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Comparison of BD Max Cdiff and GenomEra C. difficile molecular assays for detection of toxigenic Clostridium difficile from stools in conventional sample containers and in FecalSwabs

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Abstract

In this study, the usability and performance of GenomEra™ C. difficile and BD Max™ Cdiff nucleic acid amplification tests (NAATs) for the detection of toxigenic Clostridium difficile were investigated in comparison with toxigenic culture and C. difficile toxin A- and toxin B-detecting immunochromatographic antigen (IA) test, the Tox A/B QuikChek®. In total, 302 faecal specimens were collected, 113 of which were in parallel to conventional sample containers and FecalSwab liquid-based microbiology (LBM) tubes. Seventy-nine specimens were considered true-positives for toxigenic C. difficile. The sensitivity and specificity were 97.5 % and 99.6 % and 93.7 % and 98.7 % for the GenomEra and BD Max assays respectively. Toxigenic culture and Tox A/B QuikChek had sensitivity and specificity of 91.1 % and 100 % and 34.2 % and 100 % respectively. Hands-on time for analysing 1 to 24 specimens using NAATs was 1 to 15 min. The rate of PCR inhibition was 0 % for both NAATs with faeces in LBM tubes, while with faeces in conventional sample containers the respective inhibition rates were 5.3 % and 4.4 % for the GenomEra and the BD Max assays. The NAATs demonstrated an excellent analytical performance, reducing significantly the overall workload of laboratory personnel compared with culture and IA test.

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Acknowledgements

Nancy Lahtinen, Mikaela Eur, and Marianne Nynäs are gratefully acknowledged for their help in sample preparations and workload analysis. We have no conflicts of interests to declare.

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Authors and Affiliations

  1. Department of Clinical Microbiology, Vaasa Central Hospital, Hietalahdenkatu 2-4 B2, 65130, Vaasa, Finland

    J. J. Hirvonen & S.-S. Kaukoranta

  2. Fimlab Laboratories, Biokatu 4, 33520, Tampere, Finland

    J. J. Hirvonen

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  1. J. J. Hirvonen
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Correspondence to J. J. Hirvonen.

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Hirvonen, J.J., Kaukoranta, SS. Comparison of BD Max Cdiff and GenomEra C. difficile molecular assays for detection of toxigenic Clostridium difficile from stools in conventional sample containers and in FecalSwabs. Eur J Clin Microbiol Infect Dis 34, 1005–1009 (2015). https://doi.org/10.1007/s10096-015-2320-2

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