The Emperor's New Clothes - part 11
The PCR test - How to rig the test for the will of industry - a guide.
When I started my research on the PCR tests - somewhere during the year 2020, I found a lot of scientific criticism about the validity of the PCR tests as a method of diagnosing diseases. I will elaborate later on some of these problems. At that time (2020) I did not had, specific information about which test kits are being used in Israel. It is important to note that there are many dozens of test kits produced by many manufacturers in the world and for each such test a thorough understanding of the test protocol and its biological characteristics is necessary. Therefore, one of the first steps was to receive from the Ministry of Health the details of all the test kits that are in use in Israel. The MoH did supply a list of all the test kits used in Israel. You can find the list in this link.
I also asked the MoH for a protocol for each kit, but it seems that the Ministry of Health chose to make it difficult for me and they simply replied that the protocol for the test could be retrieved from the test manufacturer.
Since no protocol information was provided by the MoH, I had to search for the relevant protocols myself. I took the following protocols that will be presented (2 examples from the long list) from the FDA website in a document submitted to receive an EUA on behalf of the manufacturing company. By the way - it should be noted that similar to the injections (the "vaccination"), the covid tests were also approved for use on the basis of an EUA and never went through an orderly and thorough approval process.
We will examine the protocol of the following kit: Seegene Inc – Allplex 2019n-CoV Assay
Let's explain briefly the principle behind the PCR test is and what the number of amplification cycles means.
The PCR test is based on the amplification of a small segment of genetic material so that at the end of the process from a tiny (indistinguishable) amount of the same genetic material - we will get a large enough amount that can be detected by a sensor. The principle of operation in PCR is to take a known section of genetic material that corresponds to a specific gene that you are looking for and by an enzymatic process - multiply it again and again until you get a large amount of it. This is the amplification process. In each cycle we get a double amount of material compared to the previous cycle. That is, it is an exponential amplification process. The principle of amplification/multiplication can be seen in the diagram below. Note that after 35 cycles we have 68 billion copies of the same segment. If we continue to increase up to 40 cycles - we will get over a trillion copies!
On the one hand, PCR enables the identification of genetic material in an efficient, simple and accurate way. On the other hand - due to the exponential nature and high sensitivity of the method - "positive" findings do not necessarily indicate something of biological or clinical significance. In fact, it is well known and well documented that with covid patients a positive result was obtained even after several months from the first diagnosis and when they had already recovered a long time ago. The method is also prone to error in that any slight deviation in the process (and such are always present in biological systems) will amplify the "error" in the signal. The greater the number of amplification cycles (Ct), the greater the chance of false positives. There is widespread agreement among scientists in the field that an amplification of 40 cycles or more makes the test too sensitive and in fact many scientists claim that the maximum value that should not be exceeded should be ± 32. Furthermore - the inventor of the PCR technology - Cary Mullis, who won the Nobel Prize for his work, has publicly claimed many times (unfortunately he passed away just before the outbreak of the covid) that the PCR technology is not suitable for use for diagnosis of diseases and is only suitable for research or as an aid in diagnosis. There is a famous quote by Mullis who claims that with PCR you can " find anything in anyone ...". These are some of the reasons why even the World Health Organization does not accept the diagnosis of corona based on a PCR test alone (see chapter 10). There are many more potential technical problems with the PCR test but we cannot list them all in this article. The important point is that the number of amplification cycles - Ct determined in the test protocol directly affects the sensitivity of the test and the proportion of samples that will come out positive, and as mentioned, there is widespread agreement that a value of 40 or higher will result hypersensitivity. As you saw in the above protocol - the manufacturer instructs to use 45! amplification cycles.
In the protocol there is a chapter on the interpretation of the test results and there it appears as follows:
That is - if a positive reading (of the amplified genetic material) was received in a number of cycles equal to or less than 40 - the result is positive for covid. I checked the protocols in other kits and in all of them the instructions were similar - of at least 40 cycles. I have not found any manufacturer that recommends amplifying only 32 cycles. The differences between test kits is in the genes used as a target for detection.
This is a clear proof that they deliberately followed a diagnosis method that would lead to a state of over diagnosis.
Precisely for this reason, it is important not to rely solely on the PCR result during diagnosis, and as we saw earlier - the World Health Organization specifically addressed this point. And not only the World Health Organization, the test manufacturers also explicitly write that one should not rely solely on the test result and other factors must be taken into account.
And on this occasion we will also note the other disclosure and warnings that the manufacturer of the test kit has -
The disclaimers are not limited to a particular manufacturer and similar disclaimers can be found with other manufacturers as well. Here is an example from another manufacture-
Therefore, beyond the clear guideline not to rely solely on the test result when determining the diagnosis, the manufacturer indicates that there is no correlation between the Ct value and the amount of pathogen in the sample (contrary to the well-known concept of "viral load") and that other factors may affect the test result - including the use of medications , other infections, etc.). Another important point - the manufacturer states at the end that the accuracy of the test was based on a limited number of clinical samples.
What does that actually mean? This brings us back to the first chapter of this series, where we went over the importance of the validation process of any medical diagnostic test against the "gold standard". As recalled in the freedom of information request, the Ministry of Health was asked to specify against which gold standard the PCR tests were validated. The Ministry of Health did not provide any such information . It only referred to the internal control process of the test kit that is supposed to give an indication of the integrity of the test kit.
So to answer the question of validation against a gold standard - One of the following two options is true - either the Ministry of Health chose to ignore it and therefore answered something completely different, or it does not have any such information and therefore did not answer the question itself. In any case, it shows lack of proficiency in the MoH.
Since the subject of validation is important, I went and looked for information myself at the manufacturers protocols. In the protocol of one of the test kits I found a brief explanation about how and against what it was validated -
It turns out that the validation was done against another PCR test that had previously received the EUA. That is, no validation was done against a gold standard, as explained in the first chapter (on the basis of Koch's postulates), rather, they simply took a PCR kit from another manufacturer and compared the result to it. What does this means?
It's like they would develop a test for the sex of the newborn at the beginning of pregnancy based on tossing a penny coin (50% accuracy guaranteed...) and instead of validating the test at birth, they would do it against a Shilling coin toss...
To conclude the chapter and understand how naked the king is, I recommend the reader to go and read this article .
The article briefly explains the technical problems that make the PCR test completely implausible as a covid diagnosis.
In two short points for those who do not have time to read the above article:
The first approved test kit (probably against which all the validations were performed as described above) - was developed by the German Christian Drosten. Drosten, published an article in which he detailed how he designed his PCR test (this article was peer-reviewed and published within 24 hours! An unprecedent event in the scientific literature...). He admits that he did not have an isolate of the new virus in his possession when designing his PCR test! How then and on what basis did he knew how to design such a specific test? It turns out that he guessed or assumed (yes, yes! Real! - it is written in the article itself) that it was a Corona virus and thus he had a basis from which to start the designing of the primers. Sounds scientific and convincing? You decide...
It turns out that the same primers designed by Drosten has remarkable similarity to parts of the human genome. One of the primers is almost identical to a segment of the human genome! What are the consequences of this? Could it be that it guarantied many positive results as these tests were rolled out?
To conclude this chapter -
There are many problems in the way they chose to apply this technology for the purpose of diagnosing covid exclusively and without considering other data and especially the clinical findings of each subject. The very problematic design of the test kits, their lack of standard validation, the disregard of the clinical findings in the background, the assumption that everyone must be tested, including perfectly healthy people, and the calibration of the tests to be super sensitive - all of these allowed the number of "cases" to be inflated beyond all proportion and to the creation of a false narrative of a worldwide pandemic and of a disease that spreads like wildfire. The PCR test detects the presence of a piece of genetic material. It does not find a complete and functional virus. The exponential nature of the amplification of the genetic material makes it possible to turn the test into an inflationary tool that produces a huge amount of "cases" when the limit is only the maximum number of tests that can be performed per day.
The general public, who is not familiar with the above details, is convinced that this test is the gold standard for diagnosing covid, but in fact the situation is 180 degrees opposite - the PCR test has never been a gold standard and has never been validated against a gold standard. Only when you get down to the details and look with a skeptical eye will you find out how much it relies on a broken reed.