Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
Department of Hematology, Nippon Medical School, Tokyo, Japan.
Jpn J Clin Oncol. 2024 Feb 7;54(2):153-159. doi: 10.1093/jjco/hyad156.
Minimal residual disease assessment of BCR-ABL messenger ribonucleic acid levels is crucial in Philadelphia chromosome-positive acute lymphoblastic leukemia for prognosis and treatment planning. However, accurately quantifying minor BCR-ABL transcripts, which comprise 70% of Philadelphia chromosome-positive acute lymphoblastic leukemia cases, lacks a national-approved method.
We developed the "Otsuka" minor BCR-ABLmessenger ribonucleic acid assay kit with exceptional precision (0.00151%). Minor BCR-ABL messenger ribonucleic acid levels were analyzed in 175 adults, 36 children with acute lymphoblastic leukemia and 25 healthy individuals to evaluate the kit's performance.
The "Otsuka" kit showed high concordance with a commonly used chimeric gene screening method, indicating reliable detection of positive cases. Quantitative results demonstrated a robust correlation with both a laboratory-developed test and a diagnostic research product. The "Otsuka" kit performs comparably or even surpass to conventional products, providing valuable insights into Philadelphia chromosome-positive acute lymphoblastic leukemia pathology.
The 'Otsuka" minor BCR-ABL messenger ribonucleic acid assay kit exhibits excellent performance in quantifying minor BCR-ABL transcripts in Philadelphia chromosome-positive acute lymphoblastic leukemia patients. Our results align well with established screening methods and show a strong correlation with laboratory-developed tests and diagnostic research products. The "Otsuka" kit holds great promise as a valuable tool for understanding Philadelphia chromosome-positive acute lymphoblastic leukemia pathology and guiding effective treatment strategies.
微小残留病 BCR-ABL 信使核糖核酸水平评估对于费城染色体阳性急性淋巴细胞白血病的预后和治疗计划至关重要。然而，准确量化由 70%费城染色体阳性急性淋巴细胞白血病病例组成的次要 BCR-ABL 转录本缺乏国家批准的方法。
我们开发了“大冢”微小 BCR-ABL 信使核糖核酸检测试剂盒，具有卓越的精度（0.00151%）。分析了 175 名成年人、36 名儿童急性淋巴细胞白血病和 25 名健康个体的微小 BCR-ABL 信使核糖核酸水平，以评估试剂盒的性能。
“大冢”试剂盒与常用的嵌合基因筛查方法具有高度一致性，表明能够可靠地检测阳性病例。定量结果与实验室开发的检测方法和诊断研究产品具有强大的相关性。“大冢”试剂盒的性能与传统产品相当甚至更好，为费城染色体阳性急性淋巴细胞白血病的病理提供了有价值的见解。
“大冢”微小 BCR-ABL 信使核糖核酸检测试剂盒在定量费城染色体阳性急性淋巴细胞白血病患者的微小 BCR-ABL 转录本方面表现出优异的性能。我们的结果与既定的筛查方法一致，并与实验室开发的检测方法和诊断研究产品具有很强的相关性。“大冢”试剂盒有望成为理解费城染色体阳性急性淋巴细胞白血病病理和指导有效治疗策略的有价值工具。
