5种国产丙型肝炎病毒抗体胶体金检测试剂评价结果分析  

Analysis of the Evaluation Results of 5 Domestic Hepatitis C Virus Antibody Colloidal Gold Detection Kits

作　　者：宋彩花 李红梅 董贤雅 胡安艳[2] 蔡玮[1] 杨晓娟 Song Caihua;Li Hongmei;Dong Xianya;Hu Anyan;Cai Wei;Yang Xiaojuan(Institute of Medical Biology,Chinese Academy of Medical Sciences Peking Union Medical College,Kunming 650118,China;Baoshan City Disease Control and Prevention Center,Baoshan 678000,China)

机构地区：[1]中国医学科学院北京协和医学院医学生物学研究所,昆明650118 [2]保山市疾病预防控制中心,保山678000

出　　处：《中国药事》2025年第4期439-444,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:评估市场上在售的国产丙型肝炎病毒(HCV)抗体胶体金检测试剂,为抗体筛查检测试剂选择方面提供依据。方法:选择市场上在售的5种国产HCV抗体胶体金检测试剂,对200份阴性样本和141份阳性样本进行检测。结果:GZWF的假阳性率和假阴性率均为0%;YKXC的假阳性率为1%,假阴性率为1.4%;BJWT的假阳性率为2%,假阴性率为1.4%;SHKH的假阳性率为0%,假阴性率为0.7%;HZAB假阳性率为1%,假阴性率为0%。结论:5种国产HCV抗体胶体金检测试剂的敏感性为98%^(1)00%,特异性为98.5%^(1)00%,敏感性和特异性均大于98%,说明总体质量较好,结果可靠,可作为一种快速高效发现丙肝感染者的筛查方法。Objective:To evaluate 5 kinds of domestic anti-HCV Colloidal gold detection kits on the market,so as to provide reference for selecting antibody screening test kits.Methods:200 negative samples and 141positive nucleic acid samples were tested with 5 kinds of domestic rapid diagnostic reagents for HCV antibody.Results:The false positive and false negative rates of GZWF were both 0%;the false positive rate of YKXCwas 1%,and the false negative rate was 1.4%;the false positive rate of BJWT was 2%,and the false negativerate was 1.4%;the false positive rate of SHKH was 0%,and the false negative rate was 0.7%;the false positiverate of HZAB was 1%,and the false negative rate was 0%.Conclusion:The sensitivity of five domesticallyproduced HCV antibody colloidal gold test kits ranges from 98% to 100%,and the specificity is 98.5%-100%.The sensitivity and specificity are greater than 98%.The overall quality is relatively high,and the results arereliable,which can serve as a rapid and efficient screening method for detecting hepatitis C infected individuals.

关 键 词：丙型肝炎病毒 胶体金检测 试剂评价 

分 类 号：R917[医药卫生—药物分析学] R95[医药卫生—药学]