A comparison of Luminex xTAG® Gastrointestinal Pathogen Panel (xTAG GPP) and routine tests for the detection of enteropathogens circulating in Southern China

Deng, Jiankai; Luo, Xin; Ruilian, Wang; Jiang, Lingxiao; Ding, Xiaoyi; Wu, Hao; Peng, Yongzheng; Jiang, Chang-Hong; Yu, Nan; Che, Xin

doi:10.1016/j.diagmicrobio.2015.07.024

Cited by 37 publications

(48 citation statements)

References 23 publications

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“…The xTAG GPP Luminex trial 25 did not evaluate test samples using traditional conventional methods within routine laboratory analysis, instead testing all samples at a reference laboratory; the FilmArray BioFire trial 20 only considered conventional culture results as undertaken by a routine laboratory while the presence of other pathogens was tested at BioFire with various methods and a combination of methods. Gu et al 26 added multiplex PCR testing to the in-house methods for four viruses that were not routinely tested for, creating a comparator of in-house 23 and Coste et al 22 tested all patients with conventional methods, irrespective of whether or not they were requested by the physician. Two studies tested all samples with comparator methods, but these were not equivalent to conventional methods of the PHE algorithm.…”

Section: Discussionmentioning

confidence: 99%

“…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. Studies retrospectively included samples with confirmed gastroenteritis and negative controls 30 or prospectively included samples from patients with suspected gastroenteritis.…”

Section: Discussionmentioning

confidence: 99%

“…Ten studies [20][21][22][23][24][25][26][27]29,30 reported results of association between the comparator and the GPP test in sufficient detail by pathogen to allow the construction of 2 × 2 tables by pathogen. These studies are further characterised in Table 7 and contributed data to the meta-analysis in Pathogen-level positive and negative agreement.…”

Section: Discussionmentioning

confidence: 99%

“…Studies retrospectively included samples with confirmed gastroenteritis and negative controls 30 or prospectively included samples from patients with suspected gastroenteritis. [20][21][22][23][24][25][26][27]29 Comparator and GPP tests were both undertaken at the study site(s) in seven studies, [22][23][24][25][26][27]29 whereas one study sent the samples to reference laboratories for conventional testing, 30 one study sent the samples to Luminex for GPP testing 21 and one study sent the samples to BioFire for comparator testing. 20 Verification was undertaken on all discrepant samples by four studies, 20 29 The remaining three studies, 24,26,27 which did not undertake verification, assumed either that the comparator methods are the reference standard to calculate sensitivity and specificity 24,26 or assumed that the GPP assay is correct and did not calculate sensitivity and specificity because of the lack of a resolving assay.…”

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%

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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%