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A和B毒素。尽管FDA没有批准，但现在有一种商业试剂盒可以用于检测患者粪便标本中的A和/或B毒素基因。关于这项测试的唯一可用性能数据是最近一次全国会议上发表的摘要。我们从韩国制造商那里购买了试剂盒，并开始与艰难梭菌传统检测方法培养和毒素A和B的ELISA法进行比较，评估该检测方法的性能。到目前为止，这种商业化检测方法与传统方法相比表现良好。我们将继续进行比较，直到我们用所有方法测试了300个样本。我们已经开发了我们自己的检测艰难梭菌毒素A和B基因的PCR方法，我们计划使用这种方法来解决不同的结果。将进行图表审查，以确定商业诊断聚合酶链式反应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聚合酶链式反应试剂盒的性能。

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.