The value of a multiplexed gastrointestinal pathogen panel in 2 distinct patient populations

Petterson, Jonas; York, Vincent; Ward, Pamela; Green, Nicole; She, Rosemary C.

doi:10.1016/j.diagmicrobio.2015.12.020

Cited by 3 publications

(7 citation statements)

References 17 publications

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“…11,12,[20][21][22][23]25,[29][30][31][32][33][34]38,39 However, only four studies reported outcomes of verification by pathogen. 20,23,25,30 Study design Table 7 characterises the design heterogeneity among the studies reported, which should be noted when considering the pooled study outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…Seven studies 19,22,26,27,29,35,39 reported the setting sufficiently to allow judgement on the origin of the infection (hospital vs. community). The majority of studies 11,12,20,21,[23][24][25]28,[30][31][32][33][34][36][37][38] reported recruitment of hospitalised patients, for which a mixed population should be assumed (in terms of origin of infection) as it is unclear at what point in time during hospitalisation each infection occurred. Only one study was identified as a community study, set in Côte d'Ivoire.…”

Section: Participantsmentioning

confidence: 99%

“…27 Country of study Eleven studies 11,22,[27][28][29][30]32,35,[37][38][39] included participants from European countries, including three studies from the UK. 27,30,32 One study was multinational, covering North America and Europe, 21 eight studies were from North America, 12,20,25,26,31,33,34,36 two were from Asia 23,24 and one was from Africa. 19 Therefore, the applicability of the study population in terms of prevalence of pathogens is questionable in 3 out of the 23 studies (see Quality considerations of included studies).…”

Section: Participantsmentioning

confidence: 99%

“…Only two studies 19,32 were rated as having high concern for the applicability with respect to the index tests (because of deviations from the manufacturer's instructions: timing, storage or extraction). The applicability of a comparator was of low concern for six studies (26.1%) 12,21,26,27,29,36 and of high concern for 16 studies (69.6%), 11,19,20,[22][23][24][25]28,[30][31][32][33][34][37][38][39] in which the comparator methods were not consistent with those specified for the PHE algorithm. The applicability concern for a reference standard (i.e.…”

Section: 30mentioning

confidence: 99%

“…verification tests) was high for all 15 studies using such tests. 11,12,[20][21][22][23]25,[29][30][31][32][33][34]38,39 The remaining eight studies did not use the verification tests (not applicable). 19,24,[26][27][28][35][36][37] Agreement between gastrointestinal pathogen panel tests and conventional methods…”

Section: 30mentioning

confidence: 99%

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Multiplex tests to identify gastrointestinal bacteria, viruses and parasites in people with suspected infectious gastroenteritis: a systematic review and economic analysis

Freeman

Mistry

Tsertsvadze

et al. 2017

Health Technol Assess

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Background Gastroenteritis is a common, transient disorder usually caused by infection and characterised by the acute onset of diarrhoea. Multiplex gastrointestinal pathogen panel (GPP) tests simultaneously identify common bacterial, viral and parasitic pathogens using molecular testing. By providing test results more rapidly than conventional testing methods, GPP tests might positively influence the treatment and management of patients presenting in hospital or in the community. Objective To systematically review the evidence for GPP tests [xTAG® (Luminex, Toronto, ON, Canada), FilmArray (BioFire Diagnostics, Salt Lake City, UT, USA) and Faecal Pathogens B (AusDiagnostics, Beaconsfield, NSW, Australia)] and to develop a de novo economic model to compare the cost-effectiveness of GPP tests with conventional testing in England and Wales. Data sources Multiple electronic databases including MEDLINE, EMBASE, Web of Science and the Cochrane Database were searched from inception to January 2016 (with supplementary searches of other online resources). Review methods Eligible studies included patients with acute diarrhoea; comparing GPP tests with standard microbiology techniques; and patient, management, test accuracy or cost-effectiveness outcomes. Quality assessment of eligible studies used tailored Quality Assessment of Diagnostic Accuracy Studies-2, Consolidated Health Economic Evaluation Reporting Standards and Philips checklists. The meta-analysis included positive and negative agreement estimated for each pathogen. A de novo decision tree model compared patients managed with GPP testing or comparable coverage with patients managed using conventional tests, within the Public Health England pathway. Economic models included hospital and community management of patients with suspected gastroenteritis. The model estimated costs (in 2014/15 prices) and quality-adjusted life-year losses from a NHS and Personal Social Services perspective. Results Twenty-three studies informed the review of clinical evidence (17 xTAG, four FilmArray, two xTAG and FilmArray, 0 Faecal Pathogens B). No study provided an adequate reference standard with which to compare the test accuracy of GPP with conventional tests. A meta-analysis (of 10 studies) found considerable heterogeneity; however, GPP testing produces a greater number of pathogen-positive findings than conventional testing. It is unclear whether or not these additional ‘positives’ are clinically important. The review identified no robust evidence to inform consequent clinical management of patients. There is considerable uncertainty about the cost-effectiveness of GPP panels used to test for suspected infectious gastroenteritis in hospital and community settings. Uncertainties in the model include length of stay, assumptions about false-positive findings and the costs of tests. Although there is potential for cost-effectiveness in both settings, key modelling assumptions need to be verified and model findings remain tentative. Limitations No test–treat trials were retrieved. The economic model reflects one pattern of care, which will vary across the NHS. Conclusions The systematic review and cost-effectiveness model identify uncertainties about the adoption of GPP tests within the NHS. GPP testing will generally correctly identify pathogens identified by conventional testing; however, these tests also generate considerable additional positive results of uncertain clinical importance. Future work An independent reference standard may not exist to evaluate alternative approaches to testing. A test–treat trial might ascertain whether or not additional GPP ‘positives’ are clinically important or result in overdiagnoses, whether or not earlier diagnosis leads to earlier discharge in patients and what the health consequences of earlier intervention are. Future work might also consider the public health impact of different testing treatments, as test results form the basis for public health surveillance. Study registration This study is registered as PROSPERO CRD2016033320. Funding The National Institute for Health Research Health Technology Assessment programme.

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Section: Discussionmentioning

confidence: 99%

Section: Participantsmentioning

confidence: 99%

Section: Participantsmentioning

confidence: 99%

Section: 30mentioning

confidence: 99%

Section: 30mentioning

confidence: 99%

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Multiplex tests to identify gastrointestinal bacteria, viruses and parasites in people with suspected infectious gastroenteritis: a systematic review and economic analysis

Freeman

Mistry

Tsertsvadze

et al. 2017

Health Technol Assess

View full text Add to dashboard Cite

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New Technologies for Detection of Enteric Parasites

Ryan

Paparini

Oskam

2017

Trends in Parasitology

104

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Diagnostic Test Accuracy of Commercial Tests for Detection of Shiga Toxin–Producing Escherichia coli: A Systematic Review and Meta-Analysis

et al. 2020

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Background Rapid detection of Shiga toxin–producing Escherichia coli (STEC) enables appropriate monitoring and treatment. We synthesized available evidence to compare the performance of enzyme immunoassay (EIA) and PCR tests for the detection of STEC. Methods We searched published and gray literature for studies of STEC EIA and/or PCR diagnostic test accuracy relative to reference standards including at least one nucleic acid amplification test. Two reviewers independently screened studies, extracted data, and assessed quality with the second version of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Bivariate random effects models were used to meta-analyze the clinical sensitivity and specificity of commercial EIA and PCR STEC diagnostic tests, and summary receiver operator characteristic curves were constructed. We evaluated the certainty of evidence with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results We identified 43 articles reflecting 25 260 specimens. Meta-analysis of EIA and PCR accuracy included 25 and 22 articles, respectively. STEC EIA pooled sensitivity and specificity were 0.681 (95% CI, 0.571–0.773; very low certainty of evidence) and 1.00 (95% CI, 0.998–1.00; moderate certainty of evidence), respectively. STEC PCR pooled sensitivity and specificity were 1.00 (95% CI, 0.904–1.00; low certainty of evidence) and 0.999 (95% CI, 0.997–0.999; low certainty of evidence), respectively. Certainty of evidence was downgraded because of high risk of bias. Conclusions PCR tests to identify the presence of STEC are more sensitive than EIA tests, with no meaningful loss of specificity. However, given the low certainty of evidence, our results may overestimate the difference in performance.

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The value of a multiplexed gastrointestinal pathogen panel in 2 distinct patient populations

Cited by 3 publications

References 17 publications

Multiplex tests to identify gastrointestinal bacteria, viruses and parasites in people with suspected infectious gastroenteritis: a systematic review and economic analysis

Multiplex tests to identify gastrointestinal bacteria, viruses and parasites in people with suspected infectious gastroenteritis: a systematic review and economic analysis

New Technologies for Detection of Enteric Parasites

Diagnostic Test Accuracy of Commercial Tests for Detection of Shiga Toxin–Producing Escherichia coli: A Systematic Review and Meta-Analysis

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