National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China; Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, People's Republic of China; Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, People's Republic of China.
Department of Nuclear Medicine, First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China.
Exp Hematol. 2020 Jan;81:42-49.e3. doi: 10.1016/j.exphem.2019.12.002. Epub 2019 Dec 18.
For patients with chronic myeloid leukemia, reverse transcription quantitative polymerase chain reaction is widely used in laboratories to quantify BCR-ABL1 fusion gene transcripts for disease management. Many efforts have been made to standardize the BCR-ABL1 testing assay, including the primary and secondary reference reagents, but the secondary standards have not been developed and used in the standardization program in China. With the use of armored RNA technology, armored RNA of BCR-ABL1 and control genes was manufactured to prepare the secondary reference material anchored to the World Health Organization primary reference calibrators for standardization of BCR-ABL1 testing assays. The secondary reference was sent to 30 laboratories in China for validation. Data from an external quality assessment after the standardization process were collected and analyzed as well. The assigned %BCR-ABL1/ABL1 values of the four levels of the secondary material panels were 0.0118, 0.1345, 1.3808, and 19.4266, respectively. In validation trials, 70.0% (21/30) of laboratories obtained valid conversion factors for the BCR-ABL1 assay. All valid conversion factors from 11 international scale laboratories were equivalent to their respective previous values. External quality assessment data indicated that the accuracy and precision between laboratories were improved. Moreover, the quantity of the panels is abundant to be used as quality control samples for monitoring the shift of data. In this study, we established a secondary genetic reference panel for BCR-ABL1 quantification. This study will play a role in facilitating the worldwide dissemination of the international scale, especially in promoting the standardization of molecular monitoring in China.
对于慢性髓性白血病患者，逆转录定量聚合酶链反应广泛应用于实验室，以量化 BCR-ABL1 融合基因转录本，用于疾病管理。已经做出许多努力来标准化 BCR-ABL1 检测分析，包括初级和次级参考试剂，但在中国的标准化计划中尚未开发和使用次级标准。利用装甲 RNA 技术，制造了 BCR-ABL1 和对照基因的装甲 RNA，以制备锚定在世界卫生组织初级参考校准物上的二级参考物质，用于 BCR-ABL1 检测分析的标准化。该二级标准被分发给中国的 30 个实验室进行验证。在标准化过程后收集和分析了外部质量评估的数据。四个水平的次级材料面板的分配 %BCR-ABL1/ABL1 值分别为 0.0118、0.1345、1.3808 和 19.4266。在验证试验中，70.0%（21/30）的实验室获得了有效的 BCR-ABL1 分析转换因子。来自 11 个国际标准实验室的所有有效转换因子都与其之前的值等效。外部质量评估数据表明，实验室之间的准确性和精密度得到了提高。此外，面板的数量充足，可以用作质量控制样本，以监测数据的变化。在这项研究中，我们建立了用于 BCR-ABL1 定量的二级遗传参考面板。这项研究将有助于促进国际标准的全球传播，特别是在中国推动分子监测的标准化。
