Commercial PCR Assay For Diagnosis C. difficile Colitis

用于诊断艰难梭菌结肠炎的商业 PCR 检测

• 批准号: 6675240
• 负责人: DANIEL P. FEDORKO
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6675240
• 关键词: Clostridium difficile; bacterial disease; bacterial genetics; bacterial toxins; colitis; diagnosis design /evaluation; diagnostic tests; diarrhea; feces analysis; gastrointestinal disorder diagnosis; genetic screening; human tissue; polymerase chain reaction

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.

直到最近，用于诊断艰难梭菌相关性腹泻的唯一市售检测是用于检测毒素A和B的测定。虽然没有FDA批准，但现在有一种市售的试剂盒来进行巢式PCR，用于检测患者粪便标本中的毒素A和/或B基因。关于该检测试剂盒的唯一可用性能数据见最近一次国家会议的已发表摘要。我们从韩国制造商购买试剂盒，并已开始评估与传统C.艰难梭菌检测方法培养和毒素A和B的ELISA。到目前为止，这种商业化的测定方法与传统方法相比效果良好。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PCR检测C。艰难梭菌毒素A和B基因，我们计划使用该检测来解决不一致的结果。将进行图表审查，以确定市售诊断PCR试剂盒生成的结果的临床相关性。迄今为止，尚未发表文章描述该PCR试剂盒的性能。