Abstract
Lyme disease (LD), caused by infection with Borrelia burgdorferi, is the most common tick-borne infection in many regions of Eurasia. Antibody detection is the most frequently used laboratory test, favoring a two-step serodiagnostic algorithm; immunoenzymatic detection of antibodies to C6 has been shown to perform similarly to a standard two-step workflow. The aim of this study was the performance evaluation of the C6 Lyme ELISA kit compared to a standard two-step algorithm in three laboratories located in the northeastern region of Italy which cater to areas with different LD epidemiology. A total of 804 samples were tested, of which 695 gave concordant results between C6 testing and routine workflow (564 negative, 131 positive). Wherever available, clinical presentation and additional laboratory tests were analyzed to solve discrepancies. The C6 based method showed a good concordance with the standard two-step algorithm (Cohen’s κ = 0.619), however, the distribution of discrepancies seems to point towards a slightly lower specificity of C6 testing, which is supported by literature and could impact on patient management. The C6 ELISA, therefore, is not an ideal stand-alone test; however, if integrated into a two-step algorithm, it might play a part in achieving a sensitive, specific laboratory diagnosis of LD.
Highlights
IntroductionLyme disease (LD) is the most common tick-borne infection in many regions of Eurasia [1]
Lyme disease (LD) is the most common tick-borne infection in many regions of Eurasia [1]. It is caused by the infection with Borrelia burgdorferi sensu lato spirochetes, which are transmitted by the bite of ixodid ticks where Ixodes ricinus is the main vector found in Europe [2]
Each of the three laboratories involved in the study collected at least 200 samples routinely tested for anti-B. burgdorferi IgM and IgG antibodies, of which at least 50 were from patients presenting potential interfering factors that could potentially give false-positive results due to cross-reactions (Treponema pallidum or Epstein-Barr virus (EBV) infection, positivity to anti-nuclear antibodies indicating an autoimmune disease, ongoing pregnancy)
Summary
Lyme disease (LD) is the most common tick-borne infection in many regions of Eurasia [1]. It is caused by the infection with Borrelia burgdorferi sensu lato spirochetes, which are transmitted by the bite of ixodid ticks where Ixodes ricinus is the main vector found in Europe [2]. The detection of B. burgdorferi DNA in samples such as skin biopsy or blood specimens would be an ideal choice in terms of specificity, the sensitivity of molecular testing is not sufficient for a negative result to rule out infection, especially in the cases of suspected neuroborreliosis [3,4]
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