title: Accuracy of LightCycler(®) SeptiFast for the detection and identification of pathogens in the blood of patients with suspected sepsis: a systematic review and meta-analysis.
abstract: OBJECTIVE
  There is an urgent need to develop diagnostic tests to improve the detection of pathogens causing life-threatening infection (sepsis). SeptiFast is a CE-marked multi-pathogen real-time PCR system capable of detecting DNA sequences of bacteria and fungi present in blood samples within a few hours. We report here a systematic review and meta-analysis of diagnostic accuracy studies of SeptiFast in the setting of suspected sepsis.
  
  
  METHODS
  A comprehensive search strategy was developed to identify studies that compared SeptiFast with blood culture in suspected sepsis. Methodological quality was assessed using QUADAS. Heterogeneity of studies was investigated using a coupled forest plot of sensitivity and specificity and a scatter plot in receiver operator characteristic space. Bivariate model method was used to estimate summary sensitivity and specificity.
  
  
  RESULTS
  From 41 phase III diagnostic accuracy studies, summary sensitivity and specificity for SeptiFast compared with blood culture were 0.68 (95 % CI 0.63-0.73) and 0.86 (95 % CI 0.84-0.89) respectively. Study quality was judged to be variable with important deficiencies overall in design and reporting that could impact on derived diagnostic accuracy metrics.
  
  
  CONCLUSIONS
  SeptiFast appears to have higher specificity than sensitivity, but deficiencies in study quality are likely to render this body of work unreliable. Based on the evidence presented here, it remains difficult to make firm recommendations about the likely clinical utility of SeptiFast in the setting of suspected sepsis.
authors.affiliation: Infection, Injury and Inflammation Research Group, Biomedical Facility, Clinical Sciences, Manchester Academic Health Sciences Centre, Salford Royal NHS Foundation Trust, Salford, Greater Manchester, M6 8HD, UK, paul.m.dark@manchester.ac.uk.
authors.forename: Paul
authors.initials: P
authors.lastname: Dark
authors.forename: Bronagh
authors.initials: B
authors.lastname: Blackwood
authors.forename: Simon
authors.initials: S
authors.lastname: Gates
authors.forename: Danny
authors.initials: D
authors.lastname: McAuley
authors.forename: Gavin D
authors.initials: GD
authors.lastname: Perkins
authors.forename: Ronan
authors.initials: R
authors.lastname: McMullan
authors.forename: Claire
authors.initials: C
authors.lastname: Wilson
authors.forename: Daniel
authors.initials: D
authors.lastname: Graham
authors.forename: Kate
authors.initials: K
authors.lastname: Timms
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Warhurst
mesh_terms: D017848:Blood-Borne Pathogens; D006801:Humans; D060888:Real-Time Polymerase Chain Reaction / Q000295:instrumentation*; D018805:Sepsis / Q000097:blood* / Q000382:microbiology*