Added value of multiplex Luminex Gastrointestinal Pathogen Panel (xTAG® GPP) testing in the diagnosis of infectious gastroenteritis.

Wessels, Els; Rusman, Lisette G.; Bussel, Mario J.A.W.M. van; Claas, Eric C. J.

doi:10.1111/1469-0691.12364

Cited by 112 publications

(75 citation statements)

References 18 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%

“…However, one study reported study-level results for hospital-and community-acquired infections. 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.…”

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%

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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%

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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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“…The Luminex xTAG GPP is the first commercially available assay able to simultaneously detect viruses, bacteria, and parasites on total nucleic acid isolated from a single stool specimen [18]. The present study represents the first application of xTAG GPP to human stool samples collected in Côte d'Ivoire.…”

Section: Discussionmentioning

confidence: 98%

Application of Luminex Gastrointestinal Pathogen Panel to human stool samples from Côte d’Ivoire

Cristanziano

Timmen-Wego

Lübke

et al. 2015

J Infect Dev Ctries

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Introduction: Gastrointestinal infections caused by viruses, bacteria, and parasites are endemic in most developing countries due to inadequate provision of safe water supplies, sanitation, and hygiene. To investigate the enteric pathogens infecting people living in Côte d'Ivoire, the Luminex Gastrointestinal Pathogen Panel (xTAG GPP) assay was used to analyze 34 human fecal samples. This study represents the first application of this technology to samples from a sub-Saharan African country. Methodology: Thirty-four stool samples from asymptomatic and symptomatic patients, 1-15 years of age, were analyzed by xTAG GPP. The Luminex assay represents a qualitative bead-based multiplexed molecular diagnostic test able to identify concurrently 15 enteric pathogens, including bacteria, viruses, and parasites. Results: Overall, 22 out of 34 (64.7%) fecal specimens were detected to be positive by xTAG GPP. Sixteen were from asymptomatic subjects, and 10 patients (45.4%) showed co-infections. G. duodenalis was detected in 15 patients, in both mono-and co-infections, representing the most frequent pathogen, followed by enterotoxigenic Escherichia coli (ETEC) LT/ST. Four norovirus isolates were also detected and assigned to genogroups I and II. Conclusions: Considering the burden of enteric infections in developing countries, particularly among children, and the high rate of coinfections in asymptomatic subjects, this study shows the need for diagnostic tools such as xTAG GPP to improve diagnosis and treatment of these infections in endemic areas.

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Variables Associated With Intravenous Rehydration and Hospitalization in Children With Acute Gastroenteritis

et al. 2021

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Key Points Question What clinical features are associated with intravenous rehydration and hospitalization in children with acute gastroenteritis? Findings In this secondary analysis of 2 randomized clinical trials with 1846 children, independent variables associated with intravenous rehydration included a higher clinical dehydration score, care in the US relative to Canada, greater frequency and duration of vomiting, prior intravenous rehydration, and lack of oral ondansetron. A higher clinical dehydration score, care in the US, greater frequency of vomiting, and lack of oral ondansetron were associated with hospitalization. Meaning These findings suggest that oral ondansetron may support oral rehydration therapy to reduce intravenous rehydration and the hospitalization of children with gastroenteritis.

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Added value of multiplex Luminex Gastrointestinal Pathogen Panel (xTAG® GPP) testing in the diagnosis of infectious gastroenteritis.

Cited by 112 publications

References 18 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

Application of Luminex Gastrointestinal Pathogen Panel to human stool samples from Côte d’Ivoire

Variables Associated With Intravenous Rehydration and Hospitalization in Children With Acute Gastroenteritis

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