Performance Evaluation of the QXDx BCR-ABL %IS Droplet Digital PCR Assay

• Published in: Annals of laboratory medicine Vol. 40; no. 1; pp. 72 - 75
• Main Authors: Chung, Hee-Jung, Hur, Mina, Yoon, Sumi, Hwang, Keumrock, Lim, Hwan-Sub, Kim, Hanah, Moon, Hee-Won, Yun, Yeo-Min
• Format: Journal Article
• Language: English
• Published: Korea (South) The Korean Society for Laboratory Medicine 01.01.2020; 대한진단검사의학회
• Subjects: Brief Communication; DNA, Neoplasm - genetics; DNA, Neoplasm - metabolism; Fusion Proteins, bcr-abl - genetics; Humans; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - diagnosis; Limit of Detection; Polymerase Chain Reaction - methods; Reagent Kits, Diagnostic; 병리학; Evaluation; Droplet digital PCR; Chronic myeloid leukemia; Performance; BCR-ABL
• ISSN: 2234-3806; 2234-3814; 2234-3814
• 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.