The Performance of Nine Commercial Serological Screening Assays for the Diagnosis of Lyme Borreliosis: a Multicenter Modified Two-Gate Design Study

B. J. A. Hoeve-Bakker, Mark Jonker, Afke H. Brandenburg, P. Martijn den Reijer, Foekje F. Stelma, Alje P. van Dam, Tamara van Gorkom, Karen Kerkhof, Steven F. T. Thijsen, Kristin Kremer

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4 Citations (Scopus)

Abstract

In this retrospective study, the performance of nine serological screening assays for Lyme borreliosis (LB) diagnostics was evaluated using a study population of LB cases and controls. Sera derived from 74 well-defined LB cases and 122 controls were included. The LB cases were diagnosed with erythema migrans (EM; n = 11), Lyme neuroborreliosis (LNB; n = 35), Lyme arthritis (LA; n = 20), or acrodermatitis chronica atrophicans (ACA; n = 8). Controls comprised 74 age- and gendermatched healthy individuals and 48 patients with other diseases with anticipated high rates of cross-reactivity. The assays under evaluation were selected based on a literature review and expected continued availability with CE marking under the new in vitro diagnostic regulation (European Union) 2017/746. The overall sensitivity (IgG and IgM results combined) among LB cases ranged between 54.5% (6 of 11) and 90.9% (10 of 11) for EM patients and between 97.1% (34 of 35) and 100% for patients with LNB, LA, and ACA. The positivity rate ranged between 8.1% (6 of 74) and 29.7% (22 of 74) among the healthy controls and between 22.9% (11 of 48) and 64.6% (31 of 48) among the cross-reactivity controls. The IgM results were more heterogeneous than the IgG and IgM/IgG results and did not contribute to the overall sensitivity but substantially increased the positivity rates among the controls. In conclusion, all evaluated Borrelia serological screening assays performed comparably with respect to early- and late-disseminated LB. The addition of an IgM assay to the screening of Borrelia-specific IgG antibodies had no added value for the diagnosis of Lyme borreliosis.

Original languageEnglish
Pages (from-to)e0051022
JournalMicrobiology spectrum
Volume10
Issue number2
DOIs
Publication statusPublished - 27 Apr 2022

Keywords

  • Borrelia
  • CLIA
  • ELISA
  • IgG
  • IgM
  • Lyme borreliosis
  • Lyme disease
  • evaluation
  • performance
  • serology

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