Dr James Schaller
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Why the Elisa Lyme Screen Test is Not Worth
The Merit Offered to Dung at a Horse Show

A Guide to CDC and "Infection Expert" Ignorance

When you repeatedly see your children, friends and relatives almost die from the ignorant and freakish CDC position that a junk ELISA screen test can evaluate Lyme, and you hear cult-like mindless medical puppets saying the same thing, and seriously hurting relatives, my kids and others. It is time to call poor medicine to task. It is murder. You can kill people with the best intentions.

  1. First off, in the experience of Dr Charles Ray Jones, who has 9,000 pediatric patients with Tick-borne infections, the bulls-eye rash is in only 7% of his patients. According to the chief of the Lyme research center in Columbia University, no one has the experience of Dr. Jones in this field. Period. Also, I have been collecting these types of rashes and they have about 20 different appearances. They can be almost invisible on some skin types or body locations. Spirochetes do not read simplistic Ivy League medical books, , so they do not always appear in easy to recognize clique rashes..
  2. We repeatedly see children and adults with serious emotional and physician findings of Lyme and other tick-borne co-infections told, "Gee, if I was going by your symptoms and signs, and we have ruled out everything, I would think you had Lyme. But your Elisa test came back negative, so it is impossible to have Lyme." I am going to be sick. Since when did physicians give over their minds to laboratories with very poor blind Lyme test results? Did they get hit in the head? Did some cult authority tell them to ignore clinical realities and leave possible hundreds of thousands or even millions ill?
  3. Some members of the anti-care Lyme community like to say that IGeneX only makes positive results. This is utter nonsense and the San Francisco Chronicle spanked the CDC for such ignorant allusions to this lab, informing readers IgeneX scored 100% on blind negatives. Let me be very clear. Every negative sample was called negative by this elite lab. IGENEX called all negatives as correctly negative. Yet, expect to keep hearing this because cults are good at chanting.
  4. In patients with no bulls-eye rash–you know, the rash that assumes people get naked everyday and go over their body with an electron microspore--the CDC rejects clinical signs and symptoms and requires a positive screen test called an ELISA. The non-clinical CDC, in their papal surveillance criteria for Lyme, has ruled that a negative ELISA means you do not have Lyme.
  5. Practice guidelines developed by the NIH and the Infectious Disease Society of America (IDSA), hardly cutting-edge Lyme groups, advise physicians suspecting Lyme disease to make a clinical diagnosis.
  6. The CDC is confused in their communication from one season to the next. In its own public statements, the CDC says it has not issued guidelines for diagnosis of Lyme. It seems many infection doctors and other physicians struggle to read this due to English struggles.
  7. The CDC explains that they are only interested in the exacting world of research. This IVY Tower world has nothing to do with whether my child will become injured following their double talk and unclear statements. You see they just want to do "surveillance." When was the last time you used this eccentric word? It seems to mean that they want to know how many certain West Nile cases occurred in a state. A test which looks at 20 dead birds with West Nile and finds a positive in a few of them is good enough for surveillance. Of course this is about dead birds and not fragile human life. Unfortunately this "surveillance" idea seems to have been lost on most doctors, or they simply do not care about the distinction between state surveillance research and the child in front of them. This surveillance concept seems outside medical school training or the memory of many physicians.

    A CDC representative made the distinctions clear at a hearing in Connecticut in 2004: "Surveillance case definitions are created for the purpose of standardization, not patient care... Whereas physicians appropriately err on the side of over-diagnosis, thereby assuring they don't miss a case, surveillance case definitions appropriately err on the side of specificity [to only get a small number of certain and "pure" cases].
  8. Many physicians and patient advocates have reported clear and certain bulls-eye rashes, and then they report repeated and relentless negative ELISA results. In the unreal word of the anti-clinician this should not happen, but when you are locked in a lab, you could miss a nuclear apocalypse.
  9. According to exceptional research on the Elisa test, published in Journal of Clinical Microbiology, in 1991, 55% of laboratories could not accurately identify serum samples from Lyme disease patients containing antibody against Borrelia burgdorferi. The purpose of this study was to determine whether the accuracy of Lyme disease test results reported by approximately 500 participants in the Wisconsin State Laboratory of Hygiene/College of American Pathologists Lyme Disease Survey had improved. From 1992 through 1994, 50 serum samples were sent to participants of the survey. Each laboratory received 28 serum samples from individuals with Lyme disease according to the case definition of the Centers for Disease Control and Prevention and 22 serum samples from healthy individuals. Unfortunately, the serodiagnosis of Lyme disease by participants had not improved. These results suggest that stronger criteria must be applied for approving and continuing to approve commercially available kits for the serodiagnosis of Lyme disease.

    [Bakken LL, Callister SM, Wand PJ, Schell RF. Interlaboratory comparison of test results for detection of Lyme disease by 516 participants in the Wisconsin State Laboratory of Hygiene/College of American Pathologists Proficiency Testing Program. J Clin Microbiol. 1997; 35:537-43].

**Other studies show equally chaotic sloppy test kits, served up to clinicians and patients as quality lab testing, but far too much like a drunks attempt at fine needlepoint.

From 1999 to 2001, between 226 and 337 microbiological laboratories participated... Test results were found to be ...highly variable... In view of our results further standardization of Lyme disease serology is not just desirable but is urgently needed. Moreover, stronger criteria for the validation of available test kits must be applied.

Hunfeld KP, Stanek G, Straube E, Hagedorn HJ, Schorner C, Muhlschlegel F, Brade V. Quality of Lyme disease serology. Lessons from the German Proficiency Testing Program 1999-2001. A preliminary report. Wien Klin Wochenschr. 2002;114:591-600.

**The serologic test for the detection of antibodies to Borrelia burgdorferi is the most frequently used laboratory method for the diagnosis of Lyme disease. However, the insensitivity of the assays and the interlaboratory variability are frequent problems. To determine the extent of this variability, one aliquot of serum from each of nine patients with a history of Lyme disease was sent to nine reference laboratories, including national, university, state, and local hospital laboratories. A second aliquot of the original serum was submitted 2 weeks later. Wide variability among laboratories was observed, ranging from a university laboratory that detected antibody to B burgdorferi (IgG or IgM) in 18 of 18 specimens, to a state laboratory that detected antibody in only 8 of 18 specimens. Detection of IgM specific antibodies showed similar variability (range, 2 to 10 of 18). There were eight instances of a fourfold or greater change in titer between the aliquots sent 2 weeks apart, although only three of these were an increase in titer. These results indicate the need for standardization of the assays and the availability of national reference material. It is recommended that the results of serologic testing should not be relied on as the sole criteria in making the diagnosis of Lyme disease.

Luger SW, Krauss E. Serologic tests for Lyme disease. Interlaboratory variability. Arch Intern Med. 1990;150:761-3.

According to many physicians, I should now be defrocked for making these types of statements, since I am not part of the cult that harms vast numbers by their profound ignorance about Lyme. Years ago, I was taught by all-knowing sages that ulcers were due to acid and an infectious cause was comical. I wonder how many died of ruptured ulcers that bled to death from these "experts"? HIV information was delayed for years due to similar ignorance. When I had to tell upper level security staff if they were exposed to anthrax in dealing with powdery packages with Arabic writing on them, the government was late in giving guidelines. I had to treat immediately. They are late again in a Katrina-like medical manner.

I have followed the common good little boy position on Lyme, and it caused serious and savage results in my family. If some state board, medical society, department of health sadist wants to come after me, I will be content in the knowledge that the small minds I oppose almost killed many of my loved ones and I prevented their teachings and policies from doing so. And I shall resist their sincere and dangerous 1970's medicine firmly, as they say stupid and useless and ignorant things like, "Florida has no Lyme disease." Of course not you fool, you never test for it, you never read about it, and if you do you use a lab junk kit, we know it is going to be negative based on experience using it on well-established advanced and repeated bulls-eye rashes.

By the way, Lyme bacteria have over 20 ways to hide from the immune system and to beat lab tests, but that would be real clinical science, and we are still in the diapers stage.

Dedicated to the dead who lost their lives from Lyme while being given a hundred other diagnostic labels. If they often operate on the wrong limb, you really think they can get the massive complexities of Lyme bacteria? And what drug company has a Lyme product? So why fund this research? So no real education is being done since there are not any new Lyme drugs. Medical education is based on new pharmaceutical medication options.

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