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

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.

SUBMITTER: Maze MJ

PROVIDER: S-EPMC6456420 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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

Maze M J MJ Sharples K J KJ Allan K J KJ Rubach M P MP Crump J A JA

Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases 20181123 4

<h4>Background</h4>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.<h4>Objectives</h4>We sought to summarize estimates of sensitivity and specificity of LFA by conducting a systematic review and meta-analysis of ...[more]

PMID: 30472422

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Project description:Timely and accurate methods for detecting Clostridium perfringens-associated diseases (CPAD) are crucial to improve patient care. A number of studies have evaluated the accuracy of nucleic acid amplification tests (NAAT) in detecting CPAD, but decisive results about their effectiveness have not been reported. We conducted a meta-analysis to evaluate the diagnostic performance of NAAT for detecting C. perfringens in clinical diarrheal samples. Five databases including PubMed, Embase, Scopus, Web of Science, and the Cochrane library were systematically probed for studies published before 6 December 2019. From 2,632 citations, we identified five eligible studies comprising 817 samples. Three studies (n?=?695 samples) compared NAAT with a microbiological culture while the other three studies (n?=?322 samples) compared NAAT with an immunoassay. NAAT revealed higher diagnostic accuracy against immunoassay (sensitivity, 0.53 [95% confidence interval [CI], 0.35 to 0.7]; specificity, 0.97 [95% CI, 0.95 to 0.99]; positive likelihood ratio [PLR], 23.2 [95% CI, 3.49 to 153.98]; negative likelihood ratio [NLR], 0.25 [95% CI, 0 to 245.28]; diagnostic odds ratio [DOR], 74.11 [95% CI, 2.11 to 2,593.7]) than microbiological culture (sensitivity, 0.31 [95% CI, 0.22 to 0.41]; specificity, 0.95 [95% CI, 0.93 to 0.97]; PLR, 11.56 [95% CI, 3.87 to 34.6]; NLR, 0.57 [95% CI, 0.27 to 1.21]; DOR, 18.1 [95% CI, 4.83 to 67.8]). NAAT pooled specificity was consistently ?95% against that of applied reference standards. A meta-regression and subgroup analysis of sample condition, gene target, study design, and reference standards could not explain the heterogeneity (P > 0.05) in the diagnostic efficiency. The analysis has demonstrated that the diagnostic accuracy of NAAT is relatively insufficient to replace traditional reference standards as a single diagnostic test. NAAT can be applied in combination with microbiological culture because of the advantage of time to result and in scenarios where traditional tests are not feasible. Further investigations in this direction with larger sample sizes are still warranted to support our findings.

Project description:ObjectiveTo evaluate the performance of new lateral flow immunoassays (LFIAs) suitable for use in a national coronavirus disease 2019 (covid-19) seroprevalence programme (real time assessment of community transmission 2-React 2).DesignDiagnostic accuracy study.SettingLaboratory analyses were performed in the United Kingdom at Imperial College, London and university facilities in London. Research clinics for finger prick sampling were run in two affiliated NHS trusts.ParticipantsSensitivity analyses were performed on sera stored from 320 previous participants in the React 2 programme with confirmed previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Specificity analyses were performed on 1000 prepandemic serum samples. 100 new participants with confirmed previous SARS-CoV-2 infection attended study clinics for finger prick testing.InterventionsLaboratory sensitivity and specificity analyses were performed for seven LFIAs on a minimum of 200 serum samples from participants with confirmed SARS-CoV-2 infection and 500 prepandemic serum samples, respectively. Three LFIAs were found to have a laboratory sensitivity superior to the finger prick sensitivity of the LFIA currently used in React 2 seroprevalence studies (84%). These LFIAs were then further evaluated through finger prick testing on participants with confirmed previous SARS-CoV-2 infection: two LFIAs (Surescreen, Panbio) were evaluated in clinics in June-July 2020 and the third LFIA (AbC-19) in September 2020. A spike protein enzyme linked immunoassay and hybrid double antigen binding assay were used as laboratory reference standards.Main outcome measuresThe accuracy of LFIAs in detecting immunoglobulin G (IgG) antibodies to SARS-CoV-2 compared with two reference standards.ResultsThe sensitivity and specificity of seven new LFIAs that were analysed using sera varied from 69% to 100%, and from 98.6% to 100%, respectively (compared with the two reference standards). Sensitivity on finger prick testing was 77% (95% confidence interval 61.4% to 88.2%) for Panbio, 86% (72.7% to 94.8%) for Surescreen, and 69% (53.8% to 81.3%) for AbC-19 compared with the reference standards. Sensitivity for sera from matched clinical samples performed on AbC-19 was significantly higher with serum than finger prick at 92% (80.0% to 97.7%, P=0.01). Antibody titres varied considerably among cohorts. The numbers of positive samples identified by finger prick in the lowest antibody titre quarter varied among LFIAs.ConclusionsOne new LFIA was identified with clinical performance suitable for potential inclusion in seroprevalence studies. However, none of the LFIAs tested had clearly superior performance to the LFIA currently used in React 2 seroprevalence surveys, and none showed sufficient sensitivity and specificity to be considered for routine clinical use.

Project description:ObjectiveTo determine the diagnostic accuracy of serological tests for coronavirus disease-2019 (covid-19).DesignSystematic review and meta-analysis.Data sourcesMedline, bioRxiv, and medRxiv from 1 January to 30 April 2020, using subject headings or subheadings combined with text words for the concepts of covid-19 and serological tests for covid-19.Eligibility criteria and data analysisEligible studies measured sensitivity or specificity, or both of a covid-19 serological test compared with a reference standard of viral culture or reverse transcriptase polymerase chain reaction. Studies were excluded with fewer than five participants or samples. Risk of bias was assessed using quality assessment of diagnostic accuracy studies 2 (QUADAS-2). Pooled sensitivity and specificity were estimated using random effects bivariate meta-analyses.Main outcome measuresThe primary outcome was overall sensitivity and specificity, stratified by method of serological testing (enzyme linked immunosorbent assays (ELISAs), lateral flow immunoassays (LFIAs), or chemiluminescent immunoassays (CLIAs)) and immunoglobulin class (IgG, IgM, or both). Secondary outcomes were stratum specific sensitivity and specificity within subgroups defined by study or participant characteristics, including time since symptom onset.Results5016 references were identified and 40 studies included. 49 risk of bias assessments were carried out (one for each population and method evaluated). High risk of patient selection bias was found in 98% (48/49) of assessments and high or unclear risk of bias from performance or interpretation of the serological test in 73% (36/49). Only 10% (4/40) of studies included outpatients. Only two studies evaluated tests at the point of care. For each method of testing, pooled sensitivity and specificity were not associated with the immunoglobulin class measured. The pooled sensitivity of ELISAs measuring IgG or IgM was 84.3% (95% confidence interval 75.6% to 90.9%), of LFIAs was 66.0% (49.3% to 79.3%), and of CLIAs was 97.8% (46.2% to 100%). In all analyses, pooled sensitivity was lower for LFIAs, the potential point-of-care method. Pooled specificities ranged from 96.6% to 99.7%. Of the samples used for estimating specificity, 83% (10 465/12 547) were from populations tested before the epidemic or not suspected of having covid-19. Among LFIAs, pooled sensitivity of commercial kits (65.0%, 49.0% to 78.2%) was lower than that of non-commercial tests (88.2%, 83.6% to 91.3%). Heterogeneity was seen in all analyses. Sensitivity was higher at least three weeks after symptom onset (ranging from 69.9% to 98.9%) compared with within the first week (from 13.4% to 50.3%).ConclusionHigher quality clinical studies assessing the diagnostic accuracy of serological tests for covid-19 are urgently needed. Currently, available evidence does not support the continued use of existing point-of-care serological tests.Study registrationPROSPERO CRD42020179452.

Dataset Information

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

Publications

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

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