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首页> 外文期刊>Journal of Clinical Microbiology >Impact of Strain Type on Detection of Toxigenic Clostridium difficile: Comparison of Molecular Diagnostic and Enzyme Immunoassay Approaches
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Impact of Strain Type on Detection of Toxigenic Clostridium difficile: Comparison of Molecular Diagnostic and Enzyme Immunoassay Approaches

机译：菌株类型对产毒艰难梭菌检测的影响：分子诊断和酶免疫分析方法的比较

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A multicenter clinical trial assessed the performance of the Cepheid Xpert C. difficile assay on stool specimens collected from patients suspected of having Clostridium difficile infection (CDI). A total of 2,296 unformed stool specimens, collected from seven study sites, were tested by Xpert C. difficile enrichment culture followed by cell culture cytotoxicity testing of the isolates (i.e., toxigenic culture with enrichment) and the study sites' standard C. difficile test methods. The methods included enzyme immunoassay (EIA), direct cytotoxin testing, and two- and three-step algorithms using glutamate dehydrogenase (GDH) screening followed by either EIA or EIA and an in-house PCR assay. All C. difficile strains were typed by PCR-ribotyping. Compared to results for toxigenic culture with enrichment, the sensitivity, specificity, and positive and negative predictive values of the Xpert assay were 93.5, 94.0, 73.0, and 98.8%, respectively. The overall sensitivity of the EIAs compared to that of enrichment culture was 60.0%, and the sensitivity of combined GDH algorithms was 72.9%; both were significantly lower than that of Xpert C. difficile (P < 0.001 and P = 0.03, respectively). The sensitivity of the EIA was significantly lower than that of the Xpert C. difficile assay for detection of ribotypes 002, 027, and 106 (P < 0.0001, P < 0.0001, and P = 0.004, respectively, Fisher's exact test), and the sensitivity of GDH algorithms for ribotypes other than 027 was lower than that for Xpert C. difficile (P < 0.001). The Xpert C. difficile assay is a simple, rapid, and accurate method for detection of toxigenic C. difficile in unformed stool specimens and is minimally affected by strain type compared to EIA and GDH-based methods.
机译：一项多中心临床试验评估了造父变星Xemt C的性能。从怀疑患有艰难梭菌感染的患者粪便标本中进行艰难梭菌测定。 Xpert C测试了从七个研究地点收集的总共2296个未成型的粪便标本。艰难梭菌富集培养，然后进行分离株的细胞培养细胞毒性测试（即富集的产毒培养）和研究地点的标准 C。困难的测试方法。这些方法包括酶免疫测定（EIA），直接细胞毒素检测，以及使用谷氨酸脱氢酶（GDH）筛选的两步和三步算法，然后进行EIA或EIA和内部PCR分析。所有 C。通过PCR-核糖体分型法筛选难育菌株。与富集毒素培养的结果相比，Xpert测定的灵敏度，特异性和阳性和阴性预测值分别为93.5、94.0、73.0和98.8％。与富集培养相比，EIA的总体敏感度为60.0％，组合GDH算法的敏感度为72.9％。两者均显着低于Xpert C。艰难（（ P <0.001和 P = 0.03）。 EIA的灵敏度明显低于Xpert C。艰难梭菌测定法检测002、027和106型（ P <0.0001， P <0.0001和 P = 0.004） ，分别是Fisher的精确检验），并且GDH算法对除027以外的其他核糖型的敏感性低于Xpert C。艰难（ P <0.001）。 Xpert C。艰难梭菌测定法是一种检测毒素 C的简单，快速，准确的方法。与基于EIA和GDH的方法相比，未成型的粪便标本中的细菌难感，并且受菌株类型的影响最小。

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