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Advanced Science Topics and Thought

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The intended use of the PCR test was, and still is, to apply it as a manufacturing technique, being able to replicate DNA sequences millions and billions of times, and not as a diagnostic tool to detect viruses. With PCR you are only looking at a small number of nucleotide – a tiny segment of gene, like a fingerprint. We should note that it is possible to have segments (parts) of materials in the test that have nothing to do with the corona virus that will still show up in PCR. This is because you can get down to the levels where its biologically irrelevant and then amplify it a trillion-fold.”. This is why orange juice spilled on the test will test COVID positive.

From what I read, as the virus has yet to be isolated and purified, they’re using the SARS test because they don’t really have one for the new virus. The PCR test is as close to a “Gold Standard” test for COVID as we currently have, but an actual tested, proven “Gold Standard” test has yet to be developed. As an example, for a pregnancy test the gold standard would be the pregnancy itself. But as Australian infectious diseases specialist Sanjaya Senanayake, for example, stated in an ABC TV interview in an answer to the question “How accurate is the [COVID-19] testing?”:

If we had a new test for picking up [the bacterium] golden staph in blood, we’ve already got blood cultures, that’s our gold standard we’ve been using for decades, and we could match this new test against that. But for COVID-19 we don’t have a gold standard test.”

Jessica C. Watson from Bristol University confirms this. In her paper “Interpreting a COVID-19 test result”, published recently in The British Medical Journal, she writes that there is a “lack of such a clear-cut ‘gold-standard’ for COVID-19 testing.”. But instead of classifying the tests as unsuitable for SARS-CoV-2 detection and COVID-19 diagnosis, or instead of pointing out that only a virus, proven through isolation and purification, can be a solid gold standard, Watson claims in all seriousness that, “pragmatically” COVID-19 diagnosis itself, remarkably including PCR testing itself, “may be the best available ‘gold standard’.”  But of course, it is downright absurd to take the PCR test itself as part of the gold standard to evaluate the PCR test! Plus, there are no distinctive specific symptoms for COVID-19, as even people such as Thomas Löscher, former head of the Department of Infection and Tropical Medicine at the University of Munich and member of the Federal Association of German Internists, advised (Article). And if there are no distinctive specific symptoms for COVID-19, then COVID-19 diagnosis cannot be suitable for serving as a valid gold standard.

There are some problems with the PCR Test, like that it is unable to derive whether the virus is active in the body. In fact, data from some US State Labs suggest up to 90% of people positively identified as having COVID-19 are no longer contagious and therefore do not need to isolate.

On Twitter, reporter Apoorva Mandavilli states, “It turns out that the PCR, that old reliable workhorse, is both too slow and too sensitive for what we need. And it all hinges on a metric called the ‘cycle threshold.,’”. Twitter post. What is a cycle threshold (Ct) value? It is the amount of amplification required for the material in test to cross the threshold to positive. The Ct value correlates with viral load – a lower Ct value indicates a higher viral load in the sample, and vice versa. Depending on the cycles as regulated by government agencies (per the situation), testers perform the PCR test using the specified cycle threashold. The higher the number of cycles, the greater the amplification, and the test might detect even small amounts of the virus that pose no risk of contagion. This is akin to finding a hair in a room long after a person has left. Lowering the cycle count reduces on the number of positives. I offer a supporting paper (that was withdrawn due to that it was a theoretical discussion which needs to be proven using real-world numbers) which advises that “nearly half or even more of the ‘asymptomatic infected individuals’ reported in the active nucleic acid test screening might be false positives”.

Recalling that above I mentioned ” Depending on the cycles as regulated by government agencies, testers perform the test using published Cycle Threasholds.” – it seems that the number of infections broadcast by the media were artificially inflated via the testing criteria established by the Government. WHY would this be done? Well, by cranking the sensitivity, the number of possible infections reported was as high as possible, exposing the ‘reach’ that the virus had in the community, but failing to be an advisory as to how many people were actually currently sick vs who had it prior or had some other ‘like’ detectable issue or failed tests. Plus, the virus may be significantly detectable in one region of the body, and extremely difficult to detect in the areas being tested by the PCR test, so they used sensitive testing. Even if the reported numbers (so long as they were unadjusted from those recorded and reported by the testing agencies) were majorally correct, they did not represent the number of ‘active’ cases nor their severity (the sensitivity was too high), nor if it really was COVID-19. After all, the specification sheets from manufacturers of RT-qPCR test kits for detecting SARS-CoV2 (in the specificity section) mention the lack of specificity by stating that other virus types can interfere with the detection of the SARS-CoV2 virus.

If the test is conducted at a 35 Ct threshold or above (which was recommended by the WHO), genetic segments of the SARS-CoV-2 virus cannot be detected, which means that ALL the so-called confirmed “positive cases” tabulated in the course of the last 18 months are invalid. According to Pieter Borger, Bobby Rajesh Malhotra, Michael Yeadon, et al, a cycle threashold of greater than 35 has been the norm “in most laboratories in Europe & the US”. As stated, this Ct is too high. Here is another document.

Supporting this further: an appeals court in Portugal has ruled that the PCR process is not a reliable test for Sars-Cov-2, and therefore any enforced quarantine based on those test results is unlawful. Further, the ruling suggested that any forced quarantine applied to healthy people could be a violation of their fundamental right to liberty. Most importantly, the judges ruled that a single positive PCR test cannot be used as an effective diagnosis of infection. Ruling here and translated here.

So it is interesting to note that the CDC is now recommending clinical laboratories and testing sites prior using the CDC 2019-nCoV RT-PCR test to choose and transition to another FDA-authorized COVID-19 test that can differentiate the difference between COVID-19 and influenza viruses.

“After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only.”, the CDC website states.

Are there other testing methods available?

Well, here is an interesting one that has been made available by the US Defense Advanced Research Projects Agency (Darpa). The television show, 60 Minutes, interviewed Dr. Matt Hepburn, an infectious disease physician and retired Army colonel, who revealed that the microsensor, which is not in widespread use outside the Defense Department, could help detect COVID-19 in an individual. Medical researchers at the Pentagon have created a microsensor implant that may eventually detect COVID-19 when inserted under the skin. Of course, it would be silly to believe that this technology would be provided to the general public – it would cost too much. (Article here)

Read the next section, “Risk / Reward Ratio“.