Abstract
The objective was to examine the prevalence of Borrelia antibodies among symptomatic individuals with recent and past Lyme disease in endemic communities using standard assays and novel assays employing next-generation antigenic substrates. Single- and two-tiered algorithms included different anti-Borrelia ELISAs and immunoblots. Antibody prevalence was examined in sera from 32 individuals with recent erythema migrans (EM), 335 individuals with persistent symptoms following treatment for Lyme disease (PTLS), and 41 community controls without a history of Lyme disease. Among convalescent EM cases, sensitivity was highest using the C6 ELISA (93.8%) compared to other single assays; specificity was 92.7% for the C6 ELISA vs. 85.4–97.6% for other assays. The two-tiered ELISA-EUROLINE IgG immunoblot combinations enhanced case detection substantially compared to the respective ELISA-IgG Western blot combinations (75.0% vs. 34.4%) despite similar specificity (95.1% vs. 97.6%, respectively). For PTLS cohorts, two-tier ELISA-IgG-blot positivity ranged from 10.1% to 47.4%, depending upon assay combination, time from initial infection, and clinical history. For controls, the two-tier positivity rate was 0–14.6% across assays. A two-tier algorithm of two-ELISA assays yielded a high positivity rate of 87.5% among convalescent EM cases with specificity of 92.7%. For convalescent EM, combinations of the C6 ELISA with a second-tier ELISA or line blot may provide useful alternatives to WB-based testing algorithms.
Highlights
Lyme disease, a multisystem disorder caused by tick-transmitted spirochetes of the Borrelia burgdorferi sensu lato complex, is widely distributed in the northern hemisphere with an estimated 329,000 cases per year in the United States [1] and an estimated 232,125 cases per year in Europe [2]
This study demonstrates that serologic tests that incorporate recombinant antigens (e.g., VlsE) or synthetic peptides (e.g., C6) had a high detection rate of Borrelia antibodies in the early convalescent phase after erythema migrans (EM) (93.8%) with a specificity of 92.7%
Lyme-endemic areas often prefer assays that have the highest sensitivity so as to reduce the risk of missing a true case of Lyme disease; while this may not be optimal for epidemiologic surveillance, in which specificity is of primary importance, it may be best for clinical decision making in Lyme-endemic areas, where the greater harm might be seen as not treating someone who is truly infected
Summary
A multisystem disorder caused by tick-transmitted spirochetes of the Borrelia burgdorferi sensu lato complex, is widely distributed in the northern hemisphere with an estimated 329,000 cases per year in the United States [1] and an estimated 232,125 cases per year in Europe [2]. In a subgroup of patients, symptoms recur or persist for months or years after. These patients are referred to as having post-treatment Lyme disease syndrome (PTLDS). If the emergence of fatigue, pain, or cognitive problems occurred within six months of the original infection [3]. For those individuals for whom the precise onset of infection cannot be determined or whose chronic symptoms may have started more than six months after the initial infection, there is no currently agreed upon syndromal terminology. For the purpose of this paper, we will refer to these individuals as having “post-treatment Lyme symptoms” (PTLS) for distinction from those with the more precise designation PTLDS
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