QXDx BCR-ABL %IS 液滴数字 PCR 检测试剂盒性能评估
Performance Evaluation of the QXDx BCR-ABL %IS Droplet Digital PCR Assay.
机构信息
Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea.
Department of Laboratory Medicine, Seoul Clinical Laboratories, Yongin, Korea.
出版信息
Ann Lab Med. 2020 Jan;40(1):72-75. doi: 10.3343/alm.2020.40.1.72.
Accurate detection of fusion transcripts at and below molecular response (MR) 4 (0.01% International Scale [IS]) is required for disease monitoring in patients with chronic myeloid leukemia (CML). We evaluated the analytical performance of the QXDx BCR-ABL %IS (Bio-Rad, Hercules, CA, USA) droplet digital PCR (ddPCR) assay, which is the first commercially available ddPCR-based diagnostics product. In precision analysis, the %CV was 9.3% and 3.0%, with mean values of 0.031% IS and 9.4% IS, respectively. The assay was linear in the first order, ranging from 0.032% IS to 20% IS. The manufacturer-claimed limit of blank, limit of detection, and limit of quantification were verified successfully. There was a very strong correlation between the results of the QXDx BCR-ABL %IS ddPCR assay and the ipsogen BCR-ABL1 Mbcr IS-MMR (Qiagen, Hilden, Germany) real-time quantitative PCR assay (r=0.996). In conclusion, the QXDx BCR-ABL %IS ddPCR assay can provide reliable results for CML patients.
准确检测慢性髓性白血病 (CML) 患者在分子反应 (MR) 4 及以下水平（国际标准 [IS] 为 0.01%）的融合转录本，是疾病监测所必需的。我们评估了 QXDx BCR-ABL %IS（伯乐，美国加利福尼亚州赫拉克勒斯）液滴数字 PCR（ddPCR）检测的分析性能，这是首个市售的基于 ddPCR 的诊断产品。在精密度分析中，%CV 分别为 9.3%和 3.0%，平均值分别为 0.031%IS 和 9.4%IS。该检测呈一阶线性，范围从 0.032%IS 到 20%IS。制造商声称的空白限、检测限和定量限均得到成功验证。QDxDx BCR-ABL %IS ddPCR 检测与 ipsogen BCR-ABL1 Mbcr IS-MMR（凯杰，德国希尔德斯海姆）实时定量 PCR 检测的结果之间存在非常强的相关性（r=0.996）。总之，QDxDx BCR-ABL %IS ddPCR 检测可为 CML 患者提供可靠的结果。
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