title: A new diagnostic kit, ODK-1201, for the quantitation of low major BCR-ABL mRNA level in chronic myeloid leukemia: correlation of quantitation with major BCR-ABL mRNA kits.
abstract: The current first-line therapy of chronic myeloid leukemia (CML) is based on tyrosine kinase inhibitors. Diagnostic kits that are capable of identifying at least a 4.5 log reduction in the international scale % BCR-ABL/ABL (IS % BCR-ABL/ABL) are needed for use in the clinical evaluation of deeper molecular response to treatment and to determine the timing of dose selection or treatment interruption during the course of treatment. In this study, we evaluated the performance of a new diagnostic kit, ODK-1201, designed to be capable of performing reverse transcription and quantitative PCR in a single tube for the quantitation of major BCR-ABL mRNA. The kit demonstrated excellent assay performance (limit of detection 0.0007 %) and a broader detection range of BCR-ABL mRNA in peripheral blood compared to a commercially available kit for CML (Amp-CML). ODK-1201 was also shown to be as sensitive as Ipsogen and Molecular MD kits in the same assay. Results obtained in this study indicate evidences that ODK-1201 was capable of identifying at least a 4.5 log reduction in the IS % BCR-ABL/ABL.
authors.affiliation: Hematology, Graduate School of Medicine, Osaka City University, 1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan, hirohisa@msic.med.osaka-cu.ac.jp.
authors.forename: Hirohisa
authors.initials: H
authors.lastname: Nakamae
authors.forename: Chikashi
authors.initials: C
authors.lastname: Yoshida
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Miyata
authors.forename: Michihiro
authors.initials: M
authors.lastname: Hidaka
authors.forename: Naokuni
authors.initials: N
authors.lastname: Uike
authors.forename: Daisuke
authors.initials: D
authors.lastname: Koga
authors.forename: Takayuki
authors.initials: T
authors.lastname: Sogabe
authors.forename: Itaru
authors.initials: I
authors.lastname: Matsumura
authors.forename: Yuzuru
authors.initials: Y
authors.lastname: Kanakura
authors.forename: Tomoki
authors.initials: T
authors.lastname: Naoe
mesh_terms: D005260:Female; D016044:Fusion Proteins, bcr-abl / Q000097:blood*; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000097:blood* / Q000628:therapy; D008297:Male; D018365:Neoplasm, Residual / Q000097:blood; D012333:RNA, Messenger / Q000097:blood*; D012334:RNA, Neoplasm / Q000097:blood*; D011933:Reagent Kits, Diagnostic
chemical_list: D012333:RNA, Messenger; D012334:RNA, Neoplasm; D011933:Reagent Kits, Diagnostic; D016044:Fusion Proteins, bcr-abl