Use of such tests for clinical diagnostic purposes may mislead healthcare providers and cause serious adverse health consequences to patients, who are not aware that they are being diagnosed with or treated based on the results of tests with research or investigational products.” [8]
RUO products do not need to be listed with FDA or comply with the Quality System Regulation (QSR). They can be sold without any FDA clearance or approval and in terms of a practical matter, RUO is essentially unregulated by FDA. Neither the manufacturers nor the FDA are willing to state that PCR testing is safe or effective for diagnosis.
Testing a Population with PCR
Manufacturers of PCR tests refer to the technology as “Gold Standard” in the sales literature, giving the impression that the process is standardised and regulated. One does not have to look far to find this is not the case.
“No test gives a 100% accurate result; tests need to be evaluated to determine their sensitivity and specificity, ideally by comparison with a “gold standard.” The lack of such a clear-cut “gold-standard” for COVID19 testing makes evaluation of test accuracy challenging” [9]
“The uncertainty of test reliability in the COVID19 pandemic has highlighted the imperative of standardisation in diagnostic test development, it must be part and parcel of the global response, not only for the current pandemic but also setting a precedent for novel emerging pathogens”. [10]
“…we demonstrate that elementary protocol errors, inappropriate data analysis and inadequate reporting continue to be rife and conclude that the majority of published RT qPCR data are likely to represent technical noise”. [11]
The test equipment comes with certification to support its accuracy, but from what I can see this only certifies that it behaves as advertised, the disclaimers still stand and nobody will guarantee PCR as safe for diagnosis. A review of PCR tests approved under Emergency Use Authorisation (EUA) by the FDA showed that one test each recommended that positive be considered less than 30, 31, 35, 36, 37, 38, 39 cycles, 12 recommended less than 40, and one each recommended 43 and 45. Two different test setups in two different labs, that both use the PCR cycle number 35 as a cutoff, may actually have the cutoff between negative and positive at wildly different places [12]. On this subject, Mullis stated
“If you have to go more than 40 cycles to amplify a single-copy gene, there is something seriously wrong with your PCR” [17]
Different hospitals and facilities use different cut off sensitivity standards for the test. If you cut off at 20 then everybody tested will be negative, if you cut off at 50 you might have everybody positive. If the manufacturer or the operator of PCR tests introduces a bias by design or accident there are no consequences because there is no regulation. How do the tests decide whether the sample is positive if more than one segment is required? Some tests look for only one segment, so it must be present for a positive. Other tests that look for two segments are split between those that require both to be present and those that require either one for a positive. Some tests look for three segments but only require any two to be present, while one test insisted on all three.
Under EUA, the FDA now pronounces the population infected or uninfected using equipment it would have otherwise refused to approve. In the UK, the NHS suggested that test labs perform a non-specific in-house “validation” of test kits. [13]
A recent set of EUA instructions on COVID19 testing from the FDA states “Detection of viral RNA may not indicate the presence of infectious virus or that 2019-nCoV is the causative agent for clinical symptoms. The performance of this test has not been established for monitoring treatment of 2019-nCoV infection. The performance of this test has not been established for screening of blood or blood products for the presence of 2019-nCoV. This test cannot rule out diseases caused by other bacterial or viral pathogens.” [16]
Published Data
Out of the five journal papers referenced, three use a single patient for analysis and only one has a control group. The paper A Novel Coronavirus from Patients with Pneumonia in China 2019 states “our study does not fulfil Koch’s Postulates”.[1] Even as an observer it is obvious that Koch’s Postulates are outdated for viral research hence the previous reference to River’s Postulates. In combination with the other methods used River’s Postulates would be a significant advance towards proof.
The authors of this paper were contacted by researchers Engelbrecht and Demeter who asked if the Electron Microscope pictures show purified viruses. A reply from author Wenjie Tan states “We show an image of sedimented virus particles, not purified ones”[18]
The same question was put to the authors of Identification of Coronavirus Isolated from a Patient in Korea with COVID-19 [2] and author Myung-Guk-Han replied “We could not estimate the degree of purification because we do not purify and concentrate the virus cultured in cells” [18]. Other replies to this question from similar papers included “It is not purified virus.” and “We did not obtain an electron micrograph showing the degree of purification” [18]
The Australian study contains the following;
“One unresolved question is whether patients who are clinically stable and deemed fit to be discharged from hospital but have PCR-detectable virus are infectious, or whether this indicates only the persistence of non-infectious, residual viral RNA.”[4]
No steps appear to have been taken to prove that a healthy population does not also have the residual viral RNA in question. A study published in The Lancet states “…we did not perform tests for detecting infectious virus in blood”. [14] All of the studies fail to screen out the exact contamination and technical noise critics claim is being mistaken for a virus and the authors admit this freely.
Each paper depends on PCR testing methods for primary diagnosis and all use different target portions and cutoff limits while the phrase “in accordance with manufacturer instructions” is omnipresent. Given that all equipment used falls short of FDA approval, remaining in the category of not for diagnostic use this seems incongruous from every angle.
PCR Market Value
The PCR market size is projected to be $8.5 billion by 2026 and the industry is positioning itself to exploit emerging pandemics by selling tests to governments. [15] Should the technology be proved to be the unreliable fraud that critics claim then I do not expect the PCR industry or media to ever admit this. While it remains unregulated this sector has the ability to generate a pandemic out of nothing or cover one up. It can produce any data you like and every part of the process during the COVID19 scare has been arbitrary, unregulated and without consequence.
Summary
COVID19 testing relies on a process described as unfit for purpose by the inventor. The risks from contamination and lack of screening coupled with arbitrary methods of diagnosis are overlooked in a unified group-think from the industry. Even putting those concerns aside, had there been any standards in place then the global infection data would still be far more robust than its current junk status.
The evidence base could hardly be less reliable and it certainly falls short of any proof that a SARS-CoV-2 virus has been isolated using PCR technology. If we include purified as part of the isolated definition then the result becomes a categorical negative, SARS-CoV-2 has never been isolated or proved to cause COVID19. A machine may well have lit up after 40 cycles of amplifying potential viral RNA but that is all that may be said with any confidence. We use hundreds of these non-standardised PCR tests to produce infection data, all of which are categorised as RUO and state not to be used for diagnosis. We have no way of knowing the true number of infections because the entire data set is irrevocably corrupted.
One fact to remember is that when you test an uninfected population using PCR technology it only produces false positives. The amount of false positives depends on the myriad of erratic variables described above and interpreting this data as a pandemic or seasonal flu then swiftly departs from any science to become a matter of opinion.
References
[1] A Novel Coronavirus from Patients with Pneumonia in China, 2019 https://www.nejm.org/doi/pdf/10.1056/NEJMoa2001017
[2] Identification of Coronavirus Isolated from a Patient in Korea with COVID-19 https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC7045880/pdf/ophrp-11-3.pdf
[3] SARS Coronavirus 2 from Patient with Coronavirus Disease, United States https://wwwnc.cdc.gov/eid/article/
[4] Isolation and rapid sharing of the 2019 novel coronavirus (SARS-CoV-2) from the first patient diagnosed
with COVID-19 in Australia https://www.mja.com.au/journal/2020/212/10/isolation-and-rapid-sharing-2019-novel-coronavirus-sars-cov-2-firstpatient
[5] Molecular characterisation of SARS-CoV-2 from the first case of COVID-19 in Italy
https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(20)30170-1/fulltext
[6] http://fourwinds10.com/siterun_data/health/disease/news.php?q=1385227884
[7] http://www.virusmyth.com/aids/hiv/jlprotease.htm
[8] https://www.fda.gov/media/87374/download
[9] https://www.bmj.com/content/369/bmj.m1808
[10] https://blogs.bmj.com/bmj/2020/05/06/diagnostic-tests-for-covid-19-improving-accuracy-and-global-harmonisation/
[11] https://onlinelibrary.wiley.com/doi/full/10.1111/eci.12801
[12] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations-medical-devices
[13] https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/03/guidance-and-sop-covid-19-virus-testing-in-nhs-laboratories-v1.pdf
[14] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30183-5/fulltext
[15] https://pharmaphorum.com/partner-content/covid-19-detection-kits-market-will-touch-8-5-billion-by-2026/
[16] https://www.fda.gov/media/134922/download
[18] https://off-guardian.org/2020/06/27/covid19-pcr-tests-are-scientifically-meaningless/