Department of Clinical and Molecular Microbiology, Affiliated Laboratory, Inc, Bangor, ME 04401, USA.
Diagn Microbiol Infect Dis. 2012 Jan;72(1):8-13. doi: 10.1016/j.diagmicrobio.2011.09.008. Epub 2011 Oct 19.
Clostridium difficile is the most common and important cause of toxigenic colitis in the health care setting. Laboratory diagnostics have included bacterial culture with further identification of toxigenic stains, or more commonly, direct detection of preformed toxin in stool samples using biological or immunochemistry assays. Recently, molecular amplification assays for the direct detection of toxin-encoding genes have become available commercially. We prospectively evaluated 2 FDA-cleared molecular amplification tests, the Illumigene C. difficile and the ProGastro Cd PCR assay, for the direct detection of toxigenic C. difficile from fecal samples. Of 446 samples tested, 418 produced matching amplification results, 88 positive and 330 negative, and 13 resolved with repeat testing. Toxigenic culture and direct cytotoxin testing were used to resolve the remaining 15 discordant samples. Overall, each assay performed well and correctly identified 97% of positive samples.
艰难梭菌是医疗环境中产生毒素的结肠炎的最常见和最重要的原因。实验室诊断包括细菌培养，进一步鉴定产毒株，或者更常见的是，使用生物或免疫化学检测法直接检测粪便样本中预先形成的毒素。最近，用于直接检测编码毒素基因的分子扩增检测法已在商业上获得批准。我们前瞻性地评估了 2 种经过 FDA 批准的分子扩增检测法，即 Illumigene C. difficile 和 ProGastro Cd PCR 检测法，用于直接从粪便样本中检测产毒艰难梭菌。在检测的 446 个样本中，418 个产生了匹配的扩增结果，88 个阳性和 330 个阴性，13 个通过重复检测解决。产毒培养和直接细胞毒素检测用于解决其余 15 个不一致的样本。总的来说，每个检测法都表现良好，正确识别了 97%的阳性样本。
