External peer review of the RT-PCR test to detect SARS-CoV-2 reveals 10 major scientific flaws

UPDATE since first posting: The World Health Organization (WHO) has acknowledged the many complaints and letters sent to them regarding PCR tests and has issued a warning about false results. Their warning does not acknowledge all the major flaws as outlined below, but it is a beginning toward addressing the “casedemic” that is driving destructive, restrictive policies around the world.

An international consortium of life-science scientists performed an extensive review of the pivotal study, referred to as the Corman-Drosten paper, that led to the global use of the RT-PCR tests to detect SARS-CoV-2 and diagnose “cases.” They found 10 major scientific flaws at the molecular and methodological levels.

These flaws are leading to false positives, which in turn are driving harmful restrictive policies around the world that are leading to bankruptcies, economic collapse, starvation in poor communities and nations, and much more. No aspect of human life has been untouched by the restrictive responses. Public health agencies are calling all “positive” PCR test results “cases” and saying that because of the rise in “cases”, even with the coming liability-free experimental vaccines, many restrictions will continue.

Their final conclusion?

“In light of our re-examination of the test protocol to identify SARS-CoV-2 described in the Corman-Drosten paper we have identified concerning errors and inherent fallacies which render the SARS-CoV-2 PCR test useless.”

https://cormandrostenreview.com/report/

 

While the Corman-Drosten paper was about the German RT-PCR test, their findings are relevant to all RT-PCR tests currently being used in the United States and around the world.

“This report has relevance far beyond the German test, indeed it is a blueprint for understanding point by point whether any of the qRT-PCR tests in US and around the world have followed best practices for the development of nucleotide-based molecular assays: each individual test should use positive and negative controls, and all should follow empirically standard operating procedures (SOPs) optimized considering for the prevalence of SARS-CoV-2.  The primers pairs should number at least three per test, and each kit should have been demonstrated to have low empirical false positive rates in thousands of human samples without SARS-CoV-2 infection.  While the Cormon-Dorsten test was demonstrated to have no false positives with mucous samples from 100 patients with respiratory illness that could not be attributed to SARS-CoV-2, none of the tests awarded EUAs by FDA had been tested for false positives in people without any respiratory viral infection.  Likewise, none had been tested for pathogen specificity.  Instead, computational assessment of the match of primers to the human genome was used to predict low specificity.  Now we have empirical evidence of unacceptably high field false positive rates from Basile et al. (2020) (11%) Lee (2020)  (30%) and the marine recruit study – although the authors of that study failed to recognize their own false positive rate of 40%.”

James Lyons-Weiler, PhD and editor of Science, Public Health Policy, and The Law

The authors that reviewed the Corman-Drosten study provide this summary of the errors they found (see the full paper for detailed explanations).

1. There exists no specified reason to use these extremely high concentrations of primers in this protocol. The described concentrations lead to increased nonspecific bindings and PCR product amplifications, making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.

2. Six unspecified wobbly positions will introduce an enormous variability in the real world laboratory implementations of this test; the confusing nonspecific description in the Corman-Drosten paper is not suitable as a Standard Operational Protocol making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.

3. The test cannot discriminate between the whole virus and viral fragments. Therefore, the test cannot be used as a diagnostic for intact (infectious) viruses, making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus and make inferences about the presence of an infection.

4. A difference of 10° C with respect to the annealing temperature Tm for primer pair1 (RdRp_SARSr_F and RdRp_SARSr_R) also makes the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.

5. A severe error is the omission of a Ct value at which a sample is considered positive and negative. This Ct value is also not found in follow-up submissions making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.

6. The PCR products have not been validated at the molecular level. This fact makes the protocol useless as a specific diagnostic tool to identify the SARS-CoV-2 virus.

7. The PCR test contains neither a unique positive control to evaluate its specificity for SARS-CoV-2 nor a negative control to exclude the presence of other coronaviruses, making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.

8. The test design in the Corman-Drosten paper is so vague and flawed that one can go in dozens of different directions; nothing is standardized and there is no SOP. This highly questions the scientific validity of the test and makes it unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.

9. Most likely, the Corman-Drosten paper was not peer-reviewed making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.

10. We find severe conflicts of interest for at least four authors, in addition to the fact that two of the authors of the Corman-Drosten paper (Christian Drosten and Chantal Reusken) are members of the editorial board of Eurosurveillance. A conflict of interest was added on July 29 2020 (Olfert Landt is CEO of TIB-Molbiol; Marco Kaiser is senior researcher at GenExpress and serves as scientific advisor for TIB-Molbiol), that was not declared in the original version (and still is missing in the PubMed version); TIB-Molbiol is the company which was “the first” to produce PCR kits (Light Mix) based on the protocol published in the Corman-Drosten manuscript, and according to their own words, they distributed these PCR-test kits before the publication was even submitted [20]; further, Victor Corman & Christian Drosten failed to mention their second affiliation: the commercial test laboratory “Labor Berlin”. Both are responsible for the virus diagnostics there [21] and the company operates in the realm of real time PCR-testing.

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