BCR⁃ABL融合基因检测试剂盒(荧光PCR法)的评价  

Evaluation of BCR⁃ABL fusion gene detection kit by fluorescent PCR method

作　　者：张文新 曲守方[1] 李丽莉[1] 孙楠[1] 黄传峰[1] 黄杰[1] ZHANG Wenxin;QU Shoufang;LI Lili;SUN Nan;HUANG Chuanfeng;HUANG Jie(National Institutes for Food and Drug Control,Beijing,China,100050)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《分子诊断与治疗杂志》2023年第5期729-732,共4页Journal of Molecular Diagnostics and Therapy

基　　金：国家药品监督管理局医疗器械推荐性行业标准制修订计划项目(I2022114⁃T⁃zjy)。

摘　　要：目的评价不同公司的BCR⁃ABL融合基因检测试剂盒(荧光PCR法)的性能。方法提取BCR⁃ABL定量标准品WS1~WS4的RNA,分别加入BCR⁃ABL反应液和ABL反应液,然后使用荧光定量PCR仪进行检测。通过软件分析获得标准品的BCR⁃ABL融合基因检测结果。结果准确度标准品WS2和WS3的融合比例绝对偏差均不超过±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Ct值变异系数(CV,%)均<5.0%,WS1~WS4标准品的线性相关系数︱r︱不低于0.9800。结论BCR⁃ABL融合基因检测试剂盒(荧光PCR法)能够准确检出BCR⁃ABL定量标准品,符合断裂点簇集区⁃艾贝尔逊白血病病毒(BCR⁃ABL)融合基因检测试剂盒标准的准确度、检出限、重复性和线性要求。Objective To evaluate the quality of BCR⁃ABL fusion gene testing kits based on fluorescent PCR method from different companies.Methods The RNA of the standard samples WS1~WS4 was extracted and added into BCR⁃ABL reaction solution and ABL reaction solution respectively,then detected by the fluorescence quantitative PCR instrument.The BCR⁃ABL fusion gene results of standards were obtained through software analysis.Results The absolute deviations of the fusion ratios of accuracy standards WS2 and WS3 are no more than±0.5 logarithmic order of magnitude.The detection limit standard WS4 can detect positive BCR⁃ABL fusion mutations.The Ct coefficient value of variation(CV%)of the repeatability standards WS1 and WS4 were less than 5.0%.The linear correlation coefficient|r|of WS1~WS4 standards was not less than 0.9800.Conclusion The BCR⁃ABL fusion gene detection kit(fluorescence PCR method)can accurately detect the BCR⁃ABL quantitative standard,which meets the accuracy of the breakpoint cluster region⁃Abelson leukemia virus(BCR⁃ABL)fusion gene detection kit standard,detection limit,repeatability and linearity requirements.

关 键 词：慢性髓性白血病 断裂点簇集区⁃艾贝尔逊白血病病毒融合基因 酪氨酸激酶抑制剂 国际标准化 准确度 

分 类 号：R733.72[医药卫生—肿瘤] R440[医药卫生—临床医学]