靶向药物甲磺酸伊马替尼的分子标志物BCR-ABL融合基因定量检测平台的质量评价方法的研究  

Study on Standardization of Quantitative Detection Platform for BCR-ABL Fusion Gene as a Molecular Marker of Imatinib Mesylate

作　　者：孙楠[1] 李丽莉[1] 张文新 黄杰[1] 曲守方[1] Sun Nan;Li Lili;Zhang Wenxin;Huang Jie;Qu Shoufang(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of In Vitro Diagnostics,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局体外诊断试剂质量研究与评价重点实验室,北京100050

出　　处：《中国药事》2024年第1期58-65,共8页Chinese Pharmaceutical Affairs

摘　　要：目的:使用BCR-ABL定量标准品,评价BCR-ABL融合基因检测试剂盒(数字PCR法)的性能。方法:提取BCR-ABL定量标准品的RNA,测定其浓度和纯度。使用BCR-ABL融合基因定量检测试剂盒(数字PCR法)和数字PCR仪进行检测,得到标准品的BCR-ABL融合基因的分子学反应。结果:用于准确度项目检测的标准品WS2和WS3的BCR-ABL融合基因的MR绝对偏差均不超过±0.5 log,用于检出限项目检测的标准品WS4能检出BCR-ABL融合基因突变阳性,用于重复性项目检测的标准品WS1和WS4的BCR-ABL融合基因的MR的变异系数(CV)均<3.0%。结论:BCR-ABL融合基因定量检测试剂盒(数字PCR法)的准确度、检出限和重复性的性能指标符合制定的《断裂点簇集区-艾贝尔逊白血病病毒(BCR-ABL)融合基因检测试剂盒》标准的相应要求,为标准的实施提供了技术支撑。Objective:To evaluate performance of BCR-ABL fusion gene testing kit by digital PCR method using BCR-ABL quantitative standard.Methods:The RNA of standard was extracted and its concentration and purity was determined.The different BCR-ABL fusion gene testing kits(digital PCR method)and the digital PCR instrument were used for detection.The molecular response of BCR-ABL fusion gene was acquired for quantitative standard.Results:The MR absolute deviation of accuracy standards WS2 and WS3 did not exceed±0.5 log.The detection limit standard WS4 could be detected positive mutation in the BCR-ABL fusion gene.The MR coeffi cient of variation(CV)of repeatability standards WS1 and WS4 was less than 3.0%.Conclusion:The performance indicators of accuracy,detection limit and repeatability of BCR-ABL fusion gene quantitative testing kits(digital PCR method)can all meet the requirements of Industry Standards for Breakpoint Cluster Region-Abelson Leukemia Virus(BCR-ABL)Fusion Gene Testing Kits,providing technical support for the implementation of the standard.

关 键 词：断裂点簇集区-艾贝尔逊白血病病毒融合基因 国际标准化 转化系数 分子学反应 准确度 检出限 重复性 溯源 

分 类 号：R917[医药卫生—药物分析学]