The Problem of trying to determine SARS-CoV-2 infections using PCR Tests (19-min video)
In Germany, a group of lawyers have formed the independent Corona Committee for the purpose of gathering factual evidence about the pandemic in order to legally challenge the authorities as to the suitability of the continuing measures.
This video is an edited abstract of the live stream coverage, focussing only on the part of the evidence concerning the controversial use of PCR tests in an effort to measure numbers of new infections.
To make this abstract accessible to english language speakers, english sub-titles have been added.
UPDATE - HERE is the video transcript:
The problem of trying to determine SARS-CoV-2 infections using PCR Tests
In Germany, an independent “Corona Committee” has been set up. A group of attorneys are collecting evidence in order to mount a legal challenge to the government’s measures. Details in English can be found here: https://corona-ausschus.de (the English doesn’t seem to be working).
Questions write to kontakt@corona-ausschuss.de
There will be several hearings taking ‘evidence’ from experts. The 4th hearing took place in Germany 23/7/2020.
This video is a selected edited extract of the hearing with English subtitles.
Topics covered: PCR tesing (type of test developed by C. Drosten); Immunity; and the “Second Wave”. This video will cover only the discussion about the testing.
Important Finding from the Test Discussion
- The tests being used everywhere to determine cases (the measure commonly taken to mean that a person is infected) are not fit for purpose.
- Only a clinical diagnosis of a person’s symptoms by a doctor can reliably show if they have been infected.
Woman Participant (unified in video): Welcome to the 4th meeting of the Corona Committee. We are concerning ourselves today with the urgent question about the reliability of the PCR testing. We have guests here and I’ll explain shortly who they are. I’d like to welcome Frau professor Kammerer. She is a virologist and immunologist. I’d like to now hand over to Dr. Wolfgang Wodarg.
Dr. Wodarg: Good morning, Frau Kammerer. This is great you are able to explain our technical questions. You have a considerable practical experience handling the diagnosis and evaluation of immunological results and this is very important because we want to understand the basis of these immunological tests. It is the basis on which the local health authorities are continually making decisions. Sometimes one has the impression that the awareness of what the results of these tests really mean in not really so well understood, and this has for us is having a really big impact on the economy and the fate of the people who are losing their employment.
Dr. Kammerer: As already said, a PCR diagnostic test is not any kind of immunological tests but can only evidence the presence of nucleic acids .
Dr. Wodarg: Yes, I find it quite important that one is aware that this PCR test, it multiples only a certain sequence of defined molecules.
Dr. Kammerer: It multiples only a small section of genetic material from a selected region of the virus without being able to tell whether the complete virus is at all present. I believe this is very important to know.
Dr. Wodarg: So when the whole virus is not present but only fragments of it, will these be detected in the test and give a positive result?
Dr. Kammerer: Exactly, when these tiny intact fragments are present they will be detected as a positive result.
Dr. Wodarg: That means that there is no bodily reaction being measured. The test is not measuring what is happening to the person tested. It is just telling you that such a fragment is lying around.
Dr. Kammerer: You measure exclusively whether there is a nucleic acid present. This is comparable with a forensic scientist searching or traces of genetic material; but, this has nothing to do with whether living cells, an active virus or an illness is present.
Dr. Wodarg: So this test cannot confirm an infection? An infection is the reaction of the body.
In the background: This is really really important.
Dr. Wodarg: Yeah.
Kammerer: So the test can confirm the presence of nucleic acid from the virus in the subject when the test is sufficiently specific, but it can not yet say if the virus fragment detected is active and capable of replication, or if it is actually replicating and cannot say anything about whether the test subject is infected, ill with the virus. It is a correlation, so when someone is ill AND has signs of a cold AND a high indication from the test of the presence viral nucleic acids… then the probability is very high that the virus is actually present. But for the positive results where symptoms are not present, nothing can be said about the presence of an infection (high viral load).
Wodarg: One cannot really say that they are ‘infected’ because ‘infection’ refers to a reaction in the (human) body.
Kammerer: Quite right, it proves that there are traces of the virus RNA on the test swab but it does not prove that there is an active virus present which is able to reproduce. That cannot be established with this test.
Wodarg: This is the PCR test, that is the test that is being applied everywhere with a swab and from which conclusions about the extent of infections are drawn.
Male participant (unified in video): Frau professor Kammerer, this is from my perspective, in any case an incredibly important piece of information, which I believe 99.9% of the world population is unaware of as they try desperately to wear their masks. The only reason for the present wave of panic is what we hear from the media, at least in the US, when I spend much time, are the repeated flood warnings about the numbers of infections. Have I got this right that these PCR tests, if they prove positive, provide evidence of the presence of molecular fragments or other debris but not necessarily provide evidence that an infection is present?
Dr. Kammerer: That’s right. One must have been in contact with the RNA molecules of the virus but does not mean a person has had exposure to sufficient amounts of the virus to make them sick. There are PCR test for AIDS etc where you do this and you define a level of sensitivity at which you can say the virus is present. But with the presently available PCR tests, it’s not possible to deduce this given the way the SAR-CoV-2 is assessed.
Dr. Wodarg: The required validation of these tests, when on uses the PCR test and wants to say something about an infection, is that at all possible? Can the test be validated such that it is possible to confirm the presence of an infection?
Dr. Kammerer: You could naturally say, we have infected patients from whom you could make a virus isolate as is done with other viral diseases. The PCR test works logarithmically ie the initial nucleic acid fragment is amplified by the test 1-2-4 times etc. Normally, after about 20-25 amplification cycles there is enough viral RNA present to say there must be a certain viral load present. But then with such patients this approach needs to be validated and confirmed by getting a direct virus isolate. And I have, up to now, not found anything in the literature to say that this has been done.
Dr. Wodarg: This is what I believe the EU requires of a test to give a reliable diagnosis.
Dr. Kammerer: Ring tests normally need to be carried out, so that they get samples from those where they don’t know if something is present or not and only the diagnosis collection centre know who is really infected; and they must report back, positive or negative, weak positive etc. and this is not happening.
Another male participant (unidentified): Could you perhaps just again explain exactly what is involved in carrying out a PCR test?
Dr. Kammerer: So, a PCR test is the so-called Polymerase Chain Reaction test. You make use of it to multiply the nucleic acids present in the sample using special enzymes. That is what the cells do anyway when they either split or multiply this basis RNA to create proteins. And for that Kary Mullis received a Nobel prize. He found an enzyme which can be used again and again to do this amplification process. And they isolate the nucleic acids from the virus. Write down the gene sequence with for Coronavirus is an RNA sequence which has to be transcribed into a DNA sequence and then they start the process in which small nucleic acid pieces are selected, the so called ‘primer’ which fit to the sequence. That assumes of course that they know already what they are looking for, so they must have this sequence to determine these mostly 20 pieces of nucleotide to create in a computer. When you do not know what you are looking for you loot for a near relative of the virus as has happened in this case. There are enough bat corona viruses and SARS. All these prior, known viruses are very similar. And so one looks for these, quasi recognizable pieces. Two pieces, which are at a distance from each other, in this case, by 80 to 200 nucleotides. And there on these small pieces when they bind to the known sequence, the multiplication process can start. And in the technology system used in modern diagnostic tests, it is such that a third piece which is lying in the middle of the ‘amplified’ gene section is identified with a fluorescent marker. And every time when the SARS-Co-V-2 pieces are multiplied, this third piece is dismantled a colour signal is given off. And then the whole process repeats itself again from the beginning. All three pieces attach onto the nucleic acid, this enzyme works over it again like a kind of zip that goes backwards and forwards and each time performs a doubling and then there is another colour signal and so on. And this colour signal can be read by modern instruments and the earlier you have a well confirmed colour signal, the more amplified pieces of the nucleic acid you will have in the sample, and one says that when, for example 25 such repeats have happened, there’s a lot of nucleic acid present and the sample is “positive”. So when only after 50 cycles of amplification you get the colour signal then that is a false or “negative” result.
Participant asks: So that is the only thing this test can tell you when it gives a positive result?
Dr. Kammerer: Correct. With this test you can only evidence that these multiplied fragments of the virus are present in the smear sample taken from the test subject but nothing more. You cannot go so far as to say there is an illness resulting from an active multiplying virus in the patient. You can only postulate this.
Participant asks: And that is important for me because I believe the majority of the public and all the observers here are impressed about how all this technology works. And for all these people the result is important and for me the result says (unless I have misunderstood this) that all the positive tests which in the USA are being used as a kind of ‘flood level indicator’ in reality are giving no indication of whether people really are infected or even ill with the virus.
Dr. Kammerer: That is right. But with one qualification. When the PCR test shows a positive very early (in the replication) that tell you that the person has the complete virus in them. This is simply a problem about where you set the so-called ‘cut off’ level for the test. And in the work being done this is mostly not defined, this so-called ‘cq ct’ value should be specified but it is never reported which PCR test and under which specifications these positive results being obtained and for this reason you just cannot read anything from the results. It’s like trying to deduce something from looking at tea leaves in the bottom of a cup!
Dr. Wodarg: There has to be a certain level of certainty for deciding what measures are needed. I must ask myself about the person who I am examining. I am making an intervention, even when this is just taking a swab; then, I must consider as a doctor, that the patient (and this is something for the attorneys) is going to ask me. With what are you going to examine me? What consequences is this going to have for me? What method are you using? How safe is this? And what will the result mean? and we have according to the new ‘Infection Protection Law’ the one which has been very quickly introduced. We have an empowerment from the Ministry of Health to deploy non-medically trained people to places to carry out these tests. We saw this in the meat factory that soldiers were used… Yes, but these are legal questions which Frau Kammerer cannot answer.
Participant says: That’s right… This is something we can discuss with each other or with the appropriate administrative people but is not something for Frau Kammerer. For me this was the shocking revelation because now I really cannot understand what this is about.
Woman Participant: It would be good if we could just go back to the scientific basis. We heard from the USA that other sequences are being used and to this connection I’d like to share some information we got from laboratories, from a couple of laboratories we have talked to. It seems that these laboratories have partly designed the tests themselves. Apparently, any medical biologist can do this, by using the instructions fro the Drosten test, FDA or the CDC test etc these labs can adjust as they see fit with the appropriate reagents, so they can make their own in-house tests.
Dr. Kammerer: This is the most benal and basic work in modern laboratory. PCR tests are used for everything. I simply go into the data bank, look for the virus sequence, and make my primer using a primer BLAST and then I make my own PCR and check it which any Bachelor or doctoral student or molecular biology can do . This is done routinely every day. Once you have a corona PCR sequence anyone can put this together.
Woman Participant: So this means we have a much broader spectrum of tests in use that just the 300 commercially available variants. And for these we don’t know the sequence or the cut off point you referred to. In addition, we have various labs making their own tests which are in use but not validated. And we’re not able to know if they all apply the established fixed sequence framework which all are absolutely expected to follow.
Dr. Kammerer: You cannot have this one ‘target’ sequence. As I said already there are various stems and mutations. So you will never find a single SARS-Co-V-2 virus with a fixed sequence. This is an impossibility.
Up to now, nobody was interested in corona viruses. That is the problem. They come very year with the flu season. It always was and always will be, in various forms. Coronaviruses were always regarded as those banal cold viruses.
Colds come and colds go and there was no interest in this expensive diagnostic work other than for a few special groups. I want to be quite clear. Corona was on nobody’s radar other than with SARS and MERS. Otherwise, there is very little data about coronavirus from the work on flu epidemics. They were only previously regarded as unimportant.