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
Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
J Infect Chemother. 2018 Feb;24(2):88-91. doi: 10.1016/j.jiac.2017.09.003. Epub 2017 Sep 30.
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.
产毒艰难梭菌的实验室诊断不足可能导致艰难梭菌感染（CDI）的管理不当。使用临床标本对一种全自动分子检测（FAMT）、BD MAX以及针对艰难梭菌谷氨酸脱氢酶（GDH）和毒素A/B抗原检测的酶免疫测定法进行了评估。对231例疑似CDI患者的粪便标本进行实验室分析，结果表明，与产毒培养相比，FAMT的灵敏度（Sn）、特异性（Sp）、阳性预测值（PPV）和阴性预测值（NPV）分别为98.1%、98.9%、96.3%和99.4%，而毒素A/B抗原检测的相应值分别为52.8%、100.0%、100.0%和87.7%。与产毒培养相比，GDH检测的Sn、Sp、PPV和NPV分别为92.5%、94.4%、83.1%和97.7%。FAMT可支持产毒艰难梭菌的准确实验室诊断，并成为CDI适当治疗的有效工具。
