The clinical diagnostic accuracy of rapid detection of healthcare-associated bloodstream infection in intensive care using multipathogen real-time PCR technology

被引：22

作者：

Dark, Paul ^{[1
,2
,3
]}

Dunn, Graham ^{[4
]}

Chadwick, Paul ^{[1
,5
]}

Young, Duncan ^{[6
]}

Bentley, Andrew ^{[3
,7
]}

Carlson, Gordon ^{[1
]}

Warhurst, Geoffrey ^{[1
]}

机构：

[1] Salford Royal NHS Fdn Trust, Manchester Acad Hlth Sci Ctr, Biomed Facil, Infect Injury & Inflammat Res Grp, Salford, Lancs, England

[2] Salford Royal NHS Fdn Trust, Manchester Acad Hlth Sci Ctr, Intens Care Unit, Salford, Lancs, England

[3] Univ Manchester, Fac Med & Human Sci, Sch Translat Med, Resp Med Res Grp, Manchester, Lancs, England

[4] Univ Manchester, Fac Med & Human Sci, Hlth Methodol Res Grp, Manchester, Lancs, England

[5] Salford Royal NHS Fdn Trust, Manchester Acad Hlth Sci Ctr, Dept Microbiol, Salford, Lancs, England

[6] Univ Oxford, John Radcliffe Hosp, Nuffield Dept Anaesthet, Oxford OX3 9DU, England

[7] Univ S Manchester Hosp, Manchester Acad Hlth Sci Ctr, Adult Intens Care Unit, Manchester M20 8LR, Lancs, England

来源：

BMJ OPEN | 2011年 / 1卷 / 01期

关键词：

SEPSIS; PREVALENCE; BIOMARKERS; PATHOGENS;

D O I：

10.1136/bmjopen-2011-000181

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: There is growing interest in the potential utility of real-time PCR in diagnosing bloodstream infection by detecting pathogen DNA in blood samples within a few hours. SeptiFast is a multipathogen probe-based real-time PCR system targeting ribosomal DNA sequences of bacteria and fungi. It detects and identifies the commonest pathogens causing bloodstream infection and has European regulatory approval. The SeptiFast pathogen panel is suited to identifying healthcare-associated bloodstream infection acquired during complex healthcare, and the authors report here the protocol for the first detailed health-technology assessment of multiplex real-time PCR in this setting. Methods/design: A Phase III multicentre double-blinded diagnostic study will determine the clinical validity of SeptiFast for the rapid detection of healthcare-associated bloodstream infection, against the current service standard of microbiological culture, in an adequately sized population of critically ill adult patients. Results from SeptiFast and standard microbiological culture procedures in each patient will be compared at study conclusion and the metrics of clinical diagnostic accuracy of SeptiFast determined in this population setting. In addition, this study aims to assess further the preliminary evidence that the detection of pathogen DNA in the bloodstream using SeptiFast may have value in identifying the presence of infection elsewhere in the body. Furthermore, differences in circulating immune-inflammatory markers in patient groups differentiated by the presence/absence of culturable pathogens and pathogen DNA will help elucidate further the patho-physiology of infection developing in the critically ill. Ethics and dissemination: Ethical approval has been granted by the North West 6 Research Ethics Committee (09/H1003/109). Based on the results of this first non-commercial study, independent recommendations will be made to The Department of Health (open-access health technology assessment report) as to whether SeptiFast has sufficient clinical diagnostic accuracy to move forward to efficacy testing during the provision of routine clinical care.

引用

页数：7

共 20 条

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