Novel portable platform for molecular detection of toxigenic Clostridium difficile in faeces : a diagnostic accuracy study

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Hirvonen , J J , Matero , P , Siebert , C , Kauppila , J , Vuento , R , Tuokko , H & Boisset , S 2017 , ' Novel portable platform for molecular detection of toxigenic Clostridium difficile in faeces : a diagnostic accuracy study ' , European Journal of Clinical Microbiology & Infectious Diseases , vol. 36 , no. 5 , pp. 783-789 . https://doi.org/10.1007/s10096-016-2860-0

Title: Novel portable platform for molecular detection of toxigenic Clostridium difficile in faeces : a diagnostic accuracy study
Author: Hirvonen, J. J.; Matero, Pirjo; Siebert, C.; Kauppila, J.; Vuento, R.; Tuokko, H.; Boisset, S.
Contributor organization: Medicum
Department of Bacteriology and Immunology
Date: 2017-05
Language: eng
Number of pages: 7
Belongs to series: European Journal of Clinical Microbiology & Infectious Diseases
ISSN: 0934-9723
DOI: https://doi.org/10.1007/s10096-016-2860-0
URI: http://hdl.handle.net/10138/236793
Abstract: Background A novel portable platform for nucleic acid amplification enables rapid detection of diarrhoea causing toxigenic Clostridium difficile directly from faeces, even in resource-limited settings. We evaluated the accuracy and precision of the new commercial molecular test system. Methods One thousand one hundred and sixty faecal samples from patients suspected of having Clostridium difficile infection (CDI) were analysed using the Orion GenRead C. difficile test system (Orion Diagnostica Oy, Espoo, Finland) and comparative methods in three teaching hospital laboratories in Finland and France. The precision of the Orion GenRead C. difficile test system was evaluated in a reproducibility study with a set of blind-coded samples. The test system is based on a new isothermal amplification technology (Strand Invasion Based Amplification, SIBA (R)) and detection of the tcdB gene of C. difficile. We calculated the sensitivity, specificity, and the overall agreement according to Clinical and Laboratory Standards Institute recommendations. Findings The overall agreement of the Orion GenRead C. difficile test when compared to the comparative methods in routine use in the participating laboratories was between 96.7% and 98.8%. In the reproducibility study; the total percent agreement between three laboratories was 99.8%. Interpretation The identification of toxigenic C. difficile from faeces with the light-weight portable Orion GenRead test system was highly sensitive and specific, and the results were reproducible in the participating laboratories. This platform could enable fast and accurate molecular pathogen detection even in resource-limited or point-of-care settings.
Subject: BD MAX CDIFF
EMERGING TECHNOLOGIES
DEVELOPING-WORLD
C.-DIFFICILE
RISK-FACTORS
INFECTION
COLONIZATION
PREVALENCE
CARRIAGE
DIARRHEA
3121 General medicine, internal medicine and other clinical medicine
1183 Plant biology, microbiology, virology
Peer reviewed: Yes
Usage restriction: openAccess
Self-archived version: publishedVersion


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