title: Evaluation of clinical performance of the major BCR-ABL mRNA detection kit which enables conversion to international standard scale using the reference material calibrator.
abstract: In a multicenter study, we evaluated the Major BCR-ABL mRNA/ABL mRNA quantification kit (M135R), which uses reference material included in the kit designed to report results using the international scale (IS). In total, 127 samples were studied. A good correlation was observed between M135R results and home-brew RT-qPCR results, which are reported on the IS using a conversion factor (r=0.90; n=115). However, the correlation coefficient between M135R results and Amp-CML results was relatively low (r=0.56; n=108). A good correlation was observed between M135R results from the two assay sites (r=0.94; n=115). The subset analysis of samples from the two assay sites showed M135R to have a good correlation even in the low IS range (r=0.98; IS≤1%). M135R showed high sensitivity and accuracy for detecting minimal residual disease and is considered to be a useful tool for treatment response assessment and for early detection of recurrence in CML patients.
authors.affiliation: Department of Hematology, Japanese Red Cross Nagoya First Hospital.
authors.forename: Koichi
authors.initials: K
authors.lastname: Miyamura
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Okamoto
authors.forename: Noriko
authors.initials: N
authors.lastname: Usui
authors.forename: Masayuki
authors.initials: M
authors.lastname: Hino
authors.forename: Koichi
authors.initials: K
authors.lastname: Akashi
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Nakaseko
authors.forename: Naoto
authors.initials: N
authors.lastname: Takahashi
authors.forename: Kaname
authors.initials: K
authors.lastname: Nakatani
authors.forename: Keita
authors.initials: K
authors.lastname: Takahashi
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Nobori
authors.forename: Tomoki
authors.initials: T
authors.lastname: Naoe
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002138:Calibration; D005260:Female; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000175:diagnosis* / Q000188:drug therapy / Q000235:genetics; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000188:drug therapy; D012333:RNA, Messenger / Q000032:analysis* / Q000235:genetics; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods; D015398:Signal Transduction / Q000502:physiology; D055815:Young Adult
chemical_list: D012333:RNA, Messenger