趋势分析法评价乙型肝炎病毒表面抗原诊断试剂的质量  

Evaluation of quality of diagnostic kit for hepatitis B virus surface antigen by trend analysis

作　　者：辜文洁[1] 蓝海云[1] 吴星[1] 李克坚[1] 姚昕[1] 周诚[1] 梁争论[1] 

机构地区：[1]中国食品药品检定研究院卫生部生物技术产品检定及标准化重点实验室,北京100050

出　　处：《中国生物制品学杂志》2014年第8期1076-1080,共5页Chinese Journal of Biologicals

基　　金：国家"十二五"艾滋病和病毒性肝炎等重大传染病防治科技重大专项(2012ZX10004701)

摘　　要：目的 应用趋势分析法评价我国乙型肝炎病毒表面抗原诊断试剂质量。方法 采用同一批次国家参考品进行批批检验,且检验均合格的乙型肝炎病毒表面抗原诊断试剂A、B、C、D的数据,对不同血清型、不同浓度样品的检测结果进行趋势分析,以理论平均值依2SD为警戒限,平均值依3SD为行动限,将检测结果超出行动限、连续3批检验结果超出警戒限或检验结果趋势有严重漂移（连续6批结果上升或下降或连续8批结果在均值同一侧）暂定为偏离数据,观察诊断试剂的各检测指标的变化趋势。结果 在2011年3月～2013年5月的观察时间内,A、B、C试剂均出现8～10批次数据在均值同侧的情况,判定为存在偏离数据;D试剂质量稳定,未出现试验数据严重漂移的批次。结论 趋势分析可反映乙型肝炎病毒诊断试剂质量的变化,为保证试剂质量的稳定提供了方法。Objective To evaluate the quality of domestic diagnostic kit for hepatitis B virus surface antigen（HBsAg）by trend analysis. Methods The lot release data of diagnostic kit for HBsAg,collected from four manufacturers using the same batch of national standard,were analyzed retrospectively. Trend analysis was performed on the determination results of test samples of various serotypes at various concentrations. The value of mean ± 2 SD was used as the warning threshold,while the value of mean ± 3 SD as the action threshold. The change trends of quality indexes of the kits were observed. The data were defined as deviation from the data set if the determination result was beyond the action threshold,the determination results of three consecutive batches of samples were beyond the warning threshold or the determination result showed a trend of severe drift（the determination results of six consecutive batches of samples increase or decrease,or those of eight consecutive batches are on the same side of mean）. Results During an observation period from March 2011 to May 2013,the determination results of 8 ~ 10 batches of kits A,B and C were on the same side of mean,indicating deviation of data. However,no severe data drift was observed in any batch of kit D. Conclusion Trend analysis reflected the change of quality of diagnostic kit for HBsAg,which provided a tool for ensuring the stability of quality of the kit.

关 键 词：肝炎病毒 乙型 诊断试剂 趋势分析 

分 类 号：R373.21[医药卫生—病原生物学] R392-33[医药卫生—基础医学]