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

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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.

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Acknowledgments

This study was supported by grants from Beca “Carmen Lavigne’ AECC 2010 and Fondo de Investigación Sanitaria (FIS, Spain) PI-07/0608.

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Correspondence to M. T. Gómez-Casares.

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López-Jorge, C.E., Gómez-Casares, M.T., Jiménez-Velasco, A. et al. Comparative study of BCR-ABL1 quantification: Xpert assay, a feasible solution to standardization concerns. Ann Hematol 91, 1245–1250 (2012). https://doi.org/10.1007/s00277-012-1468-4

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  • DOI: https://doi.org/10.1007/s00277-012-1468-4

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