Kari Mullis Explains PCR Testing

PCR Test Inventor Kary Mullis (1944-2019)

We are very appreciative of Scott and Rock Island Counties' Health Departments' participation. I disagree with Dr. Katz referring to our questions concerning cycle thresholds in PCR testing as “trivial.”

This precise controversy is quickly gaining in prominence and urgency.  (For responses to all eleven questions we posed, see "Dr. Katz Answers 11 COVID-19 Questions.")

PCR (Polymerase Chain Reaction) tests are remarkable things. Inventor Kary Mullis (1944-2019) won a Nobel Peace Prize in 1993 for its far-reaching impact on the world of virology, microbiology, and so much more. The PCR test can detect almost anything microbial, no matter how tiny, but it cannot determine how much of the microbe is there. Therein lies the crux of the controversy inherent in diagnosing COVID-19 cases using PCR testing.

PCR tests detect viral fragments from nasal or throat samples using cycle thresholds (amplification). If viral fragments are found at lower thresholds (1-30), that indicates a lot of the virus is likely present because it was found quickly. But if cycle thresholds cycle beyond 30 times, it means the viral fragments are so few that they are impossible to detect. Instead, a microbial piece of dead virus or nucleotide is detected and easily mistaken for the virus fragment, as explained by Dr Fauci during an interview with This Week In Virology, July 2020. (See Fauci's observations in Question #1 of "Dr. Katz Answers 11 COVID-19 Questions.")

Precisely because PCR tests are purely qualitative (and not quantitative), this molecular testing technology heretofore has been universally rejected as preliminary diagnostic tools for infection and disease. Predictably, as a result of PCR's predominate use in diagnosing COVID-19, increasing numbers of medical and science professionals are uneasy because 70-90 percent of positive PCR test results, generated using 35 or higher cycle thresholds, are “false positives,” requiring additional testing for definitive case confirmations.

False-positive results are common with PCR testing, and occur with more frequency as cycle thresholds increase. Since so few cultures are being done, using the same virus fragments from the samples that tested positive, to verify active SARS-CoV-2, let alone verify enough to cause COVID-19 disease, PCR testing for diagnosis is largely inconclusive, therefore hardly trivial. The New York Times underscored PCR's limitations to effectively assess widespread risk relative to infection and/or disease during outbreaks, epidemics, or pandemic-level events back in August 2020. [RCReader.com/y/pcr1]

At a minimum, in the spirit of precision, positive tests at high-cycle thresholds should be considered negative unless some other contravening evidence is present, such as symptoms. This is especially true for SARS-CoV-2 because the vast majority of people, who test positive for a potential fragment of SARS2 virus, are asymptomatic. Yet all positives test results are automatically diagnosed as a confirmed case of COVID-19.

CDC's Case Definition Does Not Cite the Causul Virus

CDC's definition of a COVID-19 case is overly broad: “In the United States, a confirmed case of COVID-19 is defined as a person who tests positive for the virus that causes COVID-19.” This COVID definition does not identify SARS-CoV-2 as the causal virus, and is an unusual departure from CDC's other viral case definitions requiring additional definitive steps, such as antigen/antibody tests and/or clinical observation of symptoms, before confirming an active case. [RCReader.com/y/pcr2]

This is true for HIV, Hepatitis C & B viruses, all three of which use specifically tailored antigen and antibody blood tests that definitively diagnose active or past infection, and associated diseases of AIDS, cirrhosis, and liver failure, respectively. [RCReader.com/y/pcr3]

So riddle me this: if PCR testing consistently results in significantly large numbers of false-positives for asymptomatic people and frequently misdiagnoses COVID cases, why is the PCR test still being used as the predominate diagnostic tool?  Again, in the spirit of precision, why not lower the cycle threshold range and standardize it to reduce false-positives for more accurate, responsible diagnosing? [RCReader.com/y/pcr4]

It becomes critical to eliminate false positives as people are not transmitting infection that they do not have. No biotechnology to date can definitely prove the amount of active virus present or its meaningful correlation to transmissibility. Presuming infection and transmissibility in asymptomatic people based on inconclusive testing triggered by a contact case, is both scientifically and medically unreasonable, notwithstanding Dr. Katz's accommodating predictive modeling.

Locking down entire populations based on fear of transmitting a non-lethal virus that 99 percent of the population survives, including 94 percent of our elderly without serious comorbidities, is medically irrational on its face. It should be noted that comorbidities are documented on death certificates in both Rock Island and Scott County. The Reader published the comorbidities cited on death certificates for those recorded as dying from COVID-19 to date in Scott County, back in September [RCReader.com/y/rcr977]. Illinois state law currently disallows the public access to death certificates unless they are a party to the deceased or need it for medical research.

Katz Understanably Dismisses Differences Between Infections and Cases as Semantics

Let's recap: Asymptomatic people with positive test results account for the large majority of cases, thanks to the FDA approving the use of PCR tests with unusually high cycle thresholds in order to detect even the smallest fraction of a fragment. Credit can also be given to the CDC for conveniently sanctioning any fragment detection as a confirmed case of COVID-19. In this way, Dr. Katz understandably dismisses infections of SARS2 virus and cases of COVID disease as semantics because the health authorities curiously treat them as one-in-the-same. Even if they are not.

Considering this subjective surveillance of COVID, why should the world trust that continued extensions of unwarranted mitigations won't be prolonged indefinitely when global testing, by design, will continue to unreliably produce more cases, thereby amplifying the positivity rate that perpetuates the extensions?

Higher cycle thresholds for individual patients goes to the heart of the skepticism that underpins growing discomfort regarding PCR's testing reliability in confirming active SARS-CoV-2 infections and cases of COVID-19 disease.

Referring to the “huge bulk of contact cases from symptomatic cases,” Dr Katz appears to be focused on transmissibility and spread. Because no process to date can tell us how much viral load is needed to be contagious, nor the amount needed to develop illness, indifference to the large number of asymptomatic cases that are false positives is counterproductive.

Concentrating on the huge bulk of contact cases using a Bayesian model that predicts transmission and probability of new cases, all relying on PCR testing that generates inconclusive results if the cycle thresholds are too high, would necessarily require additional verification by other means for the models to accurately predict the true rate of transmission (spread of infection) and subsequent live cases. How is that verification accomplished? And if it is not happening for a statistically significant portion of the asymptomatic people who tested positive, how can the model credibly predict the spread of COVID?

The looming controversy surrounding PCR testing boils down to its systemic diagnostic limitations, and overcoming the high percentage of false positives that undermine the actual rate of infection and disease.

PCR Cycle Thresholds Beyond 35 Meaningless

The established rule of thumb is cycle thresholds greater than 30 are unreliable and require culturing and clinical observation to confirm live/active infection and/or illness/disease. Culture thresholds greater than 35 are meaningless and likely detecting remnant viral fragments, resulting in mostly false positives. Finally all cycle thresholds 40 and above are junk and should automatically be considered negative. Better yet, prohibit testing cycle thresholds greater than 35 and exponentially reduce false positives and uncertainty.

The unreliability of PCR testing as a diagnostic tool is so well-documented throughout the infectious-disease research community that it is bewildering as to why Emergency Use Authorization (EUA) for PCR Tests, using problematic higher cycle threshold ranges of 35-45, was approved by the FDA, then adopted by the CDC as the only requisite for a positive confirmation of SARS-CoV-2 infection and automatic confirmed case of COVID-19 disease. In The Lancet's article “Understanding COVID-19: What does viral RNA load really mean?”, the authors write, “The inability to differentiate between infective and non-infective (dead or antibody-neutralized) viruses remains a major limitation of nucleic acid detection.” [RCReader.com/y/pcr5]

According to the peer-reviewed study published in Oxford Academic Clinical Infectious Diseases – Correlation Between 3790 Quantitative Polymerase Chain Reaction-Positives Samples and Positive Cell Cultures, Including 1941 Severe Acute Respiratory Syndrome Coronavirus 2 Isolates,”It can be observed that at Ct = 25, up to 70% of patients remain positive in culture and that at Ct = 30 this value drops to 20%. At Ct = 35, the value we used to report a positive result for PCR, <3% of cultures are positive.” [RCReader.com/y/pcr6]

Cycle threshold ranges vary per testing laboratory, and each range can be found at the FDA. [RCReader.com/y/katz1]. 
Every individual tested is entitled to all his/her testing data, including the specific cycle threshold used. Therefore everyone should request their cycle thresholds be included with their results. Florida's State Health Department recently mandated that test providers include cycle thresholds in reporting all test results to the state. [RCReader.com/y/pcr8]

Medical doctors, scientists, researchers, and frontline healthcare providers are now standing resolutely in opposition to the inexplicably exaggerated narrative, championed by mainstream media and social engineers, that COVID-19 is a lethal pathogen threatening humankind.

Various organized efforts worldwide, including the Great Barrington Declaration, GBDeclaration,org, and the recent Review report Corman-Drosten et al. Eurosurveillance 2020, Nov27, 2020 submitted by the international Consortium of Scientists in Life Sciences (ICSLS), External peer review of the RTPCR test to detect SARS-CoV-2 reveals 10 major scientific flaws at the molecular and methodological level: consequences for false positive results. [RCReader.com/y/pcr9] This report is a condemnation and formal request for retraction of the controversial Corman-Drosten report Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR, submitted and published in Eurosurveillance on January 23, 2020. [RCReader.com/y/pcr10]

The ICSLS contend, “After careful consideration, our international consortium of Life Science scientists found the Corman-Drosten paper is severely flawed with respect to its bio-molecular and methodological design." 

It was the January 2020 Cormen-Drosten report that propelled PCR testing for COVID diagnoses to the forefront after endorsement by the World Health Organization.

Today, hundreds of thousands of medical, academic, and scientific personnel are aligning to oppose the irresponsible use of PCR tests that are falsely diagnosing millions of people with active cases of COVID-19 disease and sowing widespread societal fear that continues to interfere with people's ability to rationally navigate all the indicators, credentialed research, and evidence-based-medicine (EBM) now available that COVID-19 is not a lethal pathogen as first feared, nor worthy of continued pandemic status. [RCReader.com/y/pcr11 and RCReader.com/y/pcr12]

Health Authorities Can No Longer Deny COVID-19 is Not the Lethal Threat Originally Feared

Now comes a greater burden on health authorities to reassure the public by proving COVID-19 is still an authentic pandemic-level lethal threat to humans beyond the inflated positivity rate that appears to be driving the bus relative to policies and mitigations. Again, modeling that predicts transmissions, pre-symptoms, hospitalizations, excessive burden on services, are calculated using the number of rising cases (positivity rate) that come almost entirely from inconclusive PCR testing.

Health authorities can no longer ignore or dismiss rational arguments that COVID-19 is not the lethal threat it was originally feared to be. A revised risk assessment must occur to correct for false positives so we can dial back excessive, severely destructive mitigation policies that are killing far more people than COVID ever will. A compelling analysis of lost life years due to prolonged extreme mitigations should be required reading to provide perspective for those virtue signaling around COVID-19 mask-wearing, social distancing, isolating, inequitable shuttering of businesses and schools. [RCReader.com/y/pcr13]

Now to the gigantic pink elephant missing in the COVID narrative – no corresponding deaths, not even close. This is true worldwide. There are so few deaths from COVID-19 relative to the astronomically high number of cases. Nor are excess deaths worldwide excessive compared to earlier years, and/or compared to deaths from past influenza, pneumonia, respiratory disease, heart disease, cancer, obesity and a plethora of other illnesses that comprise all-cause deaths. [RCReader.com/y/pcr14]

False-positives go a long way in explaining why the mortality rate of COVID-19 is infinitesimal when compared to the astronomical rise in cases. If far less people are actually infected, not sick with disease, nor contagious, a lower death rate would reflect this reality. And so it does. [RCReader.com/y/pcr15]

Ninety-nine percent of humans survive COVID-19, 80 percent are presumably asymptomatic and unaware they have it, while only 10 percent feel mild symptoms. Of the remaining 10 percent who experience more severe symptoms, most fully recover with only one percent succumbing, largely with underlying conditions that were already life threatening.

Supporters for excessive mitigations to prevent the spread of COVID-19 claim COVID compromises patients by exacerbating their illnesses and causing premature deaths. Therefore COVID-19 is appropriately declared and recorded as the cause of death. Unfortunately such declarations are speculative and unverifiable without additional clinical/epidemiological review, further affirmative testing, and/or autopsies confirming that COVID-19 was the primary cause of death.

How Many Premature Deaths Due to Excessive Response is Acceptable?

Dr Katz poses the question, “If our response to the pandemic is inappropriately excessive, I would ask how many premature deaths are we willing to accept?” My counter question is how many premature deaths are we willing to accept due to our inappropriate excessive response to the pandemic?

The widespread suffering due to inequitable mitigation directives and enforcement is becoming increasingly intolerable. Leaders cannot cherry-pick victims in a vacuum. Eventually unfair authoritarian abuse reveals itself, regardless how immobilized a population is from a relentless barrage of fear-mongering unleashed upon them by corporate broadcast, cable, social, and print media.

Merely attesting that PCR tests are reliable in diagnosing live cases of COVID-19 no longer suffices in dispelling legitimate controversies and deepening concerns amid a toxic environment of censorship, social engineering, animus towards and marginalization of highly credentialed skeptics from myriad fields of expertise.

The productive course for health authorities now, if they are to preserve trust and credibility going forward, is to acknowledge COVID controversies and concerns by confronting them head-on with full transparency, including a sincere and robust effort to engage skeptics in open, inclusive debate to persuade or dissuade, and by providing unfiltered access and sharing of relevant data.

The growing disconnect among health authorities and average Americans, including many of our beloved providers and healthcare workers, will come into sharp relief when COVID-19 vaccines arrive for deployment and there are unsatisfactory numbers of takers.

Health authorities and leaders, who have an expectation of herd compliance with no resistance to injecting highly controversial vaccines using brand new technology, indicates a peculiar detachment and lack of compassion for genuine deeply-felt fears over such programs among the populace they are tasked to serve and care for. Persisting in policies that knowingly do harm crosses a line that no emergency management authority or legislative immunity can overcome.

People are infinitely more level-headed and able to cope calmly if they have reliable, trustworthy facts to inform them. An informed community is an invaluable asset for cooperation and problem solving, not a liability to be manipulated and managed. Unwisely, the messaging to date worldwide has fostered the polar opposite environment and it is unsustainable. “We are in this together” are empty words without full transparency from trusted voices on all things COVID.

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