title: Comparative study of BCR-ABL1 quantification: Xpert assay, a feasible solution to standardization concerns.
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.
authors.affiliation: Hematology Department, Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, Spain.
authors.forename: C E
authors.initials: CE
authors.lastname: López-Jorge
authors.forename: M T
authors.initials: MT
authors.lastname: Gómez-Casares
authors.forename: A
authors.initials: A
authors.lastname: Jiménez-Velasco
authors.forename: M A
authors.initials: MA
authors.lastname: García-Bello
authors.forename: M
authors.initials: M
authors.lastname: Barrios
authors.forename: J
authors.initials: J
authors.lastname: Lopez
authors.forename: S
authors.initials: S
authors.lastname: de la Iglesia
authors.forename: T
authors.initials: T
authors.lastname: Ramírez
authors.forename: G
authors.initials: G
authors.lastname: Sánchez
authors.forename: A I
authors.initials: AI
authors.lastname: Heiniger
authors.forename: T
authors.initials: T
authors.lastname: Molero
mesh_terms: D057205:Automation, Laboratory; D014408:Biomarkers, Tumor / Q000032:analysis / Q000235:genetics; D004252:DNA Mutational Analysis / Q000295:instrumentation / Q000379:methods* / Q000592:standards*; D005240:Feasibility Studies; D016044:Fusion Proteins, bcr-abl / Q000032:analysis* / Q000235:genetics; D018628:Gene Dosage; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000175:diagnosis / Q000235:genetics; D060888:Real-Time Polymerase Chain Reaction / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D012015:Reference Standards
chemical_list: D014408:Biomarkers, Tumor; D016044:Fusion Proteins, bcr-abl