慢性粒细胞白血病 (CML) 的特征是费城染色体，导致 BCR::ABL1 融合基因和粒细胞过度增殖。酪氨酸激酶抑制剂 (TKI) 有效，而微小残留病 (MRD) 监测至关重要。与定量 PCR 相比，数字 PCR 平台的精度更高，但缺乏比较研究。使用数字微滴 PCR (ddPCR)（QXDx™ BCR-ABL %IS 试剂盒）和芯片数字 PCR (cdPCR)（Dr. PCR™ BCR-ABL1 主要 IS 检测试剂盒）。总体而言，定性和定量一致性良好。敏感性分析显示阳性一致性百分比和阴性一致性百分比均≥90%，分子反应（MR）水平分类的二次加权kappa指数为0.94（95%CI 0.89，0.98）。 MR 水平亚组分析显示 MR3 或以上的 MR 水平在分类上完全一致，而 MR4 或以下的患者样本中有 35.4% (17/48) 显示出不一致的分类。总体而言，%BCR::ABL1/ABL1 转换为国际量表 (BCR::ABL1 IS) 的比率的 Lin 一致性相关系数 (CCC) 几乎是完美的定量一致性（Lin 的 CCC=0.99）。按 MR 水平的亚组，Lin 的 CCC 显示随着 MR 加深，BCR::ABL1 IS 降低的定量一致性。cdPCR 和 ddPCR 在检测 BCR::ABL1 转录本方面表现出相当的性能，在 MR3 或更高水平上具有高度一致性。在平台之间进行选择可能取决于成本、工作流程和敏感性要求。© 2024 作者，由柏林/波士顿 De Gruyter 出版。

Chronic myeloid leukemia (CML) is characterized by the Philadelphia chromosome, leading to the BCR::ABL1 fusion gene and hyper-proliferation of granulocytes. Tyrosine kinase inhibitors (TKIs) are effective, and minimal residual disease (MRD) monitoring is crucial. Digital PCR platforms offer increased precision compared to quantitative PCR but lack comparative studies.Eighty CML patient samples were analyzed in parallel using digital droplet PCR (ddPCR) (QXDx™ BCR-ABL %IS Kit) and chip digital PCR (cdPCR) (Dr. PCR™ BCR-ABL1 Major IS Detection Kit).Overall, qualitative and quantitative agreement was good. Sensitivity analysis showed positive percentage agreement and negative percentage agreement were both ≥90 %, and the quadratic weighted kappa index for molecular response (MR) level categorization was 0.94 (95 %CI 0.89, 0.98). MR levels subgroup analysis showed perfect categorical agreement on MR level at MR3 or above, while 35.4 % (17/48) of patient samples with MR4 or below showed discordant categorizations. Overall, Lin's concordance correlation coefficient (CCC) for the ratio of %BCR::ABL1/ABL1 converted to the International Scale (BCR::ABL1 IS) was almost perfect quantitative agreement (Lin's CCC=0.99). By subgroups of MR levels, Lin's CCC showed a quantitative agreement of BCR::ABL1 IS decreased as MR deepened.Both cdPCR and ddPCR demonstrated comparable performance in detecting BCR::ABL1 transcripts with high concordance in MR3 level or above. Choosing between platforms may depend on cost, workflow, and sensitivity requirements.© 2024 the author(s), published by De Gruyter, Berlin/Boston.