Comparative study of BCR-ABL1 quantification: Xpert assay, a feasible solution to standardization concerns

Ann Hematol. 2012 Aug;91(8):1245-50. doi: 10.1007/s00277-012-1468-4. Epub 2012 Apr 25.

Abstract

The level of BCR-ABL1 reached after treatment with tyrosine kinase inhibitors is an effective marker of the therapeutic response and a good survival predictor in chronic myeloid leukemia (CML) patients. However, no agreement has yet been achieved about either the standardization of the technique to determine BCR-ABL1 or the interpretation of the results. The aim of this study was to compare the method currently recommended by the European Leukemia Net, which includes the application of a conversion factor to express the results in international scale, with an automated method (Xpert BCR-ABL™, Cepheid). BCR-ABL1 transcript quantification was performed in 117 samples from CML patients in two different laboratories by both methods, and the results were compared by statistical procedures. A high linear correlation was obtained in the results between the two methods. The concordance at logarithmic intervals reached 62 %. When the major molecular response (MMR) was analyzed, 85 % agreement was achieved. The automated method provides reproducible results and does not show significant differences compared with the traditional method. As a clinical tool, Xpert correctly classified the patients in MMR and can be considered a useful alternative for the molecular follow-up of CML patients.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Automation, Laboratory
  • Biomarkers, Tumor / analysis
  • Biomarkers, Tumor / genetics
  • DNA Mutational Analysis / instrumentation
  • DNA Mutational Analysis / methods*
  • DNA Mutational Analysis / standards*
  • Feasibility Studies
  • Fusion Proteins, bcr-abl / analysis*
  • Fusion Proteins, bcr-abl / genetics
  • Gene Dosage
  • Humans
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive / diagnosis
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive / genetics
  • Real-Time Polymerase Chain Reaction / instrumentation
  • Real-Time Polymerase Chain Reaction / methods
  • Real-Time Polymerase Chain Reaction / standards*
  • Reference Standards

Substances

  • Biomarkers, Tumor
  • Fusion Proteins, bcr-abl