The testing validity measures sensitivity and specificity are both referred to with regard to testing and depending on which you are speaking about what is said about the test may sound very different and confusing. In this case I am talking about the C6 Elisa test and when I speak of the validity of the test I basically mean does the test accomplish what it sets out to do (i.e. is it an accurate test).
So with the C6 Elisa its around 50% sensitive (in the context of the two tiered testing system on its own it has a sensitivity of 75%) because it misses about half of true positive cases. Meaning 50% of the people tested who do have Lyme will test negative. So your odds of testing positive are about 50%. Not great at all, about the same as flipping a coin.
So with the C6 Elisa it has a Specificity 98.5%, it is very specific and only comes up with a false positive result 1.5% of the time. Meaning if you do happen to test positive for Lyme it is highly probable that you do in fact have Lyme because the test doesn’t often make a mistake of identification. – Excellent.
So you can see if you are talking about the C6 Elisa Specificity you will say it’s excellent but if you are talking about it’s Sensitivity you could say its terrible and both would be true. Sensitivity and Specificity are relative terms so ideally for a test to be very valid you would want it to have both high Sensitivity and Specificity.
Also keep in mind that these numbers are not taking into consideration the large percent of Sero Negative patients who would have been excluded at the outset of analytical testing making these numbers in reality much lower. These numbers are just to give you an idea of the state of testing but it is important to note that the case definition needs to be changed first to encompass all of us with lyme in order for any change in testing to be of real value. If the samples being used to validate the testing are only from people with the HLA genes (the people who test positive on traditional testing) you can see how this would skew all the results so its paramount that the case definition be changed to include all sero negative cases as well as as describing Neurological Lyme as it truly is first and then to move on to testing).
I find parables helpful so this is an example I made up to help clear it up (Keep in mind this is just an illustration to help you visualize the difference between Specificity and Sensitivity).
So say there are 6 people fishing in a pond full of bug-eyed-brown fish. All 6 fishermen are trying to catch this specific type of fish. They have heard that the bug-eyed brown is very attracted to the flint worm and has great success in getting the bug-eyed-brown to bite. So imagine the flint worm on the hook is the test and we want to know if the test is valid and if it does what it intends to do (in this case lure bug-eyed-browns to bite the worm/hook). After an hour of fishing 3 of the 6 fisherman hooked the right fish the bug-eyed-brown and the 3 others hooked nothing. The specificity is 100% because it only attracted the right kind of fish each time it managed to hook one and never attracted the wrong kind of fish (so 0% false positives) but the sensitivity is only 50% because 3 of the 6 times the flint worm wasn’t able (or sensitive) enough to catch it at all (so missed 50% of true positives).
Problematic areas of Lyme testing
First Tier ELISA:
As stated above the Elisa has terrible sensitivity and misses at least half of true cases of lyme. This is a big problem, and this fact alone should exclude it from being used as a screening test because screening tests are to have 95% accuracy and it is far from that. The fraud comes in when you look at why this validity measure uses 5 standard deviations above baseline noise for a positive when the standard for testing measures is 3. The idea is to capture the lowest level of the analyte in question, not the highest. They have purposely increased the cut off to miss everyone who has neurological lyme (the 85%). This test is only good for people who have an autoimmune HLA link to Lyme disease (approx 15%) as these people are genetically predisposed to produce more antibodies and therefore do not get the immune suppression and neurological symptoms the rest of us get. The people who test positive are ironically the ones who really aren’t sick other than a bad knee (Lyme arthritis). This is how after the Dearborne conference, where the case definition was fraudulently changed to a very narrow set of criteria that lyme came to be associated with arthritis, namely an arthritic knee, when in reality that is the very least of the symptoms most lyme patients encounter.
https://www.ncbi.nlm.nih.gov/pubmed/11532615 These results suggest that the presence and or lack of production of specific antibody to Bb infection may be associated with particular HLA specificities of the Class II.
Nine out of the 22 seropositive LD patients (40.9%) had HLA-DRB1*0701, *0703, *0704 (HLA-DR7); only 1 out of the 18 seronegative LD patients (5.6%) had HLA-DR7 (odds ratio (OR)=11.8, P=0.0126). HLA-DRB1*01021 and HLA-DRB1*0101, *0104, *0105 (HLA-DR1) contributed negatively to anti-Bb antibody production. Seven of 18 seronegative LD patients had HLA-DR1, only 1 of 22 seropositive LD patients had HLA-DR1 (38.9% vs. 4.5%, OR=13.4, P=0.0138). These results suggest that the presence and or lack of production of specific antibody to Bb infection may be associated with particular HLA specificities of the Class II.
In addition, most doctors give this test right away when someone arrives with a tick bite and the body requires weeks to create the antibodies needed to pop a positive on this test so this is a big problem as well. The rationale they use with the two tiered system for adding in the Western Blot is that it will reduce the false positives (people testing positive who don’t have the disease) as you can see the problem with the Elisa is the opposite, that is has a high rate of false negatives (telling people they don’t have lyme when they in fact do) so this in my opinion is a fraudulent scientific message as well when you consider that there is a 50% chance of a false negative and only 1.5% chance of a false positive.
Second Tier Western Blot:
As you can see the Western Blot also has many problems with sensitivity at all stages but especially within the first month and again later on the more chronic it becomes. If you take the terrible sensitivity of both tests in the two tiered system you will start to see how testing positive consecutively on both is very unlikely, mathematically improbable and biologically almost impossible unless you are in the HLA autoimmune group which is comparatively rare. The other bit of insanity with antibody tests like this is that within 10 days of infection the germinal centres where B cells are assigned an immune duty have been shut down. B cells normally mature into antibody secreting cells, however in the presence of lyme they do not mature properly and therefore are functionally unable to produce the amount of anitbodies required to pop a positive. Quote below taken from Suppression of Long-Lived Humoral Immunity Following Borrelia burgdorferi Infection ttps://doi.org/10.1371/journal.ppat.1004976
"Germinal centers (GC) are main immune response outcomes that usually develop in secondary lymphoid tissues after infections. They are required for development of long-lived plasma cells, which provide ongoing protection by continuous antibody secretion. They also induce recirculating memory B cells, which respond quickly to reinfection with differentiation and production of high affinity antibodies . Germinal centers do form in Bb-infected lymph nodes at around two week after infection, but then rapidly involute over the next two weeks .
Here we tested the functionality of the GC responses to B. burgdorferi. We demonstrate that following infection of mice with Bb, GC are structurally abnormal and long-lived plasma cells and B cell memory, normal outputs of GC responses, fail to develop for months after infection rendering mice susceptible for reinfection with the same strain of Bb. When mice were infected with Bb, vaccination with influenza antigens failed to induce protective anti-viral immunity, revealing that Bb-infection actively inhibits long-term humoral immune response development" https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1004976
Additionally due to antigenic variation the bands, which are protein antigens, are able to change their outer surface once the immune system is on to their presence, so the bands are always changing in an attempt to elude the immune system, which means western blotting bands will be different at any given period. How can you test someone using a static measurement criteria such as the CDC criteria for something that is constantly in flux? You can’t!
I liken the two tiered testing for lyme to giving a blind person a vision test then telling them they can see – it’s madness!
Other Lyme tests:
Nanotrap Urine Test:
This is a DNA test and is good IF and only if there happens to be DNA in the urine sample which may or may not be the case. So if found then you can say with certainty that the person has lyme but if negative it is quite worthless much like the ELISA.
Blood Culture Testing:
Lyme is notorious for being difficult to culture and as you can see from the image above taken from J Clin Microbiol. 2005 Oct; 43(10): 5080–5084 that the sensitivity of such methods are low. Blood cultures while definitive if positive are really also quite futile if negative, as Lyme once disseminated does not hang out in the blood as much as in tissues, bone, brain etc.
The Solution Band 41 test.
The band 41 test that is patent owned by Yale reserachers is an excellent diagnostic test for Lyme (See patent below)
Band 41 is highly immunogenic meaning even people with a suppressed immune system as in those of us with Neurological lyme can often still produce this band. Band 41 is also not subject to antigenic variation being the flaggelar (tail) region of the Spirochete. Quote below from J Clin Invest. 1986 Oct;78(4):934-9 . The antigens (bands) are always varying even late in the disease which makes it scientifically nonsensical to use a standard criteria for all but band 41. The emphasis in the quote below is on lyme being “alive” throughout the disease, meaning it is always changing in response to threats from the immune system.
The IgG response in these patients appeared in a characteristic sequential pattern over months to years to as many as 11 spirochetal antigens.The appearance of a new IgM response and the expansion of the IgG response late in the ilnness, and the lack of such responses in patients with early disease alone, suggest that B. burgdorferi remains alive throughout the illness.
In early-stage borreliosis, the 41,000-molecular-weight flagellin protein (41K) of Borrelia burgdorferi was the major antigen detected by antibodies in sera, but the specificity of the reaction pattern was dependent on the intensity of the band. The evaluation of different interpretation rules based on a semiquantitative record of band intensities showed the highest specificity (96%) and a corresponding sensitivity of 78% if there was at least one distinct (optical density range, 0.2 to 0.4) immunoglobulin G and immunoglobulin M reaction with the 41K band.
Consequently there are a few aspects that make it a very good diagnostic test; the fact that band 41 is more immunogenic (causes a more robust immune reaction) and that it isn’t subject to antigenic variation. Additionally, band 41 is one of the first bands to appear and therefore can be used to diagnose earlier in the disease which is an enormous benefit as clearly early disagnosis and treatment is paramount. The sensitivity and specificity are an improvement over current methods and should be utilized. See sensitive and specificity break down from the band 41 test below.
The sensitiv- ity of the two-step process for patients with erythema migrans or with later manifestations of Lyme disease was 64% and 100%, respectively. The specificity for healthy blood donors was 100% and was 90% for the aggregate of all persons with illnesses that may cause serologic cross-reactivity(98% if the samples from relapsing fever patients were excluded). Test precision was 96% overall,99% for Lyme disease case serum samples, 100% for specimens from blood donors, and 88% for samples from persons with other illnesses.
In early-stage borreliosis, the 41,000-molecular-weight flagellin protein (41K) of Borrelia burgdorferi was the major antigen detected by a
ntibodies in sera
One has to wonder why Yale didn’t want to use a test that they patented that would capture the vast majority of lyme patients.
However as I see it if they utilized this test to validate their Lyme vaccine the results would show that their so called vaccine was in fact the opposite of a vaccine and induced the very disease it was supposed to protect the person from, as was the case for many people who were injured by the first Lyme vaccine Lymerix which was taken off the shelf.
I can not fathom any other reason why they would not use a test they owned that has 96% accuracy overall and 100% specificity.
The answer can only be fraud.
For more on testing: https://madisonarealymesupportgroup.com/2017/08/15/reliability-of-lyme-testing/