Diagnostic utilities of a fully automated molecular test for toxigenic Clostridium difficile

Publication date: Available online 30 September 2017
Source:Journal of Infection and Chemotherapy
Author(s): Yoshitomo Morinaga, Norihiko Akamatsu, Junichi Matsuda, Hiroko Tateno, Takeshi Tomaru, Ai Tanaka, Sayuri Morita, Makoto Nakamura, Hideaki Kato, Megumi Annaka, Yoshishige Masuda, Yasutomo Itakura, Takashi Inamatsu, Katsunori Yanagihara
Laboratory underdiagnosis of toxigenic Clostridium difficile can lead to inappropriate management of C. difficile infection (CDI). A fully automated molecular test (FAMT), BD MAX, and enzyme immunoassays for C. difficile glutamate dehydrogenase (GDH) and for toxin A/B antigen test were evaluated using clinical specimens. Laboratory analysis of 231 fecal specimens from patients suspected with CDI, indicated that the sensitivity (Sn), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV) of FAMT was 98.1%, 98.9%, 96.3%, and 99.4%, while that of toxin A/B antigen was 52.8%, 100.0%, 100.0%, and 87.7%, respectively, compared to toxigenic culture. Sn, Sp, PPV, and NPV of GDH test compared to toxigenic culture was 92.5%, 94.4%, 83.1%, and 97.7%, respectively. FAMT can support the accurate laboratory diagnosis of toxigenic C. difficile and be an effective tool for appropriate treatment of CDI.



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