“In 1994, at a meeting in Dearborn, Michigan, a group of laboratory scientists changed the serological definition of Lyme disease in concert with the development of a Lyme vaccine. The newblood test would make it easier to secure FDA approval for the vaccine, called LYMErix, those at the helm of product development said.”
Instead of documenting an expansion and intensification of “bands” representing antibodies to the disease on a Western blot, as before, the new, more restrictive test, called for detection of 5 of 10 bands. This was one pattern of many, according to the manufacturer, that could indicate true infection.
Among the other changes, the test would no longer consider, for purposes of diagnosis, the protein that formed the active ingredient in the vaccine –Outer Surface Protein (Osp) A. Without screening for OspA and its connected protein, OspB, a vaccinated person would test negative, clearing an easy path for FDA approval of the vaccine. However, this made it virtually impossible for many of the sickest patients to get diagnosed with Lyme, including those who would have tested positive under the previous standards.” More here: https://www.lymedisease.org/vaccine-chapter-of-cure-unknown/
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