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A Multi-Centre Performance Evaluation Study of the Orion GenRead C. difficile Test

This paper is available in a repository.
This paper is available in a repository.

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Abstract

The precision of the Orion GenRead C. difficile test was evaluated by a reproducibility study where the same set of blind coded samples was tested at the manufacturer's site and at two participating laboratories. Only one sample out of the 450 tested samples was reported as false positive due to contamination caused by an operator error. The total percent agreement between the three laboratories was 99.8% (Table 2). The usability of the test was also evaluated in this study. The feedback from the performance evaluation sites was very positive; especially the simple sample preparation protocol with a short hands-on-time (Figure 1), the compact instrument with an easy-to-use graphical user interface, the simple result interpretation and easy maintenance of the instrument received positive feedback. The Orion GenRead system was described as a breakthrough device for the next generation of portable NAATs and one of the first small-scale battery-powered NAATs with high analytical performance. CONCLUSION Based on these results, the Orion GenRead C. difficile test is an easy to use, robust, sensitive and specific method for detecting toxigenic C. difficile in faeces.