Dark, Paul, Wilson, Claire, Blackwood, Bronagh, McAuley, Daniel F., Perkins, Gavin D., McMullan, Ronan, Gates, Simon and Warhurst, Geoffrey (2012) Accuracy of LightCycler(R) SeptiFast for the detection and identification of pathogens in the blood of patients with suspected sepsis : a systematic review protocol. BMJ Open, Vol.2 (No.1). e000392-e000392. doi:10.1136/bmjopen-2011-000392

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Abstract

Background There is growing interest in the potential utility of molecular diagnostics in improving the detection of life-threatening infection (sepsis). LightCycler® SeptiFast is a multipathogen probe-based real-time PCR system targeting DNA sequences of bacteria and fungi present in blood samples within a few hours. We report here the protocol of the first systematic review of published clinical diagnostic accuracy studies of this technology when compared with blood culture in the setting of suspected sepsis.

Methods/design Data sources: the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects (DARE), the Health Technology Assessment Database (HTA), the NHS Economic Evaluation Database (NHSEED), The Cochrane Library, MEDLINE, EMBASE, ISI Web of Science, BIOSIS Previews, MEDION and the Aggressive Research Intelligence Facility Database (ARIF). Study selection: diagnostic accuracy studies that compare the real-time PCR technology with standard culture results performed on a patient's blood sample during the management of sepsis. Data extraction: three reviewers, working independently, will determine the level of evidence, methodological quality and a standard data set relating to demographics and diagnostic accuracy metrics for each study. Statistical analysis/data synthesis: heterogeneity of studies will be investigated using a coupled forest plot of sensitivity and specificity and a scatter plot in Receiver Operator Characteristic (ROC) space. Bivariate model method will be used to estimate summary sensitivity and specificity. The authors will investigate reporting biases using funnel plots based on effective sample size and regression tests of asymmetry. Subgroup analyses are planned for adults, children and infection setting (hospital vs community) if sufficient data are uncovered.

Dissemination Recommendations will be made to the Department of Health (as part of an open-access HTA report) as to whether the real-time PCR technology has sufficient clinical diagnostic accuracy potential to move forward to efficacy testing during the provision of routine clinical care.

Item Type:	Journal Article
Subjects:	R Medicine > RB Pathology
Divisions:	Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Septicemia -- Molecular diagnosis, Polymerase chain reaction -- Diagnostic use
Journal or Publication Title:	BMJ Open
Publisher:	BMJ
ISSN:	2044-6055
Official Date:	2012
Dates:	Date Event 2012 Published
Date of first compliant deposit:	20 December 2015
Volume:	Vol.2
Number:	No.1
Page Range:	e000392-e000392
DOI:	10.1136/bmjopen-2011-000392
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Funder:	National Institute for Health Research (Great Britain) (NIHR), Greater Manchester Comprehensive Local Research Network, Intensive Care Society (Great Britain) (ICS)
Grant number:	HTA 08/13/16 (NIHR)

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