title: Evaluation of a novel multiplex RT-qPCR assay for the quantification of leukemia-associated BCR-ABL1 translocation.
abstract: Although monitoring of BCR-ABL1 translocation has become an established practice in the management of chronic myeloid leukemia (CML), the detection limit of the BCR-ABL1 transcripts needs more standardization. The aim of the present study was to evaluate the clinical performances of a novel assay for the quantification of BCR-ABL1 fusion transcripts (e13a2 and e14a2) and ABL1 in a single reaction. This assay is based on the real-time reverse transcription polymerase chain reaction (RT-qPCR) in multiplex format. In a retrospective comparative clinical study performed in a reference laboratory, RNA was extracted from 48 CML patient blood samples with various BCR-ABL1/ABL1 ratios and RT-qPCR was performed using either MAScIR assay or the RT-qPCR simplex reference assay used in routine clinical testing. The comparative clinical results showed high qualitative and quantitative concordance (correlation coefficient >0.95) between MAScIR and the reference assays. The present study illustrates the utility of MAScIR assay as a sensitive, rapid, and cost-effective quantitative device to monitor the BCR-ABL1 ratios by RT-qPCR on whole blood of diagnosed Philadelphia chromosome-positive (Ph+) leukemia patients. This test could be used as an aid in the assessment of molecular response to available treatments.
authors.affiliation: MAScIR: Moroccan Foundation for Advanced Sciences, Innovation and Research, Medical Biotechnology Center, Rabat Design, Rue Mohamed El Jazouli, Madinat Al Irfane, 10100, Rabat, Morocco.
authors.forename: D
authors.initials: D
authors.lastname: Kottwitz
authors.forename: H
authors.initials: H
authors.lastname: El Hadi
authors.forename: M
authors.initials: M
authors.lastname: El Amrani
authors.forename: S
authors.initials: S
authors.lastname: Cabezas
authors.forename: H
authors.initials: H
authors.lastname: Dehbi
authors.forename: S
authors.initials: S
authors.lastname: Nadifi
authors.forename: A
authors.initials: A
authors.lastname: Quessar
authors.forename: D
authors.initials: D
authors.lastname: Colomer
authors.forename: Abdeladim
authors.initials: A
authors.lastname: Moumen
authors.forename: E L Hassan
authors.initials: EL
authors.lastname: Sefrioui
mesh_terms: D005260:Female; D016044:Fusion Proteins, bcr-abl / Q000097:blood* / Q000235:genetics; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000097:blood* / Q000235:genetics; D008297:Male; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D010677:Philadelphia Chromosome; D012333:RNA, Messenger / Q000097:blood* / Q000235:genetics; D012189:Retrospective Studies; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods*; D014178:Translocation, Genetic
chemical_list: C581634:BCR-ABL1 fusion protein, human; D012333:RNA, Messenger; D016044:Fusion Proteins, bcr-abl