A serology-based, tiered approach has, to date, provided the most effective means of laboratory confirmation of clinically suspected cases of Lyme disease but lacks sensitivity in early disease and is often dependent on subjectively scored immunoblots. We recently demonstrated use of immuno-PCR (iPCR) for detection of B. burgdorferi antibodies in Lyme disease patient serum. To better understand the performance of the Lyme disease iPCR assay, the repeatability and the variability of the background of the assay across a healthy population (n=36) was analyzed. Both of these parameters were found to have coefficients of variation of less than 3%. Using eight antigen-specific iPCR assays and positive call thresholds established for each assay, iPCR IgM and/or IgG diagnosis of Lyme disease patient sera (n=12) demonstrated strong correlation with that of 2-tier testing. Furthermore, a simplified iPCR approach, using a single hybrid antigen and detection of IgG antibodies only, confirmed the 2-tier analysis diagnosis of Lyme disease patient sera (n=12). Validation of the hybrid antigen IgG iPCR assay using a blinded panel of Lyme disease and non-Lyme disease patient sera (n=92) resulted in a sensitivity of 69% (95% CI: 50%-84%) compared to 2-tier analysis at 59% (95% CI: 41%-76%) and a specificity of 98% (95% CI: 91%-100%) as compared to 2-tier analysis at 97% (95% CI: 88%-100%). A single tier hybrid antigen iPCR assay has the potential to be an improved method for detecting host generated antibodies against B. burgdorferi.
[Show abstract][Hide abstract] ABSTRACT: Lyme disease has become a global public health problem and a prototype of an emerging infection. Both treatment-refractory infection and symptoms that are related to Borrelia burgdorferi infection remain subject to controversy. Because of the absence of solid evidence on prevalence, causes, diagnostic criteria, tools and treatment options, the role of autoimmunity to residual or persisting antigens, and the role of a toxin or other bacterial-associated products that are responsible for the symptoms and signs, chronic Lyme disease (CLD) remains a relatively poorly understood chronic disease construct. The role and performance of family medicine in the detection, integrative treatment, and follow-up of CLD are not well studied either. The purpose of this paper is to describe insights into the complexity of CLD as a multidimensional chronic disease construct and its relevance to family medicine by means of a systematic literature review.
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