五种国产乙型肝炎病毒表面抗原试剂盒的评价  

Quality Evaluation on Five Different Enzyme Immuoassay Kits for Hepatitis B Virus Surface Antigen

作　　者：张传兴[1] 刘燕[1] 颜丙玉[2] 刘晓波[1] 张毅[1] 

机构地区：[1]山东省血液中心,山东济南250014 [2]山东省疾病预防控制中心,山东济南250014

出　　处：《预防医学论坛》2011年第8期715-716,740,共3页Preventive Medicine Tribune

摘　　要：[目的]评价5种乙肝病毒表面抗原(HBsAg)诊断试剂盒,筛选高质量的诊断试剂,确保血样HBsAg检测结果准确无误。[方法]5种HBsAg试剂盒均采用ELISA方法,对购买的国家参考品和收集的180份临床血浆标本进行检测,分别与参考品标准和本单位经北京万泰和上海科华双试剂检测一致的结果比较。[结果]5种试剂对灵敏度和精密度参考品的检测均符合要求;检测23份参考品结果的总符合率为96.52%,阳性符合率为100.00%,阴性符合率为96.00%;检测180份临床标本,总符合率为98.56%,阳性符合率为99.00%,阴性符合率为98.67%;检测阳性临床标本的δ值为-6.55(C)^-37.61(E);检测阴性临床标本的δ值为0.92(A)~1.65(E)。[结论]5种试剂在灵敏度、特异性、符合性、准确性方面存在差异,综合评价C试剂质量最符合要求。[Objective]To evaluate five commercial diagnostic kits for detection of HBsAg.[Methods]Samples including standard serum and 180 blood donor＇s samples were detected by the five kits using ELISA method.[Results]All the five kits showed good sensitivity and accuracy.For 23 national reference samples,the positive,negative and total consistency rates were 100.00%,96.00% and 96.52% respectively.The positive,negative and total consistency rates of 180 clinical samples were 99.00%,98.67% and 98.56%.The δ value ranged from-6.55（C） to-37.61 for positive clinical samples,and from 0.92（A）to 1.65（E）for negative samples.[Conclusion]There are differences in the quality of different reagent kits,such as sensitivity,accuracy,specificity and consistency rate.And C Kit is the best.

关 键 词：乙型肝炎病毒表面抗原 评价 诊断试剂 

分 类 号：R512.62[医药卫生—内科学]