title: [Guidelines for molecular monitoring of BCR-ABL1 in chronic myeloid leukemia patients by RT-qPCR].
abstract: Current clinical guidelines for managing chronic myeloid leukemia include molecular monitoring of BCR-ABL1 transcript quantitative reverse-transcription PCR. Despite the proven prognostic significance of molecular response, it is not widely appreciated that quantitative reverse-transcription PCR potentially produces highly variable data, which may affect the validity of results, making comparability between different laboratories difficult. Therefore, standardized reporting of BCR-ABL1 measurements is needed for optimal clinical management. An approach to achieve comparable BCR-ABL1 values is the use of an international reporting scale. Conversion to the international scale is achieved by the application of laboratory specific conversion factor that is obtained by using validated secondary reference calibrators. Moreover, with the aim to mitigate the interlaboratory imprecision of quantitative BCR-ABL1 measurements and to facilitate local laboratory results interpretation and reporting, we decide to prepare laboratory guidelines that will further facilitate interlaboratory comparative studies and independent quality-assessment programs, which are of paramount importance for worldwide standardization of BCR-ABL1 monitoring results, in particular for those most isolated laboratories, with not easy access to commercial kits or sample interchange programs.
authors.affiliation: Instituto de Medicina Experimental (IMEX-CONICET), Academia Nacional de Medicina, Buenos Aires, Argentina.
authors.forename: Irene
authors.initials: I
authors.lastname: Larripa
authors.affiliation: Centro de investigaciones Oncológicas, Fundación Cáncer (CIO-FUCA), Instituto Alexander Fleming, Argentina.
authors.forename: María Sol
authors.initials: MS
authors.lastname: Ruiz
authors.affiliation: Stamboulian, Buenos Aires, Argentina.
authors.forename: Marina
authors.initials: M
authors.lastname: Gutiérrez
authors.affiliation: Centro de investigaciones Oncológicas, Fundación Cáncer (CIO-FUCA), Instituto Alexander Fleming, Argentina. E-mail: mbianchini@conicet.gov.ar.
authors.forename: Michele
authors.initials: M
authors.lastname: Bianchini
mesh_terms: D014408:Biomarkers, Tumor / Q000097:blood* / Q000235:genetics; D016044:Fusion Proteins, bcr-abl / Q000097:blood*; D016313:Genes, abl / Q000235:genetics*; D017408:Guidelines as Topic; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000097:blood* / Q000188:drug therapy / Q000235:genetics; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D012015:Reference Standards; D020133:Reverse Transcriptase Polymerase Chain Reaction
chemical_list: C581634:BCR-ABL1 fusion protein, human; D014408:Biomarkers, Tumor; D047428:Protein Kinase Inhibitors; D016044:Fusion Proteins, bcr-abl
keywords: chronic myeloid leukemia; molecular monitoring; standardization