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

https://doi.org/10.1016/j.cmi.2018.11.014Get rights and content
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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 criteriaArticles 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.

Keywords

Leptospira
Leptospirosis
Point-of-care systems
Sensitivity
Specificity
Zoonoses

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Presented in part at the 67th American Society of Tropical Medicine and Hygiene annual meeting, New Orleans, LA, 28 October to 1 November 2018, poster 497.