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| 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标准化研究 |
| Study on standardization of quantitative detection platform for BCR-ABL fusion gene as a molecular marker of imatinib mesylate |
| 投稿时间：2023-04-25 修订日期：2023-12-14 |
| DOI： |
| 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 |
| 英文关键词: Breakpoint cluster region-Abelson leukemia virus fusion gene International scale Conversion factor molecular response accuracy |
| 基金项目: |
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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融合基因的分子反应对数值(MR)。结果 准确度标准品WS2和WS3的BCR-ABL融合基因 的MR值的绝对偏差均不超过±0.5个对数数量级,检测限标准品WS4能检出BCR-ABL融合突变阳性,重复性标准品WS1和WS4的BCR-ABL融合基因的MR值的变异系数(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 method using BCR-ABL quantitative standard. Methods: The RNA of standard was extracted and its concentration and purity was determined. Used the different BCR-ABL fusion gene testing kits by digital PCR method and the digital PCR instrument for detection. The molecular response (MR)logarithm of BCR-ABL fusion gene was acquired for quantitative standard. Results: The MR absolute deviation of accuracy standards WS2 and WS3 was not more than ± 0.5 logarithmic orders of magnitude. The detection limit standard WS4 was BCR-ABL positive. The MR coefficient of variation (CV,%) of repeatability standards WS1 and WS4 was less than 3.0%. Conclusion: The accuracy, detection limit and repeatability of BCR-ABL fusion gene quantitative testing kits by digital PCR method can meet the requirement of Industry standards for Breakpoint cluster region-Abelson leukemia virus fusion gene testing kits and provides technical support for the implementation of the standard. |
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