Health News Digest

SARS-CoV-2 and COVID-19 testing

February 1, 2021

A Look At COVID-19 Testing

By Michael D. Shaw

The number of deaths attributed to COVID-19 is astonishing. To be sure, there is an ongoing controversy of how many of these deaths were due to (from) COVID-19 or reflect people who died, happening to also have a COVID-19 infection. An even more basic question is “How do we know when someone is infected with SARS-CoV-2?”

A good starting point to answering that question is the so-called Corman-Drosten paper, entitled “Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR.” The purpose of the paper was to “develop and deploy robust diagnostic methodology for use in public health laboratory settings without having virus material available.” This work has been used around the world by laboratories as a blueprint to design their own PCR tests and gain Emergency Use Authorization.

However, this paper, touted as “peer-reviewed,” was published less than 24 hours after it was submitted. In fact, a request letter to retract the paper was submitted on November 27, 2020—signed by 22 distinguished scientists. Moreover, an earlier request (October 26, 2020) to provide the peer review report of the Corman-Drosten paper was not answered. The signers of the letter now contend that no peer-review process was ever performed.

The signers also state that “Any molecular biologist familiar with RT-PCR (Reverse transcription polymerase chain reaction—the test being proffered) design would have easily observed the grave errors present in the Corman-Drosten paper before the actual review process.” More that that, two authors of the paper, Christian Drosten and Chantal Reusken, are also members of the editorial board of the publishing journal. Besides being a conflict of interest, the suspicion is created that rapid publication was possible simply because the authors were also part of the editorial board at Eurosurveillance.

The retraction request cites ten “major scientific flaws on the molecular and methodological level.” Quoting from the retraction request letter:

“The first and major issue is that the novel Coronavirus SARS-CoV-2 (in the publication named 2019-nCoV and in February 2020 named SARS-CoV-2 by an international consortium of virus experts) is based on in silico (theoretical) sequences, supplied by a laboratory in China, because at the time neither control material of infectious or inactivated SARS-CoV-2 nor isolated genomic RNA of the virus was available to the authors. To date no validation has been performed by the authorship based on isolated SARS-CoV-2 viruses or full length RNA thereof.”

As further explained here

The key to developing a successful PCR test is using a master copy of the genetic sequence that is pure and isolated. Any contamination of the master renders the test unreliable. The SARS-CoV-2 master copy, used for PCR testing, was derived from a synthetic RNA strand combined with viral fragments manufactured by Chinese scientists. In other words, scientists made an educated guess at the genetic sequence for SARS-CoV-2. At present, labs continue to use the synthetic virus even though a pure SARS-CoV-2 virus has been isolated.

The “educated guess” includes only two sections of viral RNA, and for this very reason is simply not able to accurately distinguish between SARS-CoV-2, and the many other coronaviruses.

While this article cannot do justice to all the scholarship represented in the retraction request letter, one more key point should be mentioned:

This 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.

According to the documentation for the TaqPath™ COVID-19 Combo Kit RT-PCR test (which utilizes the methodology described in the Corman-Drosten paper)…

1.     Positive results are indicative of the presence of SARS-CoV-2 RNA; 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.

2.     Negative results do not preclude infection with SARS-CoV-2 virus, and should not be the sole basis of a patient management decision.

3.     The assay is for in vitro diagnostic use under the FDA Emergency Use Authorization Only. This test has not been FDA cleared or approved.

All this should raise an alarm; only it probably won’t. I discovered quite long ago that science isn’t so much a search for truth, as it is a search for orthodoxy. After all, what are we now supposed to tell the millions of folks diagnosed using only the PCR test? As to the publishing journal, it is “[S]eeking further expert advice and discussing the current correspondence in detail.”

Funny. I thought that’s what an editorial board does.