Health Canada : “Lyme disease test kits are class II (IV being the highest risk class) in vitro diagnostic devices. The devices are intended for the detection of antibodies to Borrelia burgdorferi in human serum, plasma or cerebrospinal fluid.1 They are used to provide serologic evidence of B. Burgdorferi exposure.1 Infection can result in dermatologic, neurologic, cardiac and musculoskeletal disorders.2 Serologic testing is the only standardized type of laboratory investigation available to support the clinical diagnosis of Lyme disease in North America.3 “
But, read their warning, …
“Many factors contribute to false negative or false-positive serologic test results for Lyme disease.1,7,9,11–14 In general, false-negative results have been attributed to (a) a slow antibody response early in the course of the disease, (b) genetic diversity of B. burgdorferi and (c) treatment with antibiotics.”
In Canada, the research of John Scott, et al, Sperling, et al, and Ogden, et al, has shown we have a wide genetic diversity of not only B. burgdorferi, but we have other ‘Lyme disease causing’ borrelia species. What this admission by Health Canada means is that the tens of thousands of Canadians tested in the past 30 years have no idea if they have Lyme disease or not. Lyme advocacy groups have been asking for this admission since the first groups were formed in 1989 (Lyme Borreliosis Society of BC) and 1990 (Lyme Disease Association of Ontario). The evidence for this is not new.