Diagnostic accuracy of leptospirosis whole-cell lateral flow assays: a systematic review and meta-analysis

Maze, M.J., Sharples, K.J., Allan, K.J. , Rubach, M.P. and Crump, J.A. (2019) Diagnostic accuracy of leptospirosis whole-cell lateral flow assays: a systematic review and meta-analysis. Clinical Microbiology and Infection, 25(4), pp. 437-444. (doi:10.1016/j.cmi.2018.11.014) (PMID:30472422)

[img]
Preview
Text
174434.pdf - Published Version
Available under License Creative Commons Attribution.

1MB

Abstract

Background: Leptospirosis is under-diagnosed by clinicians in many high-incidence countries, because reference diagnostic tests are largely unavailable. Lateral flow assays (LFA) that use antigen derived from heat-treated whole cell Leptospira biflexa serovar Patoc have the potential to improve leptospirosis diagnosis in resource-limited settings. Objectives: We sought to summarize estimates of sensitivity and specificity of LFA by conducting a systematic review and meta-analysis of evaluations of the accuracy of LFA to diagnose human leptospirosis. Data sources: On 4 July 2017 we searched three medical databases. Study eligibility criteria: Articles were included if they were a study of LFA sensitivity and specificity. Participants: Patients with suspected leptospirosis. Interventions: Nil. Methods: For included articles, we assessed study quality, characteristics of participants and diagnostic testing methods. We estimated sensitivity and specificity for each study against the study-defined case definition as the reference standard, and performed a meta-analysis using a random-effects bivariate model. Results: Our search identified 225 unique reports, of which we included nine (4%) published reports containing 11 studies. We classified one (9%) study as high quality. Nine (82%) studies used reference tests with considerable risk of misclassification. Our pooled estimates of sensitivity and specificity were 79% (95% CI 70%–86%) and 92% (95% CI 85%–96%), respectively. Conclusions: As the evidence base for determining the accuracy of LFA is small and at risk of bias, pooled estimates of sensitivity and specificity should be interpreted with caution. Further studies should use either reference tests with high sensitivity and specificity or statistical techniques that account for an imperfect reference standard.

Item Type:Articles
Additional Information:This work was supported by a University of Otago Research Grant, a joint US National Institutes of Health (NIH:www.nih.gov)–National Science Foundation (NSF:www.nsf.gov) Ecology of Infectious Disease program grant (R01TW009237) and the Research Councils UK, Department for International Development (UK) and UK Biotechnology and Biological Sciences Research Council (BBSRC:www.bbsrc.ac.uk) (grant numbers BB/J010367/1, BB/L018926, BB/L017679, BB/L018845), and in part by a US National Institutes of Health International Studies on AIDS Associated Co-infections (ISAAC) award (grant number U01 AI062563) and in part by the Bill & Melinda Gates Foundation funded Typhoid Fever Surveillance in sub-Saharan Africa Program (TSAP) grant (grant number OPPGH5231). MJM received support from University of Otago scholarships: the Frances G. Cotter Scholarship and the MacGibbon Travel Fellowship. MPR received support from National Institutes of Health Research Training Grants (grant numbers R25 TW009343) funded by the Fogarty International Center and the National Institute of Mental Health. KJA received support from the Wellcome Trust (www.wellcome.ac.uk) (grant number 096400/Z/11/Z). MPR and JAC received support from a US National Institutes of Health National Institute for Allergy and Infectious grant (grant number R01 AI121378).
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Allan, Dr Kathryn
Authors: Maze, M.J., Sharples, K.J., Allan, K.J., Rubach, M.P., and Crump, J.A.
College/School:College of Medical Veterinary and Life Sciences > Institute of Biodiversity Animal Health and Comparative Medicine
Journal Name:Clinical Microbiology and Infection
Publisher:Elsevier
ISSN:1198-743X
ISSN (Online):1469-0691
Published Online:23 November 2018
Copyright Holders:Copyright © 2018 The Authors
First Published:First published in Clinical Microbiology and Infection 25:437-444
Publisher Policy:Reproduced under a Creative Commons License

University Staff: Request a correction | Enlighten Editors: Update this record

Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
568221Impact, ecology and social determinants of bacterial zoonoses in northern TanzaniaSarah CleavelandBiotechnology and Biological Sciences Research Council (BBSRC)BB/J010367/1RI BIODIVERSITY ANIMAL HEALTH & COMPMED
627871Social, economic and environmental drivers of zoonoses in Tanzania (SEEDZ)Sarah CleavelandBiotechnology and Biological Sciences Research Council (BBSRC)BB/L018926/1RI BIODIVERSITY ANIMAL HEALTH & COMPMED
628341Hazards associated with zoonotic enteric pathogens in emerging livestock meat pathways (HAZEL)Ruth ZadoksBiotechnology and Biological Sciences Research Council (BBSRC)BB/L017679/1RI BIODIVERSITY ANIMAL HEALTH & COMPMED
628321Molecular epidemology of brucellosis in northern TanzaniaDaniel HaydonBiotechnology and Biological Sciences Research Council (BBSRC)BB/L018845/1RI BIODIVERSITY ANIMAL HEALTH & COMPMED
573981Leptospirosis in Tanzania; a study of the role of rodents in an emerging public health problem.Sarah CleavelandWellcome Trust (WELLCOTR)096400/Z/11/ZRI BIODIVERSITY ANIMAL HEALTH & COMPMED