PCR Test for Coronavirus Questioned by Prominent Scientists

DEBATES ON COVID - VACCINES, 21 Dec 2020

Barbara Cáceres | National Vaccine Information Center - TRANSCEND Media Service

Scientist with gloved hand putting DNA sample into real-time PCR-cycler.

16 Dec 2020 – An International Consortium of Scientists in Life Sciences (ICSLS) have submitted a retraction request to the European public health journal Eurosurveillance of a well-cited article published in January 2020,^{1 2} which contained the first protocol for detecting the SARS-CoV-2 virus using a real-time polymerase chain reaction (PCR) test. The test has been used by the World Health Organization (WHO) as a guideline for other researchers.³

ICLS is requesting a formal retraction of the article.

The ICSLS retraction request, authored by 22 scientists with specialties in microbiology, virology, molecular genetics and molecular biology, immunology, pharmacology and other science fields, found “severe errors” in design and methodology of the RT-PCR which “render the SARS-CoV-2 PCR test useless.”⁴ The Eurosurveillance article has been cited over 800 times since publication.⁵

Quality of Peer Review Process Questioned

The paper, “Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR,” published by Victor Corman, lead researcher Christian Drosten and 22 other scientists, was received by Eurosurveillance on Jan. 21, 2020 and published online on January 23.

“Considering the severe errors in design and methodology of the RT-PCR test published by Eurosurveillance, this raises the concern whether the paper was subjected to peer-review at all,” write the authors of the retraction request.⁶ They further report that a request for the peer review report of the paper has not been provided on the grounds that “disclosure would undermine the purpose of scientific investigations.”⁷

Normally, the peer review process for publishing an article in a medical journal is a time-consuming process, since at least two experts from the field have to critically read and comment on the submitted paper.  The scientists allege that the 24-hour peer review process for the RT-PCR test article in question was far too short to analyze its accuracy. “In our opinion, this paper was not peer-reviewed,” the retraction request charges, adding:

Twenty-four hours are simply not enough to carry out a thorough peer review. Our conclusion is supported by the fact that a tremendous number of very serious design flaws were found by us, which make the PCR test completely unsuitable as a diagnostic tool to identify the SARS-CoV-2 virus. Any molecular biologist familiar with RT-PCR design would have easily observed the grave errors present in the Corman-Drosten paper before the actual review process.⁸

In a written response, Eurosurveillance responded:

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.⁹

Undisclosed Conflicts of Interest Revealed

Two authors of the Corman-Drosten paper, Christian Drosten and Chantal Reusken, are also members of the editorial board of Eurosurveillance. On July 29, 2020, two additional researcher’s conflicts of interest were added: Olfert Landt is CEO of TIB-Molbiol, and Marco Kaiser is senior researcher at GenExpress and serves as scientific advisor for TIB-Molbiol.

TIB-Molbiol was the first company to produce PCR kits based on the protocol published in the Corman-Drosten manuscript.  Further, Corman and Drosten failed to mention their affiliation with the commercial test laboratory Labor Berlin, where they were responsible for virus diagnostics using PCR testing.¹⁰

Design and Methodological Errors Make PCR Test for SARS-CoV-2 Diagnosis “Useless”

The scientists requesting retraction of the paper identified numerous methodological and design errors in the Corman-Drosten paper, including eight which the authors claim make the PCR test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus. Because the test cannot discriminate between the whole virus and viral fragments, they state that the test cannot make inferences about the presence of an infection.

The scientists making the retraction request note 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. The authors write:

These types of virological diagnostic tests must be based on a SOP [Standard Operational Protocol] including a validated and fixed number of PCR cycles (cycle threshold or 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.

“These PCR products have not been validated at molecular level”

Further, they state that only non-infectious (dead) viruses are detected with CT values of 35. “It is a significant mistake that the Corman-Drosten paper does not mention the maximum CT value at which a sample can be unambiguously considered as a positive or a negative test-result,” the authors write.¹¹

The authors add:

The fact that these PCR products have not been validated at molecular level is another striking error of the protocol, making any test based upon it useless as a specific diagnostic tool to identify the SARS-CoV-2 virus.

Cycle Threshold of PCR Tests Too High

These scientists are not the first to question the use of the PCR test to determine whether someone is infected with the SARS-CoV-2 virus, or to question the cycle threshold used to determine a positive test result. Many U.S. labs use 35-45 cycles while many European labs work with 30 to 40 cycles.¹²

Any test with a cycle threshold above 35 is too sensitive, says Juliet Morrison, PhD, a virologist at the University of California, Riverside. “I’m shocked that people would think that 40 [cycles] could represent a positive.” A more reasonable cutoff would be 30 to 35, she added. Michael Mina, MD, an epidemiologist at the Harvard T.H. Chan School of Public Health, said he would set the figure at 30, or even less.¹³

PCR Test Flaws Increase False Positive Results

According to The New York Times, up to 90 percent of positive tests at a cycle threshold of 40 would be negative at a cycle threshold of 30.¹⁴

Another researcher¹⁵ demonstrated that if a person gets a “positive” PCR test result at a cycle threshold of 35 or higher the chance that the person is infectious is less than three percent. The chance that the person received a “false positive” result above 35 cycles is 97 percent or higher.

Why do labs use such high CT values? From a public health or lab perspective, some think it is safer to accept a “false positive” result that puts a healthy, non-infectious person into quarantine, than to produce a “false negative” result and be responsible if someone infects a vulnerable person.¹⁶

Millions of False Positive Results

The Corman-Drosten paper reported a false positive rate of 1.2 percent in their laboratory. In the U.S., with 178.1 million tests performed through Nov. 21, 2020, the ICSLS scientists note that, “this equates to falsely labeling at least 2.3 million people as ‘infected with COVID-19’ with all the ensuing consequences.”¹⁷  They worry that the results of these PCR tests, including their false positive results, will be used by governments to justify policy decisions that will not be based on accurate cost-benefit analysis.

Consequences of False Positive COVID-19 Test Results

Until recently, false negative PCR test results for the SARS-CoV-2 virus have been given priority due to the consequences of undetected cases in health care and social care settings, and the transmission of infection, especially by asymptomatic or mildly symptomatic persons.

However, the consequences of a false-positive COVID-19 test result are not benign.¹⁸ A positive test taken for screening before elective procedures or surgeries may result in unnecessary and risky treatment cancellation or postponement of needed medical treatment.

Other individual costs of a false positive COVID-19 test can include income losses due to self-isolation or cancelled travel, and psychological damage due to fear, isolation or stigmatization, including increased rates of depression and suicide. Globally, financial costs include misspent funding and human resources for testing and tracing, unnecessary testing, funding replacements in the workplace, business losses, and loss of future opportunities for the youngest generations.¹⁹

The World Bank has stated that due to the pandemic measures, 88-115 million people will be forced into extreme poverty in 2020 with the total rising to 150 million by 2021.²⁰ Other societal costs include misdirection of policies regarding lockdowns and school closures and loss of autonomy and violation of human rights.

PCR Test Central to Pandemic Response

On Mar. 16, 2020, WHO Director General Tedros Adhanom Ghebreyesus told a news conference in Geneva, Switzerland, “We have a simple message to all countries—test, test, test.” Without testing, cases cannot be isolated and the chain of infection will not be broken, he said.²¹ As of Dec. 11, 2020 approximately 920 million SARS-CoV-2 tests have been performed worldwide.²² In the United States, the PCR test is used to screen people prior surgery or other health care procedures,²³ and a PCR test has become a prerequisite for students at universities, colleges, boarding schools, camps and sports programs, or to attend gatherings or meetings.

Scientific Integrity On the Line

The ICSLS scientists conclude:

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. How can the continuing use of the test protocol be justified after these findings? Furthermore, with knowledge of the misuse and misinterpretation of test results on a global arena, should we not be mindful of this test’s contribution to these terrifying consequences?

The decision as to which test protocols are published and made widely available now lies in the hands of the editors and publisher of Eurosurveillance. Retraction Watch, a blog that reports on retractions of scientific papers under the parent organization Center for Scientific Integrity, reports 39 scientific articles related to COVID-19 have been retracted in 2020.  Eurosurveillance is a non-profit journal published by the European Centre for Disease Prevention and Control.

The scientific community will be watching to see how the Eurosurveillance editorial board handles this retraction request of an article authored by two members of its own board.

References:

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