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

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。采用该试剂盒搭配数字 PCR 仪检测，获取标准品 BCR-ABL 融合基因分子学反应结果。

结果：

准确度检测样品 WS2、WS3 的 BCR-ABL 融合基因 MR 绝对偏差均不超过±0.5 log；检出限样品 WS4 可检出融合基因阳性；重复性样品 WS1、WS4 对应的 MR 变异系数均小于3.0 %。

结论：

该试剂盒准确度、检出限、重复性指标均符合《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》相关标准要求，可为标准落地实施提供技术支撑。

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 BCR-ABL fusion gene testing kit (digital PCR method) and digital PCR instrument were adopted for detection, and the molecular response level of BCR-ABL fusion gene of the quantitative standard was obtained.

Results: 

The MR absolute deviation of accuracy standards WS2 and WS3 did not exceed ±0.5 log. The detection limit standard WS4 showed positive results of BCR-ABL fusion gene. The coefficient of variation (CV) of MR for repeatability standards WS1 and WS4 was less than 3.0 %.

Conclusion: 

The performance indicators including accuracy, detection limit and repeatability of the BCR-ABL fusion gene quantitative testing kit (digital PCR method) meet relevant standard requirements, providing technical support for standard implementation.