Tuesday, February 2, 2021

The Corman-Drosten disaster puts the word end on the Covid-19 pantomime

 


On September 4 2020 while he was visiting Solihull near Birmingham, to see how the new HS2 Interchange Station development is coming along, British Prime Minister Boris Johnson said to the BBC that Covid testing at airports may give a "false sense of security", as testing on arrival would only identify 7% of virus cases.

Three weeks after such unexpected statement, on September 23 2020, the same statement was made by Dominic Raab, the British Foreign Secretary at SKY News.

At that time, beyond the astonishment for such statements, which seemed to aim at dismantling the reliability of Covid 19 testing, I couldn't understand for what reason two main representatives of the British government had publicly stated that the Covid testing was unreliable, nor why the world media haven't provided any kind of follow up to such blatant declaration.

My state of misunderstanding lasted until friday december 4, when the European medical journal Eurosurveillance has published this note with which it announced having started an internal investigation to review the content of the Corman-Drosten study they had published on January 23 2020 “Detection of 2019 novel coronavirus (2019-nCoV) by real-time PCR by Christian Drosten and Victor Corman.

Why this study is so important?

Christian Drosten and Victor Corman are the two authors of the Covid-19 diagnostic test which is adopted in the majority of private and state labs, both in Europe and in the U.S.

The Corman-Drosten is the theoretical study upon which the official Covid-19 diagnostic methodology is based. It's the diagnostic upon which all the Covid-19 official data provided by governments and media are based. Consequently it is also the legal-scientific basis of all the lockdowns and of our freedom restrictions.  

This is an extraordinary story and in order to understand it we need to start from the beginning.

Eurosurveillance is a peer-reviewed medical journal covering epidemiology, surveillance, prevention and control of communicable diseases. The journal is published by the European Centre for Disease Prevention and Control which is an independent agency of the European Union whose mission is to strengthen Europe's defences against infectious diseases

Usually a scientific study in order to be published must be peer-reviewed and this process normally takes several months of work, especially if the study deals with diagnostic methodology because the processes must be replicated and validated in the laboratory.

This is especially true when it's about the testing for a global lethal virus that hit the whole planet's population.

The Corman-Drosten study was sent from the authors to Eurosurveillance on January 21 2020, it was approved for publication on the 22nd and on January 23 was put On-line. Not just this. The Corman Drosten was immediately accepted as the standard of testing internationally, by the WHO, which began sending test kits to affected regions.

In the harrowing months that followed, amid lockdowns, economic collapse, school closures and widespread panic, few were aware of the immense problems with the paper, which tragically offered a testing method that would yield between 80 and 97 percent false positive results, due to a non existent gold standard which would be the virus itself. The emergency situation prevailed on the average level of accuracy normally required to a diagnostic methodology, especially for an epidemic event of global relevance.

In this situation of chaos, the turning point took place on November 30 2020 when the Corman-Drosten was challenged by the ICSLS (International Consortium of Scientists in Life Sciences) a team of 22 international scientists from USA, Europe and Japan who wrote this letter demanding the paper’s retraction, along with a Review Report, which is indeed a real scientific study, attached to the letter citing 10 errors in the Corman Drosten it deemed “fatal.”

The Corman-Drosten Review Report is an initiative by Pieter Borger, an expert on the molecular biology of gene expression. Several other esteemed names are associated with the paper including Dr. Michael Yeadon, former VP of Pfizer and outspoken critic of much of the so-called science beneath the WHO’s global lockdown, masking, and school shut-down measures.

Celia Farber, is an american journalist known for her oustanding reports on HIV and AIDS back in the 80s. Celia spoke to Dr. Kevin Corbett, one of the 22 authors of the Review Report that dismantled the Corman Drosten:

When Drosten developed the test, China hadn’t given them a viral isolate. They developed the test from a sequence in a gene bank. Do you see? China gave them a genetic sequence with no corresponding viral isolate. They had a code, but no body for the code. No viral morphology.”

What is “viral morphology”?

In the fish market,” he said, “it’s like giving you a few bones and saying that’s your fish. It could be any fish. Not even a skeleton. Here’s a few fragments of bones. That’s your fish. Listen, the Corman/Drosten paper, there’s nothing from a patient in it. It’s all from gene banks. and the bits of the virus sequence that weren’t there they made up. They synthetically created them to fill in the blanks. That’s what genetics is; it’s a code. So its ABBBCCDDD and you’re missing some what you think is EEE so you put it in. It’s all synthetic. You just manufacture the bits that are missing. This is the end result of the geneticization of virology. This is basically a computer virus.

But what are the implications of such an incompleteness of the primer concerning the unreliability of the Covid 19 testing?

The implications are easy to understand also from those who haven't a background in virology. In practice being the initial virus incomplete, that is, composed only by RNA fragments, the setting of the machine that does the RT-PCR cannot go beyond the detection of those fragments that compose the primer in the first place. The machine cannot invent a biological structure that it hasn't, which means that the PCR machine will classify as positive also a sample that instead of possessing the whole RNA fragment has only a fragment of the said nucleic acid.

The conclusion made by the ICSLS Review Report is that the Corman-Drosten hasn't been structured to detect the whole virus but only to detect a fragment of it, which is the one they had at their disposal. This means as we'll see later, that the machine cannot distinguish between a fragment of RNA and the whole virus. This fact also defines the testing as inadequate as a diagnostic tool for the SARS virus infections.

In an interview posted on his Twitter account Pieter Borger said: “The virus wasn’t in Europe and the paper was already finished.” then he added: “Once I heard a good comparison,” he continued. “If you go to a junkyard and you find a wheel or a hubcap from a Mercedes, and a steering wheel of a Mercedes, can you infer that you are in a Mercedes garage at that moment? If you only see those two parts? No, you can’t. You don’t know anything about it… you only know you have a steering wheel, you can find those things everywhere. In every junkyard you can find them.” He describes the RT-PCR tests as having “no relevance for the diagnosis whatsoever.”

What is the RT-PCR testing?

The RT-PCR (Reverse Transcriptions - Polymerase Chain Reaction) is a laboratory technique of molecolar biology allowing reverse transcription of RNA into DNA and amplification of specific DNA targets using polymerase chain reaction (PCR).

Normally the Polymerase Chain Reaction works with a DNA filament or a fragment of it that you want being amplified. The Reverse Transcription instead has an RNA filament or a part of it as a starting point to obtain the DNA filament, and once you obtained the DNA you go on with the amplification process.

That's why in this context, DNA is called complementary DNA or cDNA (complimentary DNA), because you obtain DNA from RNA which works as a “mirror” or better like “a mold” from which you obtain the complementary shaped object. So before we can do the regular PCR process we must convert isolated and purified RNA into DNA.

Once you have the DNA, this is mixed with primers, which are sections of DNA designed to bind to characteristic parts of the virus DNA. Repeatedly heating then cooling DNA with these primers and a DNA building enzyme makes millions of copies of virus DNA. Fluorescent dye molecules bind to the virus DNA as it is copied. Binding makes them give off more light, which is used to confirm the presence of the virus in the sample. The fluorescence increases as more copies of the virus DNA are produced. If it crosses a certain threshold, the test is positive. If the virus isn't present, no DNA copies are made and the threshold isn't reached. In this case the test is negative.

The study made by Pieter Borger and the other 21 scientists that dismantle the Corman-Drosten is structured in 10 crucial flaws.

The first flaw: Drosten developed the diagnostic methodology without having the virus available.

Regarding the first point which is also the main one, Borger et al contest to Corman and Drosten of not having used the virus SARS-CoV-2 as primer for their test but to have used only fragments of it and that they eventually completed the sequence artificially or “in silico”. The labelling “In silico” means that the reproduction of the virus was not biological but they made it using a software hence it's a computer developed virus. Indeed it's called “In silico” because silicon is the matter which computers are made.

The justification brought by Corman and Drosten regarding the fact of not having the isolated virus available is that according to them the Sars-CoV-2 was very similar to the SARS-CoV of 2003 (which was discovered by Drosten himself on 2003)

In practice for the development of the Gold Standard (the referring virus to build the diagnostic test) Drosten thought he could ride on the coattails of another coronavirus which was also his own discovery and to complete the rest of the sequence with the computer:

the establishment and validation of a diagnostic workflow for 2019-nCoV screening and specific confirmation, designed in absence of available virus isolates or original patient specimens. Design and validation were enabled by the close genetic relatedness to the 2003 SARS-CoV, and aided by the use of synthetic nucleic acid technology”.

Victor Corman, co-author of the Corman-Drosten added: “We aimed to develop and deploy robust diagnostic methodology for use in public health laboratory settings without having virus material available.”

According to Dr. Pieter Borger, the promoter of the Corman-Drosten Review Report:

The focus here should be placed upon the two stated aims: a) development and b) deployment of a diagnostic test for use in public health laboratory settings. These aims are not achievable without having any actual virus material available (e.g. for determining the infectious viral load).

The objective of the Corman-Drosten study was to develop a diagnostic tool which was able to detect the presence of the SARS-CoV-2. Although, how can this objective be achievable if you don't have the Gold Standard which is the virus?

What is the Gold Standard?

In medicine and statistics, a gold standard test is usually the diagnostic test or benchmark that is the most accurate test available

The reliability of a diagnostic test is evaluated upon how accurately a test is able to identify if an individual is healthy or ill.

Indeed the Gold standard is nothing but the disease itself. In the case of Covid 19, the Gold Standard is the virus SARS-CoV-2.

Sometimes it can happen, like in the case of Corman-Drosten paper, that the Gold Standard, that is to say the disease, in this case the Covid 19 virus, is not available. That is why it is necessary to perform alternative methods to find it.

That's why the objection raised by Pieter Borger is more than understandable: Drosten wanted to create a test that was able to detect Covid-19 but how could Drosten make a reliable diagnostic Covid test without having the virus available but only its genomic sequence?

Consequently, according to Borger, without the real virus but only with its genomic sequence it wasn't possible for Drosten neither proceeding to the validation of the diagnostic test.

What is validation?

A diagnostic test is defined validated when you have evidence that the test provides a reliable result on the status of the examined specimen.

The validation of a diagnostic assay is that evaluation process necessary and indispensable to verify the validity of the test under the clinical point of view.

Usually the validation is being made on test animals and it's a process that is an integral part of the diagnostic methodoloy, because without the validation phase, the diagnostic methodology has no scientific value.

Obviously having not the virus available, Corman and Drosten couldn't perform the validation phase, hence the Corman Drosten diagnostic assay not only is incomplete but totally irrelevant under the scientific point of view, other than under the clinical one, because the methodology has not been integrated with the animal experimentation which is the condicio sine qua non in order for a diagnostic assay to be defined as such.

Flaw number 3: The amplification cycles

According to the retraction demand of the Corman-Drosten study, the fatal flaw number 3 is that the number of amplification cycles should be less than 35 (25-30)

What are the amplification cycles?

In the polymerase chain reaction, the Ct (Cycle Threshold) value is the number of amplification cycles that are necessary to detect the virus (and to state the subject as positive). In practice Ct is the threshold value of the cycles which are necessary to detect the virus.

The higher is the number of amplification cycles and more accurate is the diagnostic assay. This is one of the main flaws of the Corman-Drosten diagnostics: the fact of having established a too high number of cycles for the virus detection. What does it mean?

It means that if amplification cycles are too numerous they could even detect a flu that you had months ago and that's why the problem is no more that of false positive results but of the total unreliability of the diagnostics.

In case of virus detection, if the amplification cycles threshold is higher than 35, the detected signals are not associable to an infectious virus, like it has been established by the studies on the cell viral culture, first of all by the study known as Jafaar et al .

Correlation Between 3790 Quantitative Polymerase Chain Reaction–Positives Samples and Positive Cell Cultures, Including 1941 Severe Acute Respiratory Syndrome Coronavirus 2 Isolates.

According to Jafaar et al, if a subject is tested positive with the RT-PCR with a threshold of 35 cycles or higher, the chances that this subject is infected by the virus is less than 3% that's why the probability that this result is a false positive is of 97%.

Hence, the objections that dismantle the Corman-Drosten are not an exclusive prerogative of the ICSLS and of Pieter Borger. As a matter of fact the Borger initiative is just the lastest of a series of studies, mostly produced by the University of Oxford that had already completely dismantled the Corman-Drosten but without receiving any attention by the mainstream media.

We are talking here mainly of Jafaar et al which has demonstrated that the diagnostic methodology of the Corman-Drosten produces 97% of false positives. And the study Jafaar et al is not properly “new” as it was published on Clinical Infectious Disease on September 28 2020.

Although the statements by Boris Johnson and Dominic Raab were actually made before the publishing of Jafaar et al because the statement by Dominic Raab is of September 23 and that of Boris Johnson is of September 4.

If we read Jafaar et al indeed we find out that Jafaar cites a prior study always published by Clinical Infectious Disease, (a journal of pathogenesis published by Oxford University Press) the now legendary Bullard et al, whose title is: Predicting Infectious Severe Acute Respiratory Syndrome Coronavirus 2 From Diagnostic Samples published on May 22, 2020.

This is the paragraph in which Rita Jafaar cites Bullard et al

However, in an article published in Clinical Infectious Diseases, Bullard et al reported that patients could not be contagious with Ct >25 as the virus is not detected in culture above this value“

In practice Bullard et al proved that patients with a Cycle threshold superior to 25 are not contagious as the virus is not detected in culture above this value.

In addition Bullard et al says literally already in the Background section that the RT-PCR can only and esclusively detect RNA and not the infectious virus:

RT-PCR detects RNA, not infectious virus; thus, its ability to determine duration of infectivity of patients is limited. Infectivity is a critical determinant in informing public health guidelines/ interventions.

I repeat it once again, just in case: the RT-PCR diagnostics can only and exclusively detect the RNA and NOT the infectious virus. Consequently its ability to establish the duration of infectiousness of a patient is extremely limited.

Although the sentence that put the word end on the reliability of the RT-PCR is in the Results section of Bullard et al and it's the following:

There was no growth in samples with a Ct > 24 or STT > 8 days

There is no viral growth in samples with a Ct higher than 24 or when the time range between the symptoms onset and the test is greater than 8 days.

Probably the British Prime Minister had been informed of this discovery and that's the reason why on September 4 2020 he publicly stated that tests produced more than 90% of false positives.

Boris Johnson did not wake up the morning of September 4 and decided to dismantle the credibility of Covid-19 testing because he felt to do so. He was forced to do it because the fact of publicly stating it would legally exempt him from possible legal troubles in the moment in which it would have been discovered what thanks to Bullard et al and Borger et al we know today, that means that the Corman-Drosten is a diagnostic methodology which is clinically unreliable and that as we'll see now a total disaster.

As a matter of fact the fatal blow to the Corman-Drosten and more generally to the RT-PCR as virus detection diagnostic method was not provided neither by Bullard et al nor by Jafaar et al but by a third study, always published by the University of Oxford:  

Viral cultures for COVID-19 infectious potential assessment – a systematic review

This study, known as Jefferson et al was published first on August 4 2020 on the Nuffield Department of Primary Care website, then on September 29 on the open source medical journal medRxiv then on Clinical Infectious Disease on December 3 2020.

Despite the study is called Jefferson et al it is important to notice that one of the authors is Carl Heneghan, director of the Evidence-Based Medicine at the University of Oxford which just by chance on September 5 2020, the day after Boris Johnson released his statement on the false positives, was interviewed by Rachel Schraer, BBC Health correspondant.

On September 5 2020, BBC published this article titled: Tests could be picking up dead virus”.

In the mentioned article, Schraer invterviewed Carl Heneghan who had published his study more than a month before.

Why Henegan' study is so important?

Because it's not a simple study but it's a study that reviews the most relevant scientific studies regarding the culture of SARS-CoV-2 and it put them into relation with the RT-PCR test results and with other variables that could affect the interpretation of the test, like foreinstance the time range since the symptoms onset.

The main points of Jefferson et al that in practice have dismantled the Corman-Drosten well before Pieter Borger and the ICSLS are the following:

1) According to Jefferson et al, two studies reported the odds of live virus culture reduced by approximately 33% for every one unit increase in Ct.

2) Six of eight studies reported detectable RNA for longer than 14 days but infectious potential declined after day 8 even among cases with ongoing high viral loads.

According to Young et al (always cited in Jefferson et al) which is one of the most famous studies on SARS-CoV-2, the SARS-CoV-2 was detectable from nasopharyngeal swabs by PCR up to 48 days after symptom onset

3) Over 90% of the virus isolates were obtained from specimens with a Ct value below 23 (Jefferson et al page 5)

RT-PCR detects presence of viral genetic material in a sample but is not able to distinguish whether an infectious virus is present.

4) Presence of viral genome on its own is not sufficient proof of infectivity as you need proof that the isolate is capable of replicating.

The inability of PCR to distinguish between the shedding of live virus or of viral debris, means that it cannot measure a person’s viral load (or quantity of virus present in a person’s excreta) that means that the diagnostics is clinically unreliable.

This objection which is based upon Jefferson et al lab test results, it is also shared by England Public Health and it is published on the UK government guide for health workers Understanding cycle threshold (Ct) in SARS-CoV-2 RT-PCR A guide for health protection teams pag 6.

5) The RT-PCR by itself is not able to tell us if a specimen positive to the Covid-19 test is also able to transmit the infection and as confirmed by the other two main studies Bullard et al and Jafaar et al the specimens > 30 Ct have 0 probability of being infective. (The authors noted that a cut-off RT-PCR Ct > 30 was associated with non-infectious specimens).

6) Zhou and colleagues reported on samples taken from seven areas of a large London hospital (218 surface samples; 31 air samples) Despite apparent extensive air and surface contamination of the hospital environment, no infectious samples were grown.

7) In one study by Andersson et al, 20 RT-PCR positive serum specimens from 12 individual patients were selected at random from a Covid-19 specimen bank at 3 to 20 days following onset of symptoms. None of the 20 serum specimens produced a viral culture

8) The live viral culture time window was much shorter than for viral RNA identification, ranging from less than 8 days from symptom onset to test [w23] and Ct < 24 [w7]. Median duration of viral RNA identification in culture was 4 days (InterQuartile Range: 1 to 8) [w21].

What does this mean? It means that while the virus RNA can be detected in a specimen even after 40 days since the symptoms onset, the live viral culture can be detected in a specimen not beyond 8 days since the symptoms onset.

9) Jefferson et al concluded that the median duration of viral RNA identification in culture was 4 days.

10) Five studies reported no growth in specimens based on a Ct cut-off value ranging from CT > 24 to 35.The estimated probability of recovery of virus from specimens with Ct > 35 was 8.3%.

11) The last point of this list I would like to dedicate it to a less known study named Wolfel et al, Virological assessment of hospitalized patients with COVID-2019 which states as follows: “To understand infectivity, we attempted live virus isolation on multiple occasions from clinical samples (Fig. 1d). Whereas the virus was readily isolated during the first week of symptoms from a considerable fraction of samples (16.66% of swabs and 83.33% of sputum samples), no isolates were obtained from samples taken after day 8 in spite of ongoing high viral loads.

I have cited this study that doesn't stand out for peculiar virtues compared to the others but confirms those that preceded it (mainly Bullard et al) for a single reason: one of its authors is Victor Corman, the co-author of the Corman-Drosten. Indeed with this citation we reached the scientific paradox through which an author of a study that supports a diagnostic methodology affirms that a virus has a high infectious rate except claiming the contrary in another study.

We have however to notice that Wolfel et al was published on Nature on April 1st 2020 and we cannot exclude the fact that Victor Corman being one of the author is an April fool.

At the point number three of the retraction letter of the Corman Drosten it is affirmed as it follows:

"It should be noted that there is no mention anywhere in the Corman-Drosten paper of a test being positive or negative, or indeed what defines a positive or negative result. These types of virological diagnostic tests must be based on a SOP, including a validated and fixed number of PCR cycles (Ct value) after which a sample is deemed positive or negative. The maximum reasonably reliable Ct value is 30 cycles. Above a Ct of 35 cycles, rapidly increasing numbers of false positives must be expected .

According to Jaafar et al Above a Ct of 35 , it is not possible to obtain an isolate virus but only non-infective loads. We want to remind you here for the record that both the Corman-Drosten than the WHO recommend a cycle threshold of 45 cycles.

As a matter of fact the situation is even less dangerous than what Pieter Borger claims because the Bullard et al team had 90 specimen which resulted positive with the RT-PCR diagnostic and the viral culture tests on those specimens demonstrated that no growth happened with Ct>24 or with symptom onset >8 days.

The conclusion of Bullard et al is that the probability to obtain a positive viral culture reaches its peak on the third day since the symptoms onset, then decreases.

Bullard et al also showed that for every 1-unit increase in Ct, the odds of a positive culture decreased by 32%. Hence in practice passing from 25 to 26 Ct the probability to have a positive SARS-CoV-2 result decreases of 32%.

The Centre for Evidence-Based Medicine (CEBM) at Oxford University page dedicated to the monitoring of COVID 19 (Oxford COVID-19 Evidence Service) recommends as follows: PCR detection of viruses is helpful so long as its accuracy can be understood: it offers the capacity to detect RNA in minute quantities, but whether that RNA represents infectious virus may not be clear.

That means that the polimerasis testing can detect a fragment of the virus RNA and identify the specimen as positive but is this a live viral load? Is it infective? We have seen that the RT-PCR testing by itself cannot answer to this question but the protocols put in place by governments to limit our liberties are based exclusively on this blind system.

Dr. Kevin Corbett added: There are 10 fatal errors in the Drosten test paper. Public Health England is a co-author on it. All the public health authorities across the EU have co-authored this paper. But here is the bottom line: There was no viral isolate to validate what they were doing. The PCR products of the amplification didn’t correspond to any viral isolate at that time. I call it "donut ring science". There is nothing at the center of it. It’s all about code, genetics, nothing to do with reality, or the actual person, the patient.”

In practice this test with which they are determining who is positive and who's not and upon which the world governments have adopted restrictive measures of the freedom of millions of people is based upon nothing.

Celia Farber, journalist of Uncover DC replied to Dr. Corbett by reading him a few statements in which the covid virus has been isolated in a few labs around the world.

Yes, there have since been papers saying they’ve produced viral isolates. But there are no controls for them. The CDC produced a paper in July, I think it was, where they said: "Here’s the viral isolate". "Do you know what they did? They swabbed one person. One person, who’d been to China and had cold symptoms. One person. And they assumed he had it to begin with. So it’s all full of holes, the whole thing.”

What has been claimed by Dr. Corbett over the fact that Covid 19 virus still hadn't been isolated at the moment of the Corman-Drosten publication has been confirmed both by the CDC (Centers for Disease Control and Prevention) the US agency that monitors the Covid-19 and by the EDC (European Centre for Disease Prevention and Control) which is the european correspondant of the CDC.



In this document the EDC which is the european agency whose mission is to enforce the European defense against infectious diseases, the EDC states that at the date of april 16 2020 no virus isolate is available.



All this helps to understand the reason of the statements made by prime minister Boris Johnson and the foreign secretary Dominic Raab. In practice Johnson and Raab have felt the need to protect themselves under the legal point of view because with their statements they can claim to have informed the English audience regarding the unreliability of the Covid testing.

The EDC states Since no quantified virus isolate of the SARS-Cov2 is available…” and the date of the document is 16 April 2020

While the CDC states “Since no quantified virus isolates of the 2019-nCoV are currently available and the date of this document is 13 July 2020.

In practice from these two statements from the two main health institutions of the world which are committed to the study and the monitoring of Covid 19, for the US government and for the European Uunion we understand that nor in Europe nor in the US the Covid-19 virus has ever been isolated. “Isolated” means separated from the dead material contained in the examined specimen, like the patient's cells or possible bacterias. Although in both these statements the most important element is not the fact that the virus hasn't still been isolated but the following adjective: “quantified”. It is not necessary to have a degree in virology to understand that if a virus has not been quantified, it means that you don't even know the percentage that quantifies the virus respect to the leftover material . Nor if the european labs or the american ones are able to know in what percentage the virus is present in the examined specimens, which means that the CDC and the EDC staff members weren't able to distinguish the virus from the leftover material nor were they able to identify it.

The crucial element of these two documents is the confirmation of the fact that at the date of april 16 2020 the EDC had not isolated the virus of Covid 19 while Eurosurveillance had already approved the Corman-Drosten two months before and the WHO had already shipped the testing kits to the regions hit by the epidemic.

Dr. Corbett insists on the fact that Eurosurveillance approved the Corman-Drosten Study 24 hours after being submitted:

That never happens. It takes months to get a review done. They turned this around in 24 hours. It was waved through, it was not peer-reviewed. There’s no standard operational procedure for this test. There’s major and minor concerns about this paper and we go through it all here. it should be retracted. If they retract it, it means the whole thing falls to bits. The whole edifice collapses. It’s a house of cards built on sand and we’ve just moved the sand.”.

The retraction request of the Corman-Drosten is focusing on the fact that their methodology is too much based upon RT-PCR.

Clinicians need to recognize the enhanced accuracy and speed of the molecular diagnostic techniques for the diagnosis of infections, but also to understand their limitations. Laboratory results should always be interpreted in the context of the clinical presentation of the patient, and appropriate site, quality, and timing of specimen collection are required for reliable test results”. (Kurkela, Satu, and David WG Brown. Molecular-diagnostic techniques Medicine 38.10 (2009): 535-540.)

On July 1994 Newyorker journalist Celia Farber interviewed Kary Mullis for SPIN magazine (pag. 63) Kary Mullis was the inventor of the polimerasis chain reaction for which he received the Nobel prize for Chemistry.

Mullis repeated over and over that RT-PCR wasn't conceived for the virus diagnostic, so that in the interview with Celia Farber he stated:“PCR can detect HIV in people who tested negative to the antibody test"

The ECDC (European Centre for Disease Prevention and Control) makes two recomendations:

  1. That a hig Ct value (RNA amplification threshold) greater than 35 could be due to contamination by reagents and as a general recommendation at the point number 7

    the ECDC clearly states that specimens positive to the SARS Cov-2 must always carry a high viral load, which excludes all the so called “asymptomatic” from the category of individuals who can carry the infection.

  2. Despite the positive results can be indicative regarding the presence of Covid RNA in the patient a clinical correlation with the patient history and other diagnostic informations are crucial to determine the infective status of the subject.

  3. The fact that the Corman-Drosten is unreliable is clearly expressed in the UK government guide for health professionals: Understanding cycle threshold (Ct) in SARS-CoV-2 RT-PCR A guide for health protection teams which has been published on October 2020 which on page 6 says clearly: RT-PCR detects presence of viral genetic material in a sample but is not able to distinguish whether infectious virus is present. The quantity of intact virus in upper respiratory swabs will be affected by factors that are endogenous and exogenous to laboratory methods.

According to the ICSLS in the RT-PCR testing literature it is widely known that there are many risks like the functional false positives, that can lead to misinterpretation of test results. For this reason it is recommended for example by Kurkela et al that the RT-PCR is always used in tandem with a clinical diagnosis of the infection based upon symptoms. There are documented evidences of misinterpretation that created ghost pandemics like the 2004-2006 in which a respiratory disease was exchanged for an epidemic of pertussis thanks to the RT-PCR testing.

To summarise, the fatal flaws of the Corman-Drosten are the following:

  1. is non-specific, due to erroneous primer design

  2. is enormously variable

  3. The test cannot discriminate between the whole virus and viral fragments.

  4. has no positive or negative controls

  5. has no standard operating procedure

  6. It was not peer-reviewed

After the retraction letter sent by Pieter Borger and the other 21 scientists, Eurosurveillance published this statement:

We have recently received correspondence regarding a paper published this year, questioning both the content and the editorial procedures used to evaluate the article prior to publication. We can assure our readers and authors that we take comments relating to scientific content, the processing of articles and editorial transparency seriously. All articles published by the journal are peer-reviewed by at least two independent experts in the field (or at least one in the case of rapid communications). The article in question was also peer-reviewed by two experts on whose recommendation the decision to publish was made. Eurosurveillance is seeking further expert advice and discussing the current correspondence in detail. We will, according to our existing procedures, evaluate the claims and make a decision as soon as we have investigated in full. In the meantime, it would be unfair to all concerned to comment or discuss further until we have looked at all the issues.

According to Irish science writer Peter Andrews "All PCR testing based on the Corman-Drosten protocol should be stopped with immediate effect. All those who are so-called current ‘Covid cases’, diagnosed based on that protocol, should be told they no longer have to isolate. All present and previous Covid deaths, cases, and ‘infection rates’ should be subject to a massive retroactive inquiry. And lockdowns, shutdowns, and other restrictions should be urgently reviewed and relaxed”.

RNA Test devices not validated

There are 78 CE-marked RNA tests in the market. Nevertheless it is difficult to link scientific publications to specific CE-marked devices as said devices do not disclose the RNA sequences detected by the test. However what matters for us is that none of these tests has been controlled, inspected nor validated (the CE Mark label does not imply validation) and it's the European Commission that states this in the document: Current performance of COVID-19 test methods and devices and proposed performance criteria. As a matter of fact, validation is not legally obligatory for testing devices and this is the heart of this whole story. Since the European legislation doesn't require the testing devices to undergo validation in order to be CE marked, therefore it shouldn't surprise that the Corman Drosten has not been validated.

The Centre for Evidence-Based Medicine (CEBM) at the University of Oxford is a centre for the divulgation of scientific evidences whose director is Carl Henegan who is the co-author of Jefferson et al, one of the most relevant studies made until now on the Covid 19.

Since the Covid 19 emergency started, the Centre continuosly updates their website Covid 19 Evidence Service.

We have to acknowledge that CEBM has always been publishing updates that were excerpts from the studies we have been citing here: Jefferson et al, Bullard et al, Jafaar et al, Young et al etc. This means that the official British science always knew the real reach of this epidemic and always published the studies results and we have to acknowledge this merit to the University of Oxford without which today we would know nothing of this virus and we would be wandering among the darkness of ignorance and the panic created by our governments.

Unfortunately for our governors the University of Oxford does exist and works unspeakably well and very soon when such publications will enter the mainstream media our governments will have to take them into account.

The following notice on the status of COVID-19 is published on the UK government website


and it says literally: As of 19 March 2020, COVID-19 is no longer considered to be a high consequence infectious disease (HCID) in the UK.

The 4 nations public health HCID group made an interim recommendation in January 2020 to classify COVID-19 as an HCID. This was based on consideration of the UK HCID criteria about the virus and the disease with information available during the early stages of the outbreak. Now that more is known about COVID-19, the public health bodies in the UK have reviewed the most up to date information about COVID-19 against the UK HCID criteria. They have determined that several features have now changed; in particular, more information is available about mortality rates (low overall), and there is now greater clinical awareness and a specific and sensitive laboratory test, the availability of which continues to increase.

The Advisory Committee on Dangerous Pathogens (ACDP) is also of the opinion that COVID-19 should no longer be classified as an HCID.


The notice above is published on the UK government guidance on Covid 19 which you can find here but the page is not reachable through the www.uk.gov website. At least the undersigned wasn't able to find a direct link from the Covid 19 monitoring page. If the British government would like to explain us from what link on the website homepage is it possible to reach this page we would appreciate it very much. However the page does exist and this is the official statement of the British Government regarding Covid 19 and that IS NOT A HIGH CONSEQUENCES DISEASE.

As you can read yourselves, the labelling of Covid 19 not as a HCD from the British government, dates back to March 2020 and it is the stance recommended to the British government from the Advisory Committee on Dangerous Pathogens. Such position is officially documented by a letter sent from the president of the Advisory Committee Prof. Tom Evans to Public Health England on March 13 2020 when the Committee expressed itself unanimously.

The problem is that despite the recommendation of the Advisory Committee on Dangerous Pathogens which is a government outlet and despite the scientific papers published by the University of Oxford, the British government keep implementing restrictive measures which are in total contradiction to what is being affirmed by the major scientific institutions of the planet.

We have to acknowledge that even on the CDC website (the U.S. agency for the monitoring of diseases) both Bullard et al an Young et al are cited and in general it is acknowledged the non infectivity of Covid 19 after 10 days since the symptoms Onset but despite this the government institutions are implementing restrictive measures of our freedom of movement while forcing people wearing masks as if they are living into a parallel reality.

The question is: until when governments will ignore the medical scientific institutions?

Political consequences of the Borger et al initiative

At european level, the only administrative provision enacted until now that takes into account the above mentioned studies is a decision taken by the appeal court of Lisbon which ended a quarantine ordered by the local health department of the Azzorre islands to four german citizens.

According to the Court decision:“The PCR test is unable to determine, beyond reasonable doubt, that a positive result corresponds, in fact, to the infection of a person by the SARS-CoV-2 virus” The judges cited Jafaar et al and Surkova et al published on the Lancet: False-positive COVID-19 results: hidden problems and costs.

Following a notice published on December 14, the World Health Organization on January 13 published this notice whose recipients are the IVD users (In Vitro Diagnostic Users) who adopt the Corman-Drosten diagnostics. In the notice the WHO requests users to follow the instructions for use (IFU) when interpreting results for specimens tested using PCR methodology.

Users of RT-PCR reagents should read the IFU [Information for Use] carefully to determine if manual adjustment of the PCR positivity threshold is necessary to account for any background noise which may lead to a specimen with a high cycle threshold (Ct) value result being interpreted as a positive result.”

In practice the WHO in this paragraph states that adopting a high Ct (cycle treshold) can lead to false positive results.

In some cases, the IFU will state that the cut-off should be manually adjusted to ensure that specimens with high Ct values are not incorrectly assigned SARS-CoV-2 detected due to background noise.”

Performing the test with a high Cycle Treshold yields “background noise” that is false positive results. In practice the patient is told that he's positive while he's not.

The design principle of RT-PCR means that for patients with high levels of circulating virus (viral load), relatively few cycles will be needed to detect virus and so the Ct value will be low. Conversely, when specimens return a high Ct value, it means that many cycles were required to detect virus. In some circumstances, the distinction between background noise and actual presence of the target virus is difficult to ascertain.”

When the test is performed by adopting a high Cycle treshold is not possible to establish a difference between “irrelevant” and “meaningful”

As science never stops in the past few months scientific research went on and another study on Covid-19 was published on Nature: Van Kampen et al, whose title is Duration and key determinants of infectious virus shedding in hospitalized patients with coronavirus disease-2019 (COVID-19). The study not only confirms what Borger et al already found out regarding the false positive results produced by the RT-PCR but from the lab tests it seems the quantity of false positive goes well beyond 90% of results.

However the Corman-Drosten upon which the Covid diagnostic is based and all the data produced and divulgated by governments and media worldwide is practically crumbled on itself and in the scientific world it has now lost all its credibility.

Now the ball is in the hands of those who have to bring this information to the public, which means publishers and journalists.

The objective of this article was just to provide an overview and for what it was possible for a non-scientific piece the fallacy of the diagnostic methodology known as Corman-Drosten.

However it is not possible not to notice an abysmal discrepancy between scientific awareness regarding the scarce infectious potential of Covid 19 and the restrictive measures put in place by governments. We must conclude that the restrictive measures put in place to stop the spreading of Covid 19 have no scientific basis and they should cease immediately or the governments that implemented them they have the a duty to tell us why such measures have been put in place because covid 19 is not the real reason.



 
Gianluca D'Agostino worked for CNN in Washington DC and for Associated Press in Rome. D'Agostino has a Ph.D in Theory of Communication and Information at the University of Macerata. Former researcher at the Center for the study of the Novel at Stanford University, Visiting Scholar at the Film Studies Program at University of California Berkeley and Visiting Scholar at the Media and Communication Department of Fordham University NY.  

https://unimc.academia.edu/GianlucaDAgostino

https://www.oltre.tv/author/gianluca-d-agostino/