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

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

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.

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

Publication types

  • Evaluation Study

MeSH terms

  • 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

Substances

  • DNA, Neoplasm
  • Reagent Kits, Diagnostic
  • Fusion Proteins, bcr-abl