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U.S. CDC Admits COVID-19 Virus Has Not Been Isolated
The Short Story: PCR Test Results are Basically a Bunch of B-S
By: David Deschesne
October 21, 2020
Distrust among the public in the now infamous COVID-19 PCR testing process has now gotten even worse as the US CDC admits the PCR tests being used are not based on samples of actual, isolated COVID-19 viral particles.
An instruction manual for the RT-PCR process for detecting SARS CoV-2, entitled, “CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel”1 published on July 13, 2020 admits the COVID-19 coronavirus has not been isolated by stating, “Since no quantified virus isolates of the 2019-nCoV are currently available, assays designed for detection of the 2019-nCoV RNA were tested with characterized stocks of in vitro transcribed full length RNA of known titer spiked into a diluent consisting of a suspension of human A549 cells and viral transport medium to mimic clinical specimen.” (page 39)
The above admission seems to indicate that the CDC is using a best guess substitute designed to “mimic” COVID-19 rather than the actual virus itself in designing the PCR tests that are supposed to identify it.
In the panel, the CDC also suggests not to put too much faith in PCR “positive” results by admitting, “Positive results are indicative of active infection with 2019-nCoV but do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of the disease.” (page 2)
Normally, if a lab modifies a test with unauthorized components, the test results would be unacceptable. However, the CDC panel says, “If a laboratory modifies this test by using unauthorized, alternative components, the modified test is not authorized under this [Emergency Use Authorization]. As part of this policy, FDA does not intend to object when a laboratory modifies an EUA-authorized test, which could include using unauthorized components, without obtaining an EUA or EUA amendment…”
It further states the COVID-19 PCR test “has not been FDA cleared or approved” and that it “has been authorized by FDA under an EUA for use by laboratories certified under CLIA to perform high complexity tests.” (pages 9-10)
Intriguingly, the CDC also admits, “positive and negative predictive values are highly dependent on prevalence. False-negative test results are more likely when prevalence of disease is high. False-positive test results are more likely when prevalence is moderate to low.” (page 37)
This attribute of the PCR test for COVID-19 makes the entire results incessantly reported by the corporate media completely irrelevant. Furthermore, the CDC admits the test is authorized out to “40 cycles” which, according to a New York Times article, is too sensitive and creates too many positives in cases where the person may have had a past infection with stray, broken viral particles still lingering, but is no longer sick or infectious.
The CDC concludes, “Detection of viral RNA may not indicate the presence of infectious virus or that 2019-nCoV is the causative agent for clinical symptoms. The performance of this test has not been established for monitoring treatment of 2019-nCoV infection.” (page 38)
1. Ref: https://www.fda.gov/media/134922/download