艰难梭菌谷氨酸脱氢酶抗原及毒素检测试剂盒的性能评估

摘要

目的 对新产品艰难梭菌谷氨酸脱氢酶抗原及毒素检测试剂盒(免疫层析法,C.DIFF QUICK CHEK COMPLETE)进行性能评估.方法 收集临床腹泻患者粪便标本130份,对腹泻粪便标本同时进行艰难梭菌毒素A/B检测试剂盒、艰难梭菌谷氨酸脱氢酶抗原及毒素检测试剂盒和毒素培养检测,以金标准毒素培养法结果作为参比标准,评价各种检测方法的敏感性、特异性、阳性预测值和阴性预测值,从而对艰难梭菌谷氨酸脱氢酶抗原及毒素检测试剂盒进行性能评估.结果 毒素培养法检测艰难梭菌的阳性率为13.8%(18/130).与金标准方法相比,艰难梭菌谷氨酸脱氢酶抗原及毒素检测试剂盒的敏感性、特异性、阳性预测值和阴性预测值分别为55.6%、98.2%、83.3%和93.2%,艰难梭菌毒素A/B检测试剂盒的敏感性、特异性、阳性预测值和阴性预测值分别为50.0%、95.6%、64.3%和92.1%.结论 艰难梭菌谷氨酸脱氢酶抗原及毒素检测试剂盒特异性高,阳性预测值较高,且检测周期短,无需特殊仪器平台,可作为医院门、急诊艰难梭菌感染的初筛试剂盒.%Objective To evaluate the performance of C. DIFF QUICK CHEK COMPLETE,which can be used to determine Clostridium dififcile glutamate dehydrogenase antigen and toxin. Methods A total of 130 clinical diarrheal stools were collected. C. DIFF QUICK CHEK COMPLETE,VIDAS Clostridium dififcile Toxin A/B and Clostridium difficile toxin culture were performed according to the manufacturers' instructions. The sensitivities, specificities,positive predictive values and negative predictive values were evaluated. The performance was evaluated,and the results of toxin culture were as standard. Results There were 18 positive cases(13.8%) by toxin culture,and the sensitivity,specificity and positive and negative predictivevalues were 55.6%,98.2%, 83.3% and 93.2%,respectively. For C. DIFF QUICK CHEK COMPLETE,the sensitivity,specificity and positive and negative predictive values were 50.0%,95.6%,64.3% and 92.1%,respectively. Conclusions C. DIFF QUICK CHEK COMPLETE has high specificity and positive predictive value,with short turn-around time,which can be used for screening Clostridium dififcile infection.