CLSI EP12-A2文件在HBeAb定性检测性能评价中的应用

检验医学 ›› 2012, Vol. 27 ›› Issue (11): 900-903.

CLSI EP12-A2文件在HBeAb定性检测性能评价中的应用

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

出版日期:2012-11-30 发布日期:2012-11-14
通讯作者: 黄宪章，联系电话：020-81887233-32908。
作者简介:黄妩姣，女，1978年生，硕士，副主任技师，主要从事临床免疫学检验与研究工作。
基金资助:
广东省医学科研基金立项课题（A2011227）

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

1. Department of Clinical Laboratory，Guangdong Provincial Hospital of Traditional Chinese Medicine，Guangdong Guangzhou 510120，China; 2. Department of Clinical Laboratory，Changzhi Medical College，Shanxi Changzhi 046000，China

Online:2012-11-30 Published:2012-11-14

摘要/Abstract

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。

关键词: 性能评价, 定性试验, EP12-A2, 乙型肝炎病毒e抗体

Abstract: 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.

Key words: Performance evaluation, Qualitative test, EP12-A2, Anti-hepatitis B e antigen antibody

黄妩姣1，黄宪章1，庄俊华1，李强1，黄惠1，张强2. CLSI EP12-A2文件在HBeAb定性检测性能评价中的应用[J]. 检验医学, 2012, 27(11): 900-903.

HUANG Wujiao1，HUANG Xianzhang1，ZHUANG Junhua1，LI Qiang1，HUANG Hui1，ZHANG Qiang2. Application of CLSI EP12-A2 document in the performance evaluation of qualitative test of HBeAb[J]. , 2012, 27(11): 900-903.