Pennacchio: Basing Public Health Policy on One-Size-Fits-All PCR COVID Test May Be Wrong

Says Conflicting Data Could Be Unduly Influencing Public Health Policy

Concerned that aggressive testing for the COVID virus could be yielding ambiguous data, Senator Joe Pennacchio today called for the state to revise laboratory reporting on positive case numbers.

Pennacchio voiced his concerns in a letter to Health Commissioner Judith M. Persichilli requesting the Department of Health to require labs to disclose details about their methodology of testing.

The Senator’s letter referenced a story published in the New York Times under the headline, “Your Coronavirus Test Is Positive. Maye It Shouldn’t Be.” Citing leading public health experts, The Times reported, “The standard tests are diagnosing huge numbers of people who may be carrying relatively insignificant amounts of the virus.”

The commonly utilized PCR test, The Times article stated, “amplifies genetic matter from the virus in cycles; the fewer cycles required, the grater the amount of virus, or viral load, in the sample.”

Labs refer to the number of amplification cycles required to find the virus as the cycle threshold, and a higher threshold means a lower grade of infection. That is an important detail, and the information is not available to the public.

With each amplification cycle, viral traces in the sample are doubled. Most test facilities set a cycle limit from 37 to 40, but many experts claim a threshold above 35 is too sensitive and unnecessary, and positive readings would be inconsequential.

“Overly aggressive test protocols may lead to inflated positivity rates and contribute to public hysteria and panic,” said Pennacchio (R-26). “If they run excessive cycles, the test subject may have a minimal level of virus and is basically non-infected and non-contagious yet shows up as a positive COVID patient.”

The Florida Department of Health announced a new requirement that all labs involved in COVID testing must report the cycle threshold value of every test performed.

“There is no doubt New Jersey should be doing the same thing. It is vital so people can make informed judgements,” Pennacchio said. “Test results directly impact lives. A positive test, even for an asymptomatic patient, requires time away from work and a loss of income that families cannot afford.

“It is possible the state is basing public health policy on faulty data that seems to indicate COVID cases are exploding.”

The full text of the letter is below:

Dear Commissioner Persichilli,

With the reported increase of COVID positive cases and the exponential growth in testing, one wonders what if any New Jersey State standards have been applied to the PCR test.  The State of New Jersey has been guided by the results of these tests in formulating public policy.

I write to ask if the New Jersey Department of Health requires labs to disclose and keep records of the methodology of their testing.  Specifically, as you know, to increase the number of viral antigens to make them clinically recognizable, each sample is put through a number of “cycles,” in effect doubling the amount of COVID antigen materials with each cycle.

The question of course being asked by many is at what level of cycling can an actual COVID infection be determined?  This summer, New York Times estimated that up to 90% of COVID tests because of excess cycling may be false positive due to the repeated cycling of insignificant and or dead virus.  Determining the cycling level at which viruses can be cultured would be helpful in determining the potential for infections. Those levels have been reported to some varying degree. Even excess cycling may be useful in identifying and segregating our most susceptible population and beginning early treatment.

I am writing to ask you, if you have not already done so, to collate all testing results done in New Jersey and their respective cycling rates and to please share that information with our office.  Is it possible to determine if those rates correlate to an active infection, asymptomatic carrier or merely an exposure to a carrier?  I am also asking that the New Jersey Department of Health promulgate rules that would mandate each COVID PCR test identify and share with both the patient and New Jersey Department of Health, the number of cycles that was done for each individual PCR test.

Finally, working with the State’s epidemiologist, I would ask, if you have not already done so, to examine the amount of PCR test cycles and determine what if any correlation exists between those cycles and:

• actual COVID infections
• infected asymptomatic carriers
• non-infected carriers

Please share that information with my office.  I await your response.

Thank you in advance for your cooperation.

Sincerely yours,

Senator Joe Pennacchio
Senate Republican Whip