Evaluation of a multiplex real-time PCR kit Amplidiag® Bacterial GE in the detection of bacterial pathogens from stool samples

This study evaluated the performance of a new commercially available multiplex real-time PCR kit Amplidiag (R) Bacterial GE in the systematic screening of bacterial pathogens causing gastroenteritis. Stool samples from 1168 patients were analyzed with Amplidiag (R) Bacterial GE, stool culture, and molecular reference tests, and the sensitivity and specificity of Amplidiag (R) Bacterial GE were determined by comparing the results to the reference tests. The evaluation showed good performance for Amplidiag (R) Bacterial GE: sensitivity and specificity of the test was 100/99.7% for Salmonella, 100/99.8% for Yersinia, 98.8/99.2% for Campylobacter, 92.9/100% for Shigella/EIEC, 100/99.9% for EHEC, 92.9/99.8% for ETEC, 98.9/99.2% for EPEC, and 100/99.8% EAEC, respectively. When compared with stool culture, Amplidiag (R) Bacterial GE was found to be more sensitive. This study suggests that Amplidiag (R) Bacterial GE is suitable for screening bacterial pathogens from stool samples. However, this study only demonstrates the performance of Amplidiag (R) Bacterial GE in low endemic settings, as the number of positive findings in this study was relatively low. (C) 2016 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).