抗-HBe中和实验的检测性能评价  

Performance evaluation of neutralization test for anti-HBe detecting

作　　者：石华[1] 于海燕 

机构地区：[1]秦皇岛市第一医院,河北秦皇岛066000 [2]牡丹江市第一医院,黑龙江牡丹江157000

出　　处：《中国卫生检验杂志》2016年第3期384-385,388,共3页Chinese Journal of Health Laboratory Technology

摘　　要：目的参照美国临床实验室标准化协会（CLSI）推荐的方法,对实验室自建抗-HBe中和实验的检测性能进行评价。方法按照EP17—A、EP5—A2、EP12—A2推荐的方法确立实验室自建抗-HBe中和实验的空白限、精密度、C_（50）和C_5~C_（95）区间、符合率等性能指标。结果抗-HBe中和实验的空白限为1.02;浓度为0.5 NCU/ml时的批内精密度为8.7%,日间精密度为12%;浓度为2 NCU/ml时的批内精密度为6.4%,日间精密度为11%;C_（50）为0.15 NCU/ml;符合率为96%。结论抗-HBe中和实验的检测性能均符合要求,本研究所用的评价方案能够全面、准确地反映免疫定性实验的检测性能。Objective To evaluate the performance of the in- house neutralization test for anti- HBe according to protocols recomonded by CLSI. Methods To confirm the limit of blank（ Lo B）,the precision,C_（50） and C_5- C_（95） interval and coincidence rate of the in- house neutralization anti- HBe according to the method recommend by EP17—A,EP5—A2 and EP12—A2.Results The Lo B of test neutralization test for anti- HBe was 1. 02; as the concentration of analyte was 0. 5 NCU / ml,the within- run precision was 8. 7% and the between- run precision was 12%; when the concentration was 2 NCU / ml,the within-run precision was 6. 4%,and the between- run precision was 11%; C_（50） was 0. 15 NCU / ml; the coincidence rate was 96%.Conclusion The performance of the in- house neutralization test for anti- HBe detecting fulfilled the requirements. The protocols of the study can confirm the performance of immuno- qualitative tests comprehensively and accurately.

关 键 词：乙型肝炎病毒e抗体 中和试验 性能评价 

分 类 号：R466.6[医药卫生—临床医学]