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用于检测产毒艰难梭菌的Verigene艰难梭菌检测法、Simplexa艰难梭菌通用直接检测法、BD MAX艰难梭菌检测法和Xpert艰难梭菌检测法的比较

Comparison of the Verigene Clostridium difficile, Simplexa C. difficile Universal Direct, BD MAX Cdiff, and Xpert C. difficile assays for the detection of toxigenic C. difficile.

作者信息

Gilbreath Jeremy J, Verma Punam, Abbott April N, Butler-Wu Susan M

机构信息

Department of Laboratory Medicine, University of Washington, Seattle, WA 98195.

Department of Pathology and Clinical Laboratories, Virginia Mason Medical Center, Seattle, WA 98101.

出版信息

Diagn Microbiol Infect Dis. 2014 Sep;80(1):13-8. doi: 10.1016/j.diagmicrobio.2014.06.001. Epub 2014 Jun 7.

Abstract

We compared the Verigene Clostridium difficile test (Nanosphere, Northbrook, IL, USA), the Simplexa C. difficile Universal Direct (Focus Diagnostics, Cypress, CA, USA), the BD MAX Cdiff (Becton Dickinson, Franklin Lakes, NJ, USA), and the Xpert C. difficile (Cepheid, Sunnyvale, CA, USA) assays for the detection of toxigenic C. difficile. One hundred and ninety deidentified, remnant diarrheal specimens were included in this study. After resolution of discordant results by toxigenic culture, the Xpert C. difficile assay displayed the highest sensitivity (100%), with a specificity of 98.8%. The sensitivity and specificity were 95.2% and 99.4% and 87% and 100% for the Verigene CDF and Simplexa Universal Direct assays, respectively. Finally, the BD MAX assay showed a sensitivity of 87% and a specificity of 98.8%. Despite differences in the overall performance of these assays, these results support the routine use of these platforms for the detection of toxigenic C. difficile in the clinical laboratory.

摘要

我们比较了Verigene艰难梭菌检测法(美国伊利诺伊州诺斯布鲁克市Nanosphere公司)、Simplexa艰难梭菌通用直接检测法(美国加利福尼亚州赛普里斯市Focus Diagnostics公司)、BD MAX艰难梭菌检测法(美国新泽西州富兰克林湖市Becton Dickinson公司)以及Xpert艰难梭菌检测法(美国加利福尼亚州森尼韦尔市Cepheid公司)检测产毒艰难梭菌的情况。本研究纳入了190份经过去标识化处理的剩余腹泻标本。通过产毒培养解决结果不一致的问题后,Xpert艰难梭菌检测法显示出最高的灵敏度(100%),特异性为98.8%。Verigene CDF检测法和Simplexa通用直接检测法的灵敏度和特异性分别为95.2%和99.4%以及87%和100%。最后,BD MAX检测法的灵敏度为87%,特异性为98.8%。尽管这些检测法的总体性能存在差异,但这些结果支持在临床实验室中常规使用这些平台来检测产毒艰难梭菌。

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