酶联免疫技术检测乙肝表面抗原的分析性能评价  

Performance evaluation of ELISA in the detection of HBsAg

作　　者：陈桂山[1] 张秀明[1] 熊继红[1] 张汉奎[1] 卢健强[1] 杜满兴[1] 慕月晶[1] 阮小倩[1] 徐全中[1] 

机构地区：[1]中山大学医学院附属中山医院检验科,广东528403

出　　处：《国际检验医学杂志》2011年第9期932-933,共2页International Journal of Laboratory Medicine

摘　　要：目的 评价ALISIE 和 BEPⅢ两台仪器检测乙肝表面抗原（HBsAg）的分析性能和结果的一致性,探讨已知诊断定性实验的性能评价方法.方法 参照临床实验室标准化协会（CLSI）发布的EP12-A2文件对定性试验酶联免疫吸附测定（ELISA）HBsAg的检测进行性能评价,临界值分析物±20%范围的重复性和灵敏度、特异度评价,以及两套分析系统方法学分析性能比较.结果 接近临界值分析物重复性：＋20%浓度临界值分析物检测阳性率大于或等于95%,-20%浓度临界值分析物检测阴性率大于或等于95%;ALISIE灵敏度95.1%、特异性98.3%;BEPⅢ灵敏度92.1%、特异性97.9%.两种方法成对灵敏度/特异性比较：成对灵敏度预测差值-2.96%、成对灵敏度间差异95%CI：-7.32%～1.22%;成对特异性预测差值-0.33%、成对特异性间差异95%CI：-1.69%～2.34%.结论 检测系统ALISIE和BEPⅢ检测HBsAg临界值±20%的浓度范围之外标本,能得到可靠的检测结果,并具有较高的灵敏度和特异性,结果一致性好.Objective To evaluate the performance and conformity of ALISIE and BEPIII in the detection of HBsAg and to investigate the evaluation methods for qualitative tests with diagnosis is known. Methods The reproducibility, sensitivity and specificity of ALISIE and BEPIII were analyzed,when used in the detection of HBsAg within the range of （cut off_＋20% cut off） and the analytic performance of the two systems were compared,according to the CLSI document EP12-A. Results The positive rates of ALISIE and BEPIII were both 95% ,when be utilized for the detection of HBsAg with the concentration of （cut off＋20% cut off）,while the negative rates of them were 100% and 95 %,when he utilized for the detection of HBsAg with the concentration of （cut off--20% cut off）. The sensitivity and specificity of ALISIE were 95.1%%0 and 98.3% ,and of BEPI]I were 92.1% and 97.9%. The estimated difference between paired sensitivity and Specificity were --2.96 % and --0.33 %. The 95 % confidence interval for the difference between paired sensitivites were --7.32 %- 1.22 % and spectificities were -1.69%- 2.3 %. Conclusion Reliable results could be acquired both in ALISIE and BEP III systems,when be utilized in the detection of HBsAg with the concentration a way from the range of （cut off＋20% cut off）,with relatively excellent sensitivity and specificity and with consistent results.

关 键 词：肝炎表面抗原 乙型 诊断 定性试验 性能评价 

分 类 号：R446.6[医药卫生—诊断学]