Commercial PCR Assay For Diagnosis C. difficile Colitis

直到最近，唯一可用于诊断艰难梭菌相关性腹泻的商业检测方法是检测毒素A和B。尽管FDA尚未批准，但现在有一种商业试剂盒可用于巢式PCR检测患者粪便标本中的毒素A和/或B基因。关于该分析的唯一可用性能数据是在最近一次全国会议上发表的摘要中。我们从韩国制造商购买了试剂盒，并开始与传统的艰难梭菌检测方法培养和毒素A和b的ELISA相比较，评估该检测方法的性能。到目前为止，该商业检测方法与传统方法相比效果良好。我们将继续比较，直到用各种方法测试了300个标本。我们已经开发了自己的PCR方法来检测艰难梭菌毒素A和B基因，我们计划使用这种方法来解决差异的结果。将进行图表审查，以确定商业诊断PCR试剂盒产生的结果的临床相关性。到目前为止，还没有发表的文章描述这种PCR试剂盒的性能。

Until recently, the only commercially available tests for diagnosis of Clostridium difficile-associated diarrhea were assays for the detection of toxins A and B. Although not FDA approved, there is now a commercially available kit to perform nested PCR for detection of toxin A and/or B genes in patient stool specimens. The only available performance data regarding this assay is in a published abstract from a recent national meeting. We purchased kits from the Korean manufacturer and have begun to evaluate the performance of the assay compared to the traditional C. difficile detection methods culture and an ELISA for toxins A and B. So far, this commercial assay compares well with the traditional methods. We will continue our comparison until we have tested 300 specimens by all methods. We have developed our own PCR assay for the detection of C. difficile toxin A and B genes and we plan on using this assay to resolve discrepant results. A chart review will be peformed to determine the clinical relevance of results generated by the commercial diagnostic PCR kit. To date there are no published articles describing the performance of this PCR kit.