Intensive Care Medicine

, Volume 41, Issue 1, pp 21–33 | Cite as

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

  • Paul Dark
  • Bronagh Blackwood
  • Simon Gates
  • Danny McAuley
  • Gavin D. Perkins
  • Ronan McMullan
  • Claire Wilson
  • Daniel Graham
  • Kate Timms
  • Geoffrey Warhurst
Systematic Review



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.


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.


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.


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.


Sepsis Bloodstream infection Real-time PCR Diagnostic accuracy 



We thank Mrs Helen McEvoy, formerly at the University of Manchester, School of Medicine Library, for her assistance with search strategy design and Mrs Valerie Haigh, Salford Royal NHS Foundation Trust Library and Information Resource Centre, for her advice on the use of filters in diagnostic search strategies. PD and GW were part-funded by the UK Health Technology Assessment (HTA) programme of the National Institute of Health Research grant number NIHR HTA 08/13/16. CW and DG were funded by NIHR Greater Manchester Comprehensive Local Research Network in support of this programme of work. DFM and GDP receive funding from The Intensive Care Foundation (UK) in support of their roles as National Research Directors. None of these funding organisations or any commercial organisation have contributed to the study design; collection, management, analysis and interpretation of data; writing of the report or the decision to submit the report for publication. Only the named authors have ultimate authority over each of these activities.

Conflicts of interest


Study registration

PROSPERO—NIHR Prospective Register of Systematic Reviews (CRD42011001289).


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Copyright information

© Springer-Verlag Berlin Heidelberg and ESICM 2014

Authors and Affiliations

  • Paul Dark
    • 1
    • 2
    • 3
  • Bronagh Blackwood
    • 4
  • Simon Gates
    • 5
  • Danny McAuley
    • 4
  • Gavin D. Perkins
    • 5
    • 6
  • Ronan McMullan
    • 7
  • Claire Wilson
    • 1
    • 3
  • Daniel Graham
    • 1
    • 3
  • Kate Timms
    • 1
    • 3
  • Geoffrey Warhurst
    • 1
    • 3
    • 8
  1. 1.Infection, Injury and Inflammation Research Group, Biomedical Facility, Clinical Sciences, Manchester Academic Health Sciences CentreSalford Royal NHS Foundation TrustSalfordUK
  2. 2.Intensive Care UnitSalford Royal NHS FoundationSalfordUK
  3. 3.Faculty of Medical and Human Sciences, Institute of Inflammation and RepairUniversity of ManchesterManchesterUK
  4. 4.Centre for Infection and ImmunityQueen’s UniversityBelfastUK
  5. 5.Clinical Trials Unit, Warwick Medical SchoolUniversity of WarwickCoventryUK
  6. 6.Birmingham Heartlands HospitalHeart of England NHS Foundation TrustBirminghamUK
  7. 7.Department of Medical MicrobiologyRoyal Victoria HospitalBelfastUK
  8. 8.Biomedical Research Institute, School of Environment & Life SciencesUniversity of Salford, Manchester Academic Health Sciences CentreSalfordUK

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