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An investigation by Just the News revealed that health departments in several states do not track key data used to determine the infectiousness of people who test positive for COVID-19 with PCR tests. Current testing protocol may mean that “many of the ‘positive’ test results recorded throughout the country… denote nothing more than fragments of dead COVID virus,” Just the News reported.
PCR, or polymerase chain reaction, is one of the most common COVID-19 testing methods and has been called the “gold standard” by the government. Its reliability has come under fire repeatedly in recent weeks, including by the Centers for Disease Control (CDC).
The PCR approach amplifies viral genetic material in order to detect whether or not patient samples contain COVID-19. The number of amplifications that a PCR test must create before it identifies an infection is called “cycle threshold” or Ct.
“There is a correlation between the Ct value and the amount of viral genetic material that was present in the specimen,” the CDC says. A high-cycle threshold could indicate that positive test results may be derived from a non-infectious person who doesn’t need to isolate.
In an interview over the summer, Dr. Anthony Fauci, head of the National Institute for Allergy and Infectious Diseases, said, for a sample with “a cycle threshold of 35 or more,” “the chances of it being replication-confident are minuscule.” If the sample has more than a threshold of “37, 38, even 36,” “it’s just dead nucleotides, period,” he told listeners.
A report by the New York Times published in August noted that “[m]ost tests set the limit at 40, a few at 37. This means that you are positive for the coronavirus if the test process required up to 40 cycles, or 37, to detect the virus.” Researchers quoted in the article advised that “[a] more reasonable cutoff would be 30 to 35” “or even less,” the newspaper said.
“Those changes would mean the amount of genetic material in a patient’s sample would have to be 100-fold to 1,000-fold that of the current standard for the test to return a positive result… worth acting on,” they stated. Three sets of testing data processed by officials in New York, Massachusetts, and Nevada showed that “90 percent of people testing positive carried barely any virus,” according to the report.
Just the News contacted health departments in every state about cycle threshold data, finding that many simply don’t monitor it. “Overwhelmingly, health officials responded that they are more or less unaware of the cycle thresholds from the vast majority of tests occurring in their states,” Just the News reported.
An official from the Pennsylvania Department of Health told Just the News, “We do not get any cycle thresholds from any laboratories.” A representative of California’s health department similarly related, “The state does not maintain these values because it does not receive these from reporting labs.” The director of the Kentucky Cabinet for Health and Family Services admitted, “This information is not tracked by the Kentucky Department for Public Health.”
Officials from at least eight other states provided Just the News with statements denying that they keep track of the cycle threshold information from PCR tests.
“Many of the health officials qualified their responses with caveats about PCR tests and threshold data,” Just the News reported. For example, the administrator of Hawaii’s state laboratory said, “CT values depend on the chemistry used, the instrument used, and the nucleic acid extraction method used.”
He added, “there are many sources of variability.”
Nevertheless, medical experts besides Fauci have extolled the importance of cycle threshold data for months. Dr. Michael Mina, a Harvard epidemiologist, told the New York Times, “I would say that none” of people testing positive with low cycle thresholds “should be contact-traced, not one.” “It’s really irresponsible, I think, to forgo the recognition that this is a quantitative issue,” he said.
In a peer-reviewed study from May, Mina and another Harvard researcher argued, “particularly when testing in the absence of symptoms for COVID-19 … reporting the Ct value or range could help to better inform clinical decisions.”
A preprint article from the University of Oxford also states, “infectivity is related to the date of onset of symptoms and cycle threshold level.” Not validating “viral culture” of PCR samples “will result in false positives with possible segregation of large numbers of people who are no longer infectious,” the authors said. Former Pfizer Vice President Dr. Mike Yeadon recently condemned large-scale PCR testing, due to what he called “a severe risk of what we call a ‘PCR false positive pseudo-epidemic.’”
The validity of PCR tests has been contested for reasons other than Ct issues. An article in The BMJ has claimed that PCR nasal swabs have around 63 percent sensitivity. The researchers denied that there is any “gold standard” for COVID-19 tests.
In November, the CDC highlighted a study showing that screening for coronavirus with a single PCR test may only catch 53% of all positive cases. Last week, a group of scientists demanded the retraction of the original article describing the main PCR protocol used for COVID-19 testing, as a peer-review report for the article has failed to materialize.