期刊
ANNALS OF LABORATORY MEDICINE
卷 40, 期 1, 页码 72-75出版社
KOREAN SOC LABORATORY MEDICINE
DOI: 10.3343/alm.2020.40.1.72
关键词
BCR-ABL; Droplet digital PCR; Performance; Evaluation; Chronic myeloid leukemia
资金
- Konkuk University Medical Center
Accurate detection of BCR-ABL 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 in vitro 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.
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