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

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

71 Citations (Scopus)
416 Downloads (Pure)

Abstract

Purpose: 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.

Original languageEnglish
Pages (from-to)21-33
Number of pages13
JournalIntensive Care Medicine
Volume41
Issue number1
Early online date22 Nov 2014
DOIs
Publication statusPublished - Jan 2015

Bibliographical note

The contribution of this manuscript to the body of evidence on the topic is underscored by its 70 citations - representing, on average more than 11 per year since publication.

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