caa a22 4500 606157638 CHVBK 20210128100614.0 cr unu---uuuuu 210128e20150501xx s 000 0 eng 10.1007/s10096-015-2320-2 doi (NATIONALLICENCE)springer-10.1007/s10096-015-2320-2 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 [Elektronische Daten] [J. Hirvonen, S.-S. Kaukoranta] 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 15min. 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. Springer-Verlag Berlin Heidelberg, 2015 Hirvonen J. Department of Clinical Microbiology, Vaasa Central Hospital, Hietalahdenkatu 2-4 B2, 65130, Vaasa, Finland aut Kaukoranta S.-S Department of Clinical Microbiology, Vaasa Central Hospital, Hietalahdenkatu 2-4 B2, 65130, Vaasa, Finland aut European Journal of Clinical Microbiology & Infectious Diseases Springer Berlin Heidelberg 34/5(2015-05-01), 1005-1009 0934-9723 34:5<1005 2015 34 10096 https://doi.org/10.1007/s10096-015-2320-2 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10096-015-2320-2 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Hirvonen J. Department of Clinical Microbiology, Vaasa Central Hospital, Hietalahdenkatu 2-4 B2, 65130, Vaasa, Finland aut NATIONALLICENCE 700 1- Kaukoranta S.-S Department of Clinical Microbiology, Vaasa Central Hospital, Hietalahdenkatu 2-4 B2, 65130, Vaasa, Finland aut NATIONALLICENCE 773 0- European Journal of Clinical Microbiology & Infectious Diseases Springer Berlin Heidelberg 34/5(2015-05-01), 1005-1009 0934-9723 34:5<1005 2015 34 10096