Yu Shuping, Cui Ming, He Xiao, Jing Rongrong, Wang Huimin
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Clin Chem Lab Med. 2017 Aug 28;55(10):1465-1473. doi: 10.1515/cclm-2016-0927.
Breakpoint cluster region-Abelson (BCR-ABL1) translocation is the characteristic sign of chronic myeloid leukemia (CML). The quantitation of BCR-ABL1 messenger RNA is requisite for patients with CML, and reverse-transcription real-time quantitative polymerase chain reaction (RQ-PCR) is the method used most extensively in testing laboratories worldwide. Nevertheless, substantial variation in RQ-PCR results from different laboratories makes interlaboratory comparability inconvincible owing to the lack of standardization. To facilitate interlaboratory comparative assessment and international standardization, an international scale (IS) for BCR-ABL1 was proposed. The laboratory-specific conversion factors derived from the IS can convert local different values to the IS without changing procedures. The standardization of BCR-ABL1 also includes the whole analytical process, so it is noteworthy to pay attention to the quality control before BCR-ABL1 quantitative analysis. More importantly, the World Health Organization has validated a first genetic reference panel which is limited to the manufacturers to produce and calibrate secondary reference reagents. Also, a certified reference plasmid, ERM-AD623, was internationally accepted. This article mainly focuses on BCR-ABL1 measurement and these standardization efforts in progress.
断裂点簇集区-阿贝尔森（BCR-ABL1）易位是慢性髓性白血病（CML）的特征性标志。对CML患者而言，定量检测BCR-ABL1信使核糖核酸是必要的，而逆转录实时定量聚合酶链反应（RQ-PCR）是全球检测实验室中使用最广泛的方法。然而，由于缺乏标准化，不同实验室的RQ-PCR结果存在显著差异，使得实验室间的可比性令人难以信服。为便于实验室间的比较评估和国际标准化，提出了一种BCR-ABL1国际标准（IS）。从该国际标准得出的实验室特异性转换因子可在不改变程序的情况下将本地不同值转换为国际标准值。BCR-ABL1的标准化还包括整个分析过程，因此在进行BCR-ABL1定量分析之前关注质量控制值得注意。更重要的是，世界卫生组织已经验证了首个基因参考品系，该品系仅限于制造商生产和校准二级参考试剂。此外，一种经过认证的参考质粒ERM-AD623已被国际认可。本文主要关注BCR-ABL1的检测以及这些正在进行的标准化工作。
