一种新型产毒艰难拟梭菌检测试剂的临床应用研究  

A study on the clinical application of a novel toxigenic Clostridioides difficile detection kit

作　　者：张亚丽[1] 张江峰[2] 刘亚锋 王利英 ZHANG Yali;ZHANG Jiangfeng;LIU Yafeng;WANG Liying(Medical Laboratory,the Second Affliated Hospital of Zhengzhou University,Zhengzhou,Henan 450014,China;Medical Laboratory,Henan Provincial People's Hospital;A utobio Diagnostics Co.,Ltd.)

机构地区：[1]郑州大学第二附属医院检验科,河南郑州450014 [2]河南省人民医院检验科 [3]郑州安图生物工程股份有限公司

出　　处：《现代疾病预防控制》2025年第2期120-124,共5页MODERN DISEASE CONTROL AND PREVENTION

基　　金：河南省科技攻关联合共建项目(LHGJ20230365)。

摘　　要：目的对一种新型产毒艰难拟梭菌的检测试剂进行检测性能和临床样本检验性能评价,为临床选择新型产毒艰难拟梭菌的检测方法提供数据支持。方法采用产毒艰难梭菌检测液(TCD检测液)分别对22株产毒艰难拟梭菌和32株干扰菌(非产毒株和其他可能导致干扰的杂菌)进行检测,评价其检测灵敏度和特异度;采用TCD检测液、C.DIFF QUIK CHEK COMPLETE试剂盒以及Xpert C.difficile试剂盒3种试剂对216份临床粪便样本进行检测,比对不同试剂盒的检测结果,评价TCD检测液的临床样本检验性能。结果TCD检测液对22株产毒艰难拟梭菌的最低检测限至少可达104CFU/m L;对32株干扰菌检测中,30株检测结果均为阴性,仅有双酶梭菌和腐败梭菌检测结果为阳性,特异度约为93.8%。对216份临床粪便样本检测中,与C.DIFF QUIKCHEKCOMPLETE试剂盒方法相比,TCD检测液的灵敏度为94.3%,特异度为97.2%,阳性预测值为86.8%,阴性预测值为98.9%,Kappa分析二者的一致性较好(Kappa=0.885,P<0.05);与Xpert C.difficile试剂盒方法相比,TCD检测液的灵敏度为80.6%,特异度为95.0%,阳性预测值为76.3%,阴性预测值为96.1%,Kappa分析二者的一致性较好(Kappa=0.739,P<0.05)。结论本研究中对于产毒艰难拟梭菌的检测,TCD检测液表现出较好的灵敏度和特异度,与现有临床上常用的检测试剂盒C.DIFF QUIK CHEK COMPLETE和Xpert C.difficile相比,均具有较好的一致性。Objective To evaluate the detection performance and the clinical sample test performance of a novel detection kit for toxigenic Clostridioides difficile,providing data to support its clinical use.Methods The evaluation involved detecting of 22strains of toxigenic Clostridioides difficile and 32 strains of interfering bacteria using TCD detection kit.Clinical performance was assessed by comparing it with the C.DIFF QUIK CHEK COMPLETE kit and Xpert C.difficile kit across 216 clinical stool samples.Results The minimum detection limit for the TCD kit was at least 10~4CFU/m L for the 22 strains of toxigenic Clostridioides difficile.Among 32 interfering bacteria strains,30 tested negative,with only Clostridium bifermentans and Clostridium putrificum yielding positive results,resulting in a specificity of approximately 93.8%.In testing 216 clinical stool samples,TCD had a sensitivity of 94.3%,specificity of 97.2%,positive predictive value of 86.8%,and negative predictive value of 98.9%when compared to C.DIFF QUIK CHEK COMPLETE kit,respectively.Kappa analysis showed strong consistency(Kappa=0.885,P<0.05).When compared to the Xpert C.difficile kits,the sensitivity,specificity,positive predictive value,and negative predictive value of TCD were80.6%,95.0%,76.3%,and 96.1%,respectively.Kappa analysis showed strong consistency(Kappa=0.739,P<0.05).Conclusions The TCD detection kit demonstrated good sensitivity and specificity for detecting toxigenic Clostridioides difficile.It showed strong consistency with commonly used C.DIFF QUIK CHEK COMPLETE kit and Xpert C.difficile kits.

关 键 词：新型 产毒 艰难拟梭菌 检测 TCD检测液 

分 类 号：R446.5[医药卫生—诊断学]