Ontario has no protocols to ensure reliability of PCR tests

Hospitals and laboratories across the province are using astronomically high Ct levels for PCR tests, making the results less reliable
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Public Health Ontario (PHO) and Ontario Health — the two leading provincial government agencies that work with the Ministry of Ontario Health for the COVID-19 testing across the province — have no oversight or protocols on how the tests are administered.

INN24 reached out to the provincial health agencies regarding thier monitoring the Cycle Thresholds (Ct) levels used for different PCR tests for COVID-19 across the province. A Ct level represents the amount of amplification preformed during the testing procedure as it scans a sample for a specific protein linked to COVID-19.

INN24 has received emails confirming that Kingston Medical Science Center uses 40 to 45 Ct levels for COVID 19 tests. This is concerning since, accordign to the WHO, running PCR tests for more than 30 cycles will produce a high degree of false positives. It is important to note the tests are done on a logarithmic scale, so each cycle increases the amplification ten fold from the previous cycle.  

PHO, Ontario Health and the ministry, pointed to each other when INN24 asked who is responsible for oversight and why Kingston Medical Science Center has been using astronomically high Ct levels. What alarmed INN24 even more was the hospital’s statement that amplification “means little overall,” which, according to INN24’s research, is far from the truth. 

On December 7, 2020, the WHO made a public statement about the use of the RT-PCR “open systems” test and the amount of Ct used in diagnosing COVID 19. Responding to feedback on elevated risk for false SARS-CoV-2 results, WHO said: “Conversely, when specimens return a high Ct value, it means that many cycles were required to detect the virus. In some circumstances, the distinction between background noise and actual presence of the target virus is difficult to ascertain.” 

 

The WHO report goes on to further state: “The design principle of RT-PCR means that for patients with high levels of circulating virus (viral load), relatively few cycles will be needed to detect virus, and so the Ct value will be low.”

On January 20, the WHO released another statement regarding the PCR test and high Ct levels.

 

The PCR test creator, Kary Mullis, said in this video that “you can use the PCR test, and with enough amplifications, you can find almost anything.” 

A report published by Clinical Infectious Diseases on September 28, 2020, stated which Ct ranges are optimal for reliable RT-PCR test. “Several recent publications, based on more than 100 studies, have attempted to propose a cutoff Ct value and duration of eviction, with a consensus at approximately Ct >30 and at least ten days, respectively [2–5].” 

 

The report stated that above a certain Ct level the patient would not be contagious as the virus is not detectable in cultures.

Percentage of positive viral cultures of severe acute respiratory syndrome coronavirus 2 polymerase chain reaction–positive nasopharyngeal samples from coronavirus disease 2019 patients, according to Ct value (plain line). The dashed curve indicates the polynomial regression curve. Abbreviations: Ct, cycle threshold; Poly., polynomial. (Source).  

Dr Anthony Fauci, director of National Institute of Allergies and Infectious Diseases and chief medical advisor to the US president during the COVID outbreak, also emphasized keeping the Ct levels low. In this video he stated, “Anything over 35 Ct is “dead nuclei” and can’t even be cultured.”

Juliet Morrison, a virologist at the University of California, Riverside, explained in the New York Times: “Any test with a cycle threshold above 35 is too sensitive.  I’m shocked that people would think that 40 could represent a positive. A more reasonable cutoff would be 30 to 35.” According to the New York Times, up to 90% of positive tests at a Ct level of 40 would be negative at a CT level of 30.

In its COVID-19 report, PHO provides the number of COVID-19 positive cases, but it doesn’t offer any information about the amplification levels used to obtain the results. When INN24 asked PHO, Ontario Health, and the Ministry of Ontario Health about who oversees the agencies to ensure the integrity of these PCR tests, we did not get a reply.

This lack of oversight and transparency is exceptionally critical because after a 25 amplification level, a human body cannot transmit the virus and is not at risk. 

PHO did respond that the province licences all laboratories in Ontario. These laboratories are governed by the Laboratory and Specimen Collection Centre Licensing Act (LSCCLA). 

Moreover, PHO said that there are many different assays for the PCR tests, which makes for different Ct levels, and there’s no oversight to ensure the integrity of the positive results coming from Ontario labs.

When INN24 kept pushing for the information about the Ct levels used by Ontario hospitals, Prameet M. Sheth, the director of molecular microbiology at Kingston Health Science Center, said that “most PCR tests are in the range from 40 to 45,” and “total number of cycles … means little overall”, which directly contradicted several experts’ opinion.

 

When INN24 asked why the PCR tests were being conducted at such high amplification, Sheth failed to provide any insight. 

To conclude, there is no oversight of the protocols required to determine a positive COVID test.  Since overly amplified Ct levels are used for the test, it is difficult to acertain the quantity of false positives.  These highly dubious numbers are used to guide governing policies under the Emergency Act, affecting the lives of everyone in the province.

INN24 has requested the Ct level thresholds for all COVID-19 testing kits but have yet to recieve a response. Follow us for any future updates.

As INN24 holds transparancy as one of our core values, the entire email chain is provided below

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