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

作者：Morinaga Yoshitomo; Akamatsu Norihiko; Matsuda Junichi; Tateno Hiroko; Tomaru Takeshi; Tanaka Ai; Morita Sayuri; Nakamura Makoto; Kato Hideaki; Annaka Megumi; Masuda Yoshishige; Itakura Yasutomo; Inamatsu Takashi; Yanagihara Katsunori

来源：Journal of Infection and Chemotherapy, 2018, 24(2): 88-91.

DOI：10.1016/j.jiac.2017.09.003

• Nucleic acid amplification tests
• Automation
• Molecular diagnosis
• Polymerase chain reaction

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.

• 出版日期2018-2