title: Agreement between gastrointestinal panel testing and standard microbiology methods for detecting pathogens in suspected infectious gastroenteritis: Test evaluation and meta-analysis in the absence of a reference standard.
abstract: OBJECTIVE
  Multiplex gastrointestinal pathogen panel (GPP) tests simultaneously identify bacterial, viral and parasitic pathogens from the stool samples of patients with suspected infectious gastroenteritis presenting in hospital or the community. We undertook a systematic review to compare the accuracy of GPP tests with standard microbiology techniques.
  
  
  METHODS
  Searches in Medline, Embase, Web of Science and the Cochrane library were undertaken from inception to January 2016. Eligible studies compared GPP tests with standard microbiology techniques in patients with suspected gastroenteritis. Quality assessment of included studies used tailored QUADAS-2. In the absence of a reference standard we analysed test performance taking GPP tests and standard microbiology techniques in turn as the benchmark test, using random effects meta-analysis of proportions.
  
  
  RESULTS
  No study provided an adequate reference standard with which to compare the test accuracy of GPP and conventional tests. Ten studies informed a meta-analysis of positive and negative agreement. Positive agreement across all pathogens was 0.93 (95% CI 0.90 to 0.96) when conventional methods were the benchmark and 0.68 (95% CI: 0.58 to 0.77) when GPP provided the benchmark. Negative agreement was high in both instances due to the high proportion of negative cases. GPP testing produced a greater number of pathogen-positive findings than conventional testing. It is unclear whether these additional 'positives' are clinically important.
  
  
  CONCLUSIONS
  GPP testing has the potential to simplify testing and accelerate reporting when compared to conventional microbiology methods. However the impact of GPP testing upon the management, treatment and outcome of patients is poorly understood and further studies are needed to evaluate the health economic impact of GPP testing compared with standard methods. The review protocol is registered with PROSPERO as CRD42016033320.
authors.affiliation: Warwick Medical School, University of Warwick, Coventry, United Kingdom.
authors.forename: Karoline
authors.identifier: http://orcid.org/0000-0002-9963-2918
authors.initials: K
authors.lastname: Freeman
authors.affiliation: Warwick Medical School, University of Warwick, Coventry, United Kingdom.
authors.forename: Alexander
authors.initials: A
authors.lastname: Tsertsvadze
authors.affiliation: Warwick Medical School, University of Warwick, Coventry, United Kingdom.
authors.forename: Sian
authors.initials: S
authors.lastname: Taylor-Phillips
authors.affiliation: Warwick Medical School, University of Warwick, Coventry, United Kingdom.|NIHR Health Protection Research Unit in Gastrointestinal Infections, Oxford, United Kingdom.
authors.forename: Noel
authors.initials: N
authors.lastname: McCarthy
authors.affiliation: Warwick Medical School, University of Warwick, Coventry, United Kingdom.
authors.forename: Hema
authors.initials: H
authors.lastname: Mistry
authors.affiliation: NIHR Health Protection Research Unit in Gastrointestinal Infections, London, United Kingdom.
authors.forename: Rohini
authors.initials: R
authors.lastname: Manuel
authors.affiliation: Warwick Medical School, University of Warwick, Coventry, United Kingdom.
authors.forename: James
authors.initials: J
authors.lastname: Mason
mesh_terms: D000328:Adult; D002648:Child; D005243:Feces / Q000382:microbiology / Q000469:parasitology / Q000821:virology; D005759:Gastroenteritis / Q000382:microbiology* / Q000469:parasitology / Q000821:virology; D006801:Humans; D012015:Reference Standards