不同厂家乙型肝炎病毒前S1抗原测定试剂盒分析性能差异  

Differences in the analytical performance of hepatitis B virus pre-S1 antigen detection kits from different manufacturers

作　　者：张金蕊 邢政 孙会芳 刘利晶 ZHANG Jinrui;XING Zheng;SUN Huifang;LIU Lijing(Zhengzhou Autobio Diagnostics CO.,LTD.,Zhengzhou,Henan 450016,China)

机构地区：[1]郑州安图生物工程股份有限公司,河南郑州450016

出　　处：《检验医学与临床》2020年第S01期91-93,共3页Laboratory Medicine and Clinic

摘　　要：目的将安图乙型肝炎病毒前S1抗原检测试剂盒(磁微粒化学发光法)与A厂家乙型肝炎病毒前S1抗原检测试剂盒(酶联免疫吸附测定法)进行临床比对评价。方法对比检验187份已知样本和1357份未知样本,计算两厂家试剂盒的阳性符合率及总符合率;并计算Kappa值,比较二者结果一致性。结果两厂家已知样本的总符合率为97.86%,Kappa值为0.918;未知样本的总符合率为99.78%,Kappa值为0.968。结论两厂家试剂盒一致性较好,安图试剂盒适合在临床上推广使用。Objective To compare and evaluate antu HBV pre-S1 antigen detection kit(magnetic particle chemiluminescence method)and A manufacturer′s hepatitis B pre-S1 antigen detection kit(Enzyme-linked immunosorbent assay method).Methods Compare 187 known samples and 1357 unknown samples and teste to evaluate the positive agreement rate and the total agreement rate,and also the Kappa value was calculated to compare the consistency of the two assays.Results The total agreement rate of two assays for the known samples was 97.86%,Kappa value was 0.918,and that of unknown samples was 99.78%and Kappa value was 0.968.Conclusion The results of the two assays have a high consistency and the Antubio kit is suitable for clinical use.

关 键 词：乙型肝炎病毒前S1抗原检测试剂盒 磁微粒化学发光法 酶联免疫吸附测定法 

分 类 号：R44[医药卫生—诊断学]