Novel portable platform for molecular detection of toxigenic Clostridium difficile in faeces: a diagnostic accuracy study
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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.
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®) 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.
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%.
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.
KeywordsNucleic Acid Amplification Test Rapid Diagnostic Test Result Toxigenic Culture Nucleic Acid Amplification Technology Xpert Assay
We are grateful to all Nordlab Oulu, Fimlab Laboratories, and CHU clinical and laboratory staff who helped conducting the study; especially, we thank Liisa Venho, Marika Huttu, Sari Ansaranta, and Tiina Malila for excellent technical assistance in conducting the analyses of the clinical specimens. We also thank Orion Diagnostica for providing the instrument and reagents for the Orion GenRead test system.
Compliance with ethical standards
This study was not funded by any external party. The study was performed using the clinical microbiology services of Nordlab Oulu, Fimlab Laboratories, and Grenoble CHU.
Conflicts of interest
Pirjo Matero has been employed by Orion Diagnostica since June 2010. At present, Pirjo Matero is on a leave of absence from Orion Diagnostica to conduct PhD studies at the University of Helsinki. The other authors have no conflict of interest to declare.
Neither human participants nor animals were involved in this study.
All authors have seen and approved the content and have contributed significantly to the work. Jari J. Hirvonen and Pirjo Matero have contributed equally to the designing and supervising the study, analyzing and interpreting the data, and writing and editing of the manuscript. Risto Vuento, Hanna Tuokko, and Jaana Kauppila have contributed in supervising the study, analyzing and interpreting the data, and critically reviewing the manuscript. Claire Siebert took part in analysing and interpratation of the data. Sandrine Boisset took part in designing and supervising the study, analyzing, and interpreting the data, and writing and critically reviewing the manuscript.
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