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Abstract
BackgroundLeptospirosis 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. ObjectivesWe 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 sourcesOn 4 July 2017 we searched three medical databases.Study eligibility criteriaArticles were included if they were a study of LFA sensitivity and specificity. ParticipantsPatients with suspected leptospirosis. InterventionsNil. MethodsFor 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. ResultsOur 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. ConclusionsAs 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.
Highlights
Of the studies included in our analysis, there was substantial heterogeneity in estimated sensitivity and specificity that appears to relate to study design, the choice of leptospirosis reference test, but may relate to duration of illness, the predominant infecting Leptospira serovars and variation in the production of Lateral flow assays (LFA) antigen
As such we consider our pooled estimates for the sensitivity and specificity of LFA to be unreliable and further robust evaluations are needed
We found that the estimates of sensitivity of Leptospira biflexa serovar Patoc lateral flow IgM assays varied from 55% to 93% [13,14] and estimates of specificity varied from 57% to 99% [13,16]
Summary
Inexpensive and simple pointof-care tests have been developed that detect anti-Leptospira IgM These have the potential to be deployed at both the district hospital laboratory level and the health-centre level in low-resource settings for the diagnosis of leptospirosis among febrile patients. The accuracy of LFA has been evaluated in several studies with varied estimates of both sensitivity and specificity. We conducted a systematic review and meta-analysis to summarize the sensitivity and specificity of LFA for diagnosing acute human leptospirosis in patients with suspected leptospirosis, and to identify potential reasons for variation in published estimates of diagnostic accuracy between studies. 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.
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