Good sleuthing Girlie and others. I agree it was probably ELISA.
The CDC wants the medical industry to follow its CASE SURVEILLANCE DEFINITION METHODOLOGY for testing for Lyme disease and offers no other means for testing. This is problematic on many levels as the tests have been studied to be about
50% reliable. The CDC reports that
Lyme is the fastest-growing infectious disease. Yet, find ANY other infectious disease where the tests promoted by the CDC are 50% reliable.
A misconception about
Western Blots is that they have as many false positives as false negatives. This is not true. False positives are rare. The conclusion of researchers was on this issue was: "the proposed Western Blot Reporting Criteria are grossly inadequate, because it excluded 69% of the infected children."
1995 Rheumatology Conference in Texas. (1995 Rheumatology Symposia Abstract # 1254 Dr. Paul Fawcett et al.)The table mid-page of this article by the leading LD organization indicates the frequency of “false positives” (high specificity) and “false negatives (low sensitivity) – the two-tiered testing misses 44% of positive cases:
www.ncbi.nlm.nih.gov/pmc/articles/PMC2078675/ A fundamental problem with the CDC's serology tests is that they look for evidence of the immune function's response to the Borrelia burgdorferi microbe. However, over 200 studies show that Bb can disable the immune response once the microbe is in the body. Over 700 articles support these findings:No serological test can rule out LD and LD cannot be adequately diagnosed by serology alone. Studies show potent immune suppression induced by Borrelia, which interferes with an appropriate immune response by design so most people don’t produce enough antibodies for the tests to register.
(Elsner RA, Hastey CJ, Olsen KJ, Baumgarth N (2015) Suppression of Long-Lived Humoral Immunity Following Borrelia burgdorferi Infection. PLoS Pathog 11(7): e1004976. doi:10.1371/journal.ppat.1004976) journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1004976If this spirochete is evolved enough to attack our B-lymphocytes, then it may also be evolved in other ways that we do not yet understand. It is for certain that its ability to kill B-lymphocytes evolved as part of a defense mechanism to evade its own destruction. The observation that it can use the B-cell's own membrane as camouflage indicates that it may be able to go undetected by our immune system. The way our immune system is supposed to work is that it recognizes foreign invaders as being different from self, and attacks the infection.
(The Complexities of Lyme Disease: A Microbiology Tutorial: Part 1, By Thomas M. Grier, MS, Excerpt from the Lyme Disease Survival Manual 1997.)www.lymeneteurope.org/info/the-complexities-of-lyme-diseaseThe structure of the Lyme spirochete is unlike any other bacteria that has ever been studied before. Spirochetes have an extra layer of glyco-proteins may act like a stealthy coat of armor that protects and hides the bacteria from the immune system. The human immune system uses proteins that are on the surface of the bacteria as markers, and sends attacking antibodies and killer T-cells to those markers, called outer surface protein antigens (OSP antigens). This nearly invisible layer is rarely seen in washed cultures, but can be seen regularly in tissue biopsies.
(Sigal LH, Tatu AH. Lyme Disease patient's serum contains LgM antibodies to Borrelia burgdorferi that cross react with neuronal antigens. Neurology 1988;38:1439-1442) www.lymeneteurope.org/info/the-complexities-of-lyme-diseaseThe other fundamental problem with the CDC's testing methodology is that it was NOT created to be a diagnostic methodology:CDC’s CASE DEFINITION METHODOLOGY relies on a two-tiered decision tree or screening process that serves its disease-tracking purposes - not capturing all cases but by finding cases that are highly similar. Therefore, the methodology MDs are told to follow and the criteria the CDC uses for interpreting the results are very strict. Again, the purpose of the surveillance process is to find the similar cases - not find all the cases.
Even the CDC clearly states on their website (albeit really hidden well) that the tests should not be used solely to diagnose but that Lyme is a clinical diagnosis. Some states have required labs to put this disclaimer on the test results, too... but MDs still use them solely to diagnose (likely because they are ill-informed and also unqualified to clinically diagnose).
www.cdc.gov/lyme/healthcare/clinician_twotier.htmlWhat is this two-tiered testing? - 1st tier test ELISA (Enzyme-linked Immunosorbent Assay) with confirmatory 2nd tier test Western Blot (immunoblot). These are both serology tests that rely on detecting antibodies produced by a healthy immune system. Over 200 studies confirm that the Borrelia microbe can and does disable the body's immune response, which is one primary reason the tests are unreliable.
- So, the CDC recommends MDs start with the 1st tier ELISA test, which is a very general test intended to detect general immune activity (looks for a collection of the B31 strain antibodies), not a response to a specific infection. The theory employed by the CDC is intended reduce ‘false positives’ since the ELISA can show positive reaction to antibodies associated in people previously vaccinated for LD.
(Virginia Governor Bob McDonnell and Secretary of Health and Human Resources 2011 Lyme Disease Task Force Report)www.cga.ct.gov/2012/rpt/2012-R-0149.htm (Molloy, Berardi, Persing, Sigal Detection of Multiple Reactive Protein Species by Immunoblotting after Recumbant Outer Surface Protein A Lyme Disease Vaccination)
m.cid.oxfordjournals.org/content/31/1/42.full - MDs are told that if the first tier (ELISA) is negative, that the patient doesn't have Lyme and move on to a more appropriate diagnosis. In 30+ years, the CDC and the IDSA have failed to adequately explain this methodology, given the hundreds of studies that prove Lyme can disrupt immune function and the CDC's tests are only 50% accurate.
- Knowledgeable MDs and LLMDs know to ignore the CDC's methodology (although some still test first w/ ELISA due to insurance demands) and follow up with Western Blot, ESPECIALLY if the ELISA is negative. That's how I got my WB CDC-postitive result - my ELISA was negative.
- The WB is more specific for Lyme so it looks for more evidence that the immune system has responded to it, looks for more antibodies. Now, some people still won't develop enough antibodies to produce a positive test - in fact, it's pretty well known that the sickest people often produce negative tests. However, the CDC has created such strict criteria for the WB, that half the time it produces false negative results. Again, the criteria is geared toward Surveillance data purposes to detect cases that are similar to each other---but often leave out all the other manifestations of the Bb microbe. This is also where people fall through the (ginormous) crack.
Also -
Despite the irrefutable fact that Bb can deactivate the immune response, CDC SURVEILLANCE CASE DEFINITION criteria includes specific requirements for an immune response to a minimum number of certain WB "bands".
Again, this
“qualifying bands” criteria for the two-tiered testing methodology is intended for surveillance purposes, only, and was not intended to be utilized in confirming the presence of the infection for effective diagnostics purposes. But the CDC promotes it and MDs use it anyway. There are three primary ways the WB can be interpreted incorrectly by MDs:
- 1) Most MDs order both IgG and IgM tests. IgG typically indicate old antibodies (older infection) and the IgM typically indicates new antibodies (newer or reactivated infection). But these rules also generally don't apply in the world of Lyme since it's broadly understood that Bb can disrupt normal immune function, these distinctions aren't helpful. Regardless, an MD will tell people who are CDC-positive for IgG that it's an old infection and the immune system has already taken care of it, evidenced by the old antibodies so their current sx cannot be caused by Lyme. "You don't have Lyme".
- 2) The strict interpretation criteria requires reaction to a minimum of 5 specific IgG bands and 2 specific IgM bands. Some of these bands can be cross-reactions of different infections but some are Lyme-specific bands. Generally, if you react to a Lyme-specific band, it's a positive test result, regardless if you reacted to all of the CDC's list of 5 and 2 bands. You can't be sorta pregnant. This is yet another reason for the inaccurate results where MDs tell patients they don't have Lyme because they didn't react to enough bands.
- 3) Additionally, two specific Borrelia components/DNA (OspA or outer surface protein A) were used to create two early vaccines developed in the 80s. Subsequently, the CDC and IDSA REMOVED the OspA bands 31 and 34 from the possible Lyme-specific bands the body can react to in order to avoid cross-reaction by those who received the vaccine. I really can't explain why they did this - it's non-sensical and yet another reason for the inaccurate results and abundance of false negative results. This is also why it's recommended to use an IGeneX WB test which includes the 31 and 34 bands in the results and why the IGeneX is more reliable (it also has a more accurate lab process). You can read more about
it on their website.
Here's more info about
these two bands and what happened in the Dearborn meeting:
"Prior to a 1994 NIH hearing to develop conformity amongst labs, every lab accepted bands 25, 31, and 34 as Lyme-specific and significant in diagnoses. Without any clear reasoning, the NIH disqualified those bands from being reportable. The result was that what had been a fair good test had now become poor or even useless."
(1995 Rheumatology Conference in Texas. (1995 Rheumatology Symposia Abstract # 1254 Dr. Paul Fawcett et al.)When the CDC developed its surveillance case definition it included specific requirements for certain "bands" to be present on the confirmatory western blot. However, two “Lyme-specific” bands (kDa 31 and 34, or osp—outer surface proteins—A & B) were excluded. Why? These bands are so specific for LD that they were used for vaccine development. They removed them from the testing criteria otherwise people who had been vaccinated would all be positive for those bands and falsely positive on tests.
www.lymeneteurope.org/info/the-complexities-of-lyme-disease Because the CDC eliminated the two bands from their qualifying list of “CDC-positive” bands, some people who DO have lyme and have a reaction to those bands (yet were never administered the vaccination) yet lack reaction to enough bands will be considered “negative” for LD. Not only were the vaccinations unsuccessful, the venture now leaves the primary testing methodologies without lyme-specific bands, which would help test accuracy.
OK - that's more than you wanted to know about
the testing but maybe it's helpful in some way. ;)
-p
Post Edited (Pirouette) : 7/28/2017 4:38:53 PM (GMT-6)