Evaluation of different standard and modified two-tier testing strategies for the laboratory diagnosis of lyme borreliosis in a European setting.

Autor: Hoeve-Bakker BJA; Department of Medical Microbiology and Immunology, Diakonessenhuis Hospital, Utrecht, The Netherlands. Dieneke.Hoeve@rivm.nl.; Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands. Dieneke.Hoeve@rivm.nl., Kerkhof K; Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands., Heron M; Department of Medical Microbiology and Immunology, Diakonessenhuis Hospital, Utrecht, The Netherlands., Thijsen SFT; Department of Medical Microbiology and Immunology, Diakonessenhuis Hospital, Utrecht, The Netherlands.; Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands., van Gorkom T; Department of Medical Microbiology and Immunology, Diakonessenhuis Hospital, Utrecht, The Netherlands.; Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
Jazyk: angličtina
Zdroj: European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology [Eur J Clin Microbiol Infect Dis] 2024 Dec; Vol. 43 (12), pp. 2397-2406. Date of Electronic Publication: 2024 Oct 07.
DOI: 10.1007/s10096-024-04956-y
Abstrakt: Background: Diagnosis of Lyme borreliosis (LB) relies on clinical symptoms and detection of Borrelia-specific antibodies. Guidelines recommend a two-tier testing (TTT) strategy for disseminated LB: serological screening with a sensitive enzyme immunoassay (EIA) and confirmation with a specific immunoblot. Searching for the most sensitive and specific approach, this retrospective study evaluated standard (STTT) and modified (MTTT) strategies using a well-defined study population.
Methods: Cases included patients with active Lyme neuroborreliosis (LNB; n = 29) or Lyme arthritis (LA; n = 17). Controls comprised patients treated for LNB (n = 36) or LA (n = 8), healthy individuals who were either untreated (n = 75) or treated for LB (n = 15) in the past, and patients with potentially cross-reactive diseases (n = 16). Sera were subjected to three EIAs and two immunoblots. Reactive screening results were confirmed by immunoblot (STTT) or EIA (MTTT). Solitary IgM results in the screening assay and effects of antibiotic treatment on isotype-specific seropositivity rates were also assessed.
Results: Sensitivities of STTT strategies ranged from 90%-97% for LNB and were 100% for LA. MTTT strategies were 100% sensitive. Specificities ranged from 89%-95% for STTT and from 88%-93% for MTTT strategies. Differences between STTT and MTTT strategies were not statistically significant. Solitary IgM reactivity was common among controls. Antibiotic treatment significantly reduced IgM/IgG positivity for LNB patients; for LA patients, a decline was only observed for IgM.
Conclusion: In conclusion, MTTT strategies showed a slightly higher sensitivity and similar specificity compared to STTT strategies. Since EIAs are more time- and cost-efficient, MTTT strategies seem more favorable for clinical use. IgG testing enhances specificity with minimal sensitivity loss.
Competing Interests: Declarations. Ethics approval: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study “T-cell response in Lyme” (TRIL) was approved by the regional Medical Research Ethics Committees United (MEC-U), Nieuwegein, The Netherlands and registered with the Central Committee on Research Involving Human Subjects (CCMO) of the Netherlands under number NL36407.100.11 at 09–07-2020. Consent to participate: Informed consent was obtained from all individual participants included in the TRIL study. Competing interests: The authors declare no competing interests.
(© 2024. The Author(s).)
Databáze: MEDLINE
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