Author:

Keywords:

Science & Technology, Life Sciences & Biomedicine, Infectious Diseases, Microbiology, Pharmacology & Pharmacy, 1108 Medical Microbiology, 1115 Pharmacology and Pharmaceutical Sciences, 3107 Microbiology, 3207 Medical microbiology

Abstract:

Objectives: Lyme borreliosis (LB) caused by Borrelia burgorferi sensulato is the most common vector-born disease in North America and Europe. According to guidelines serological diagnosis of LB should follow a two-step procedure: a screeningtest and if reactive followed by an immunoblot. A large variety of commercial assay is available for the serological diagnosis of LB. We evaluated the performance of five commercial screening assays for the detection of both IgM and IgG antibodies to B. burgdorferi as well as of two commercial immunoblots used as confirmation of serological LB diagnosis in clinical cases of LB. Methods: The assays tested were Quick ELISA C6 (Immunetics), VIDAS Lyme (BioM´erieux), Enzygnost Borreliosis IgM and IgG (Dade Behring), Enzygnost Lyme link VlsE/IgG (Dade Behring) and Euroimmun Anti-Borrelia IgM and IgG (Euroimmun). The testpanel (n = 73) included sera of patients with a documented clinical history of LB and was divided into 4 groups according to the symptoms: erythema migrans (EM), facialis parese (FP), neuroborreliosis (NB) and other symptoms (OS). All LB patients’ sera were also tested by two different immunoblot (WB) assays: the Mikrogen recomblot Borrelia (Mikrogen) and the Euroline-Western Blot (Euroimmun). Additionally, specificities of the screening assays were evaluated by using 50 possible cross-reactive sera. Results: The sensitivities obtained showed that all screening assays (total antibodies or combination of IgM and IgG assay), provided comparable results for all 4 clinical groups ranging from 94.5% (VIDAS Lyme) to 98.6% (Quick ELISA C6). The lowest sensitivities were observed for the group EM. The specificities ranged from 66% (VIDAS Lyme) to 96% (Quick ELISA C6). The lack of specificity seen with the VIDAS assay was mainly caused by cross-reactivity with samples from patients with active syphilis. The Quick ELISA C6 provided both the best positive (97.3%) and negative (98.0%) predictive value. Considering the confirmatory tests, the Euroline WB IgG achieved the highest sensitivities for all groups, while the Mikrogen recomblot IgM showed a better sensitivity than the Euroline WB IgM. When combining WB IgG and WB IgM, however, both WB had similar sensitivities. Conclusion: The results obtained for all groups of clinical LB indicate that the Quick ELISA assay performs better than the other 4 screening assays. Sensitivities of Mikrogen and Euroimmun immunoblots were similar when combining both IgM and IgG results.