CLSI EP12-A2文件在HBeAb定性检测性能评价中的应用  

Application of CLSI EP12-A2 document in the performance evaluation of qualitative test of HBeAb

作　　者：黄妩姣[1] 黄宪章[1] 庄俊华[1] 李强[1] 黄惠[1] 张强[2] 

机构地区：[1]广东省中医院检验科,广东广州510120 [2]山西长治医学院检验系,山西长治046000

出　　处：《检验医学》2012年第11期900-903,共4页Laboratory Medicine

基　　金：广东省医学科研基金立项课题(A2011227)

摘　　要：目的对A和B 2种定性检测人血清抗乙型肝炎病毒e抗体(HBeAb)的酶联免疫吸附试验(ELISA)试剂盒进行评估,为实验室选择合适的HBeAb试剂提供实验依据。方法参照美国临床实验室标准化协会(CLSI)EP12-A2文件推荐方法,对A和B 2种HBeAb检测试剂做偏倚和不精密度分析,比较2种HBeAb检测试剂的C50、C5～C95区间以及不精密度曲线。用2种试剂同时检测910份标本的HBeAb,计算检测结果一致程度的95%可信区间(CI),计算(Kappa)值,评价一致性。结果 A试剂检测血清HBeAb的C50小于B试剂的C50,A试剂的C5～C95区间比B试剂的窄,A试剂的不精密度曲线比B试剂的陡峭;2种试剂检测标本HBeAb一致程度的95%CI为93.2%～96.1%,Kappa值约0.87。结论 EP12-A2作为定性检测的性能评价方法可行。Objective To evaluate A and B ELISA kits for detecting qualitatively anti-hepatitis B e antigen antibody（HBeAb）,and to provide useful reference for choosing suitable HBeAb kits.Methods According to Clinical and Laboratory Standards Institute（CLSI） EP12-A2 document,the bias and imprecision of A and B HBeAb kits were analyzed,and their C50,C5-C95 intervals and imprecision curves were compared.The HBeAb of 910 specimens were simultaneously determined by both A and B kits.The 95% confidence interval（CI）for concordance was calculated.The Kappa value was calculated to evaluate their concordance.Results C50 for A kit was less than that for B kit.C5-C95 interval of A kit was narrower than that of B kit.The imprecision curve of A kit was steeper than that of B kit.The 95% CI for concordance was calculated as 93.2%-96.1%,and the Kappa value was 0.87.Conclusions EP12-A2 is a useful protocol for the evaluation of qualitative test performance.

关 键 词：性能评价 定性试验 EP12-A2 乙型肝炎病毒e抗体 

分 类 号：R195.1[医药卫生—卫生统计学]