title: Reconsideration of BCR-ABL protein flow cytometric immunobead assay: how potent to diagnose and monitor chronic myeloid leukemia?
abstract: BACKGROUND
  Chronic myeloid leukemia (CML) is typically associated with the Philadelphia chromosome, resulting in the production of BCR-ABL fusion oncoprotein with upregulated tyrosine kinase activity. We aimed to evaluate a new flow cytometric immunobead assay to detect BCR-ABL protein in a group of patients with CML.
  
  
  METHODS
  We enrolled 49 patients with CML, whose qRT-PCR and/or cytogenetic analysis of Philadelphia chromosome aberration was available, including tyrosine kinase inhibitors (TKIs)-naïve and (TKIs)-treated patients with various levels of response. Twenty Philadelphia-negative healthy individuals were also enrolled to obtain analytical negative controls. Peripheral blood samples were analyzed for BCR-ABL fusion protein by flow cytometry.
  
  
  RESULTS
  The BCR-ABL fusion protein flow cytometric assay seemed efficacious to both diagnose the presence (P-value <0.0001) and distinguish the levels (P-value = 0) of the Philadelphia chromosome aberration. Groups of TKI-naïve and TKI-treated patients as well as levels of molecular/cytogenetic response to TKI-therapy were effectively discriminated (P-value <0.01). The receiver operating characteristic (ROC) curve analysis indicated the diagnostic value of the assay as excellent (AUC = 0.95, P-value = 0).
  
  
  CONCLUSIONS
  The evaluated BCR-ABL fusion protein assay might be useful for diagnosing and monitoring Philadelphia chromosome aberration.
authors.affiliation: Department of Biochemistry and Microbiology, Faculty of Pharmacy, Damascus University, Damascus, Syria.
authors.forename: R
authors.initials: R
authors.lastname: Kelani
authors.affiliation: Department of Biochemistry and Microbiology, Faculty of Pharmacy, Damascus University, Damascus, Syria.|Clinical Laboratories Department, AL-Assad Hospital, Damascus University, Damascus, Syria.
authors.forename: F
authors.initials: F
authors.lastname: Monem
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D002648:Child; D005260:Female; D005434:Flow Cytometry / Q000379:methods*; D016044:Fusion Proteins, bcr-abl / Q000235:genetics / Q000378:metabolism*; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000175:diagnosis* / Q000188:drug therapy / Q000235:genetics / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D012372:ROC Curve; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D016044:Fusion Proteins, bcr-abl
keywords: BCR-ABL fusion protein; Philadelphia chromosome; chronic myeloid leukemia; flow cytometry; tyrosine kinase inhibitors