2004年湖北省内使用的HIV抗体ELISA诊断试剂的评估分析  

Evaluation of HIV antibody ELISA kits used in Hubei province in 2004

作　　者：戴涌[1] 陈慧萍[1] 汤恒[1] 彭庭海[1] 魏锐[1] 

机构地区：[1]湖北省疾病预防控制中心,武汉430079

出　　处：《江西医药》2005年第10期623-624,共2页Jiangxi Medical Journal

摘　　要：目的通过对艾滋病病毒(HIV)抗体检测诊断试剂的质量评估,筛选检测性能好的试剂,为艾滋病临床检测提供选择依据。方法用湖北省艾滋病性病防治中心确认实验室提供的199份样品,用明胶凝集法和蛋白印迹法来评价四个厂家的HIV抗体ELISA诊断试剂的敏感性、特异性。结果被评价的各种检测诊断试剂敏感性在96.67～100.00%之间,特异性在91.72～95.86%之间,功效率92.46～95.98%之间。结论HIV抗体检测诊断试剂有较好的检测性能,国产试剂敏感性和特异性与进口试剂相差不大,适合在中国市场作为临床诊断中使用。Objective To evaluate the quality of HIV ELISA diagnostic kits in order to provide selection refereace for HIV clinical test. Methods To use PA to retest and western blot to confirm the preliminary testing results of four ELISA diagnostic klts,then to compare the sensitivities and specificities of the four kits. Results The sensitivities of the four kits were between 96.67～100.00%, specificities between 91.72～95.86% and efficacies between 92.46～95,98%. Conclusions These four HIV antibody ELISA diagnosic kits have good quality, the sensitivities and specificities of both domestic ELISA kits and foreigh ELISA kits are almost the same ,and these ELISA kits can be used for clinical diagnosis in China.

关 键 词：艾滋病病毒 ELISA 诊断试剂 评估 

分 类 号：R446.61[医药卫生—诊断学]