Friday, June 21, 2013

Lyme Disease Testing Protocols: Lyme Disease test kits and limitations

March 8, 2013

Key Points

 Serologic test results are supplemental to the clinical diagnosis of Lyme disease and should not be the primary basis for making diagnostic treatment decisions.
 Lyme disease test kits have sensitivity and specificity limitations.
 Health care professionals should be aware of these limitations and are encouraged to report suspected incidents, including false-positive and false-negative results, to Health Canada.

 This is an “open letter” to the Ontario Minister of Health. It is also being shared with other persons and groups interested in the issues described herein.

The Newsletter states unequivocally that “false” testing results have occurred as a result of using the two-tiered Canadian laboratory blood-testing protocol as the basis for detecting Lyme disease. It goes on to say that those false reports likely result from the failure to address the “genetic diversity of B. burgdorferi” (the bacterium known to cause Lyme disease) and from failing to consider “cross-reacting antibodies due to other conditions or infections.”

Health Canada’s warnings are clear “admissions against interest” and offer evidence that our federal public health officials now recognize and acknowledge the failings of two-tiered Lyme disease testing. That recognition undermines any belief in the integrity of the 2007 federal Lyme disease guideline (referred to below).
The two-Tier testing decision tree describes the steps required to properly test for Lyme disease. One yet more serious issue is that the weak Lyme “guidelines” that follow the Infectious Disease Society America (IDSA)’s restricted approach are being used by the provinces’ physicians’ governing bodies, the Colleges, as a basis to investigate and, at times, discipline doctors known to be openly treating Lyme disease patients. Some physicians base their approach to treating Lyme disease using other practice guidelines and training available through the International Lyme and Associated Diseases Society (ILADS). One-hundred percent of all Ontario doctors who were openly clinically diagnosing and treating Lyme disease outside of the IDSA guidelines have been subjected to practice scrutiny from the governing colleges. Most have now discontinued treating Lyme patients to end what they see as “harassment.” Such harassment has left a “chill” in the medical community such that very many doctors want nothing to do with diagnosing and treating Lyme disease. Such actions by the colleges have achieved that result, whether intended or not. But, that leaves patients to fend for themselves and has forced many to seek help outside Canada. We need, as several of the U.S. states recently enacted, new “protection” legislation to allow physicians to treat Lyme disease patients based on known clinical best practices and to allow that to occur without any fear of reprisals -- which can and will fulfill what Health Canada now recommends and has proposed in the “Adverse Events” newsletter.

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