COVID-19 case counts are incorrect

It is spoken across our land in constant refrain, "We are just following the science." Unfortunately, there has been only selective reporting of the science related to COVID-19 that has led to unnecessary fear and hysteria.

Major media outlets seem to pick the science that supports a narrative and ignores completely other important scientific findings. Some government health authorities seem to pick the science that supports their policies for masks, lockdowns, treatments, and testing and ignore other science that would lead to less onerous and destructive policies restricting our personal freedoms. Having a rational discussion of ALL the science would lead to much less fear and more helpful policies aimed at balancing the need to protect the vulnerable and preserving our rights, freedoms, and means to make a living. This essay comments on COVID-19 case counts being artificially high due to errors in testing.

PCR testing that has been done for COVID-19 can be a faulty way, used by itself, to diagnose a case. PCR testing was mainly meant to be a research tool used to detect small amounts of a protein or chemical by amplifying the sample many times. PCR testing was not meant to be a stand alone test to define a case of COVID-19 infection. Doctors know the main diagnostic tool is to have a patient with typical symptoms and signs of the disease. Additional lab testing can confirm and support the diagnosis.

The answer to a PCR test is not yes or no -- the result can depend on how many amplification cycles are used. On any given set of samples, an amplification rate of 15(small) could be negative for all samples. If the amplification rate is 40 (high) then all the samples from the same set might be positive. For our COVID test in use, it is recommended that the cycle rate be set at less than 35 and closer to 25-30 is better.

The tests we are using are being run at cycle rates of 37-40. Some PCR tests using these high cycle rates are not picking up live virus, but only minute virus particles. This creates false positives and more "cases" that are not real cases. Dr. Fauci admitted this in an interview on "This Week in Virology" in July, stating that any test over cycle rate 35 is not finding live infectious virus, just virus particles. The New York Times reported in August that in their study of testing in Nevada, Massachusetts, and New York up to 90% of the tests may have been false positives detecting barely any virus.

The WHO put out a bulletin 3 weeks ago warning that the PCR test for COVID-19 should be run at the proper cycle rate to get a true positive. Why warn the world in January 2021 after almost a year of pandemic? In an independent review of European testing problems, it was stated by the scientists "If someone is tested by PCR as positive above 35 cycles(as is the case in most laboratories in Europe and the United States) the probability that said person is actually infected is less than 3%, the probability that said result is false positive is 97%".

Florida is the first state as of December 3, 2020 to mandate that the lab performing the PCR test report how many amplification cycles were used as a way curb false positives. Perhaps one reason Florida is now perceived to be doing well is because they are getting more accurate test results. Other RNA viruses(Mumps, Rabies, Hepatitis A) have both PCR testing and antibody/antigen testing available to confirm the clinical diagnosis. Antibody/antigen testing is in its infancy for COVID-19. New antibody tests for COVID-19 have come out recently that are more precise and can tell a patient not only if they have had the infection, but if the antibodies they are making protect them from disease.

Having a falsely high COVID-19 case count due to false positives can affect people’s perception of the dangers of infection and policy decisions. Politicians and bureaucrats are either ignorant of these nuances of testing or are intentionally trying to inflate the cases to support their policies.

It is very hard to tell how many tests so far have been false positives. I doubt it is the 90% that the New York Times found, but certainly not an insignificant number. In the New York Times article, the state lab of New York, the Wadsworth Center, analysed its COVID-19 testing. This found that of all people who tested positive at 40 amplification cycles, 45% would not test positive if the test was run at 35 cycles! A study in Clinical Infectious Diseases, found that virus could not be cultured in PCR cycles over 24. Many investigators believe the "second wave" that occurred in the fall around election time at a time of massive testing was due more to false positives than actual infectious cases.

Please be part of the solution to this problem. If you become ill and have the occasion to have a PCR test for COVID-19, ask your health care provider or the lab to report how many amplification cycles were used. If you are asymptomatic and get a positive test with a high amplification cycle, it is more likely to be a false positive than an asymptomatic infection. Better antibody/antigen tests will be available, so ask your health care provider if there is a better test to confirm a diagnosis. If you work in health care, lobby for accurate testing. In the political arena, ask our representatives to pass a law like Florida for more transparent and accurate testing.

If we continue to use the definition of a COVID-19 infection as a positive PCR test run at 37-40 cycles, we will continue down the wrong path. Apart from a rising COVID-19 case count adding to fear, anxiety, and media hysteria, persons with false positive tests do not need to quarantine, do not need contract tracing, and do not have to worry about being in the hospital. In my opinion, inaccurate testing has been one factor during the COVID-19 era that has led to more fear and anxiety for the public and over-reaction in our governmental response to this pandemic. Obtaining accurate testing and accurate reporting of true infectious cases would be a step toward being less afraid of the pandemic and less restrictive management that more accurately reflects the true risks of infection and preserves more of our freedoms.

Thomas T. Siler M.D. Disclaimer: I have no financial connection to the companies mentioned in the article.

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