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Novel portable platform Orion GenRead shows great performance in a diagnostic accuracy study

The performance of the Orion GenRead® system has been evaluated against three other routine methods for diagnosing Clostridium difficile in the first peer-reviewed publication on Orion GenRead C. difficile. The Orion GenRead system was found to be rapid, easy and accurate, and to be able to offer state of the art diagnostic support even in settings where health care infrastructure is minimal.

In the study conducted by Hirvonen et al., 1160 faecal samples from patients suspected of having Clostridium difficile infection were analysed using the Orion GenRead C. difficile test system and comparative routine methods in three teaching hospital laboratories in Finland and France. The comparative methods used for the accuracy study were illumigene® C. difficile (Meridian Bioscience), IMDx™ C. difficile for Abbott m2000 (Abbott laboratories) and C. DIFF QUIK CHECK® (Techlab) + Xpert® C. difficile (Cepheid). The precision of the Orion GenRead C. difficile test system was evaluated in a reproducibility study with a set of blind-coded samples.

The overall agreement of the Orion GenRead C. difficile test when compared to the comparative methods was between 96.7% and 98.8%. In the reproducibility study, the total percent agreement between three laboratories was 99.8%.

The authors conclude that 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. They furthermore state, that due to it’s portable format, battery-powered technology and straightforward result reporting, the Orion GenRead platform could enable fast and accurate molecular pathogen detection even in resource-limited or point-of-care settings.

Hirvonen J, Matero P, Siebert C, et al. Novel portable platform for molecular detection of toxigenic Clostridium difficile in faeces: a diagnostic accuracy study. Eur J Clin Microbiol Infect Dis 2016. doi:10.1007/s10096-016-2860-0

Link to the abstract of the article: http://rd.springer.com/article/10.1007/s10096-016-2860-0


Orion GenRead® C. difficile

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Orion GenRead C. difficile is a molecular test intended for detection of toxigenic Clostridium difficile from faecal samples from patients suspected of having C. difficile infection (CDI). Read more: http://www.oriondiagnostica.com/Products/Orion-GenRead/Orion-GenRead-Cdifficile/