Ann Lab Med.  2020 Jan;40(1):72-75. 10.3343/alm.2020.40.1.72.

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

Affiliations
  • 1Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea. dearmina@hanmail.net
  • 2Department of Laboratory Medicine, Seoul Clinical Laboratories, Yongin, Korea.

Abstract

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.

Keyword

BCR-ABL; Droplet digital PCR; Performance; Evaluation; Chronic myeloid leukemia
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