孙楠,李丽莉,张文新,黄杰,曲守方.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[J].中国药事,2024,38(1):58-65 |
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-ABLFusion Gene as a Molecular Marker of Imatinib Mesylate |
投稿时间:2023-04-25 |
DOI:10.16153/j.1002-7777.2024.01.008 |
中文关键词: 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 |
英文关键词: Breakpoint cluster region-Abelson leukemia virus fusion gene international standardization conversion factor molecular response accuracy detection limit repeatability traceability |
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中文摘要: |
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。 |
英文摘要: |
Objective: To evaluate performance of BCR-ABL fusion gene testing kit by digital PCR methodusing BCR-ABL quantitative standard. Methods: The RNA of standard was extracted and its concentration andpurity was determined. The different BCR-ABL fusion gene testing kits (digital PCR method) and the digitalPCR instrument were used for detection. The molecular response of BCR-ABL fusion gene was acquired forquantitative 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 quantitativetesting 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 theimplementation of the standard. |
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