2022
DOI: 10.1128/spectrum.00510-22
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The Performance of Nine Commercial Serological Screening Assays for the Diagnosis of Lyme Borreliosis: a Multicenter Modified Two-Gate Design Study

Abstract: Serology plays an important role in the diagnosis of Lyme borreliosis. Guidelines prescribe a two-tier testing algorithm in which a highly sensitive screening assay is used for screening and reactive sera are retested with an immunoblot to reduce false positivity rates.

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Cited by 6 publications
(4 citation statements)
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“…Additionally, although IgG is generally the isotype tested for in seroprevalence studies [6,24], immunoblot confirmation using IgM was also included in this study. The inevitably observed IgM-only seropositive results may be explained by (i) early infection at the time of sampling, (ii) abrogated isotype-switching due to spirochetal clearance from effective antibiotic treatment [26,27], (iii) persistent IgM response [28] or (iv) false-positive reaction due to cross-reacting IgM antibodies [23,29].…”
Section: Discussionmentioning
confidence: 99%
“…Additionally, although IgG is generally the isotype tested for in seroprevalence studies [6,24], immunoblot confirmation using IgM was also included in this study. The inevitably observed IgM-only seropositive results may be explained by (i) early infection at the time of sampling, (ii) abrogated isotype-switching due to spirochetal clearance from effective antibiotic treatment [26,27], (iii) persistent IgM response [28] or (iv) false-positive reaction due to cross-reacting IgM antibodies [23,29].…”
Section: Discussionmentioning
confidence: 99%
“…The results of CLIA were expressed using the antibody index calculated as the ratio between the sample Relative Light Unit (RLU) and the calibrator RLU. The VirClia ® IgG assay showed sensitivity ranging from 79% to 95.9% and specificity from 93.8% to 97.9% on C. burnetii , B. henselae and Borrelia spp., agreeing when compared with both ELISA and IFA testing [ 28 30 ]. Results were interpreted according to the manufacturer’s instructions.…”
Section: Methodsmentioning
confidence: 84%
“…The specific IgM class antibody is present in the blood of the infected individual from 3 weeks to 6 months after a tick bite, while the IgG class antibody appears after 6 weeks and can appear in the blood of the infected individual after recovery [ 4 ]. In a retrospective analysis that included 74 cases of patients with Lyme borreliosis and 122 controls, Hoeve-Bakker et al showed that there was little diagnostic value of IgM class antibody determination in screening for Lyme disease [ 12 ]. Therefore, positive IgM results for the diagnosis of Lyme disease should be approached with caution [ 12 ].…”
Section: Backgrondmentioning
confidence: 99%
“…In a retrospective analysis that included 74 cases of patients with Lyme borreliosis and 122 controls, Hoeve-Bakker et al showed that there was little diagnostic value of IgM class antibody determination in screening for Lyme disease [ 12 ]. Therefore, positive IgM results for the diagnosis of Lyme disease should be approached with caution [ 12 ]. The multiplicity of B. burgdorferi that resides in the middle intestine of the tick and the multitude of symptoms caused by it in patients, in addition to the lack of uniform diagnostic tests, lead to a delay in the initiation of treatment that can transition to chronic Lyme borreliosis, which in turn leads to a multi-organ and multi-system disease [ 13 ].…”
Section: Backgrondmentioning
confidence: 99%