title: Harmonization of molecular monitoring of chronic myeloid leukemia therapy in Japan.
abstract: BACKGROUND
  Real-time quantitative polymerase chain reaction (RQ-PCR) has been widely used for molecular monitoring for patients with chronic myeloid leukemia (CML). Currently, RQ-PCR is not based on the concept of international scale (IS) in Japan; mainly because none of the domestic laboratories have obtained their own conversion factor (CF) which makes it possible to convert locally scaled BCR-ABL (BCR-ABL (L)) value to the IS (BCR-ABL (IS)). To join the global trend of molecular assessment of BCR-ABL in CML patients, we have tried to obtain a CF in Japan.
  
  
  METHODS
  Samples from 55 patients were exchanged between the Japanese laboratory and the reference laboratory in Adelaide, and BCR-ABL and internal control gene transcripts of the samples were measured using RQ-PCR. The patient bias conversion method was used to determine the CF for the IS using the Bland and Altman method.
  
  
  RESULTS
  The local CF in the Japanese laboratory was determined to be 0.87. Based on this CF, 0.1% BCR-ABL (IS), defined as major molecular response, becomes equivalent to 731 copy/μg RNA BCR-ABL (L).
  
  
  CONCLUSIONS
  This study is the first to introduce a laboratory-specific CF for harmonizing RQ-PCR methodology for detecting BCR-ABL transcripts to Japan, which may open new windows for molecular assessment of CML patients in Japan.
authors: Department of Hematology, National Hospital Organization Mito Medical Center, 280 Sakuranosato, Ibarakimachi, Higashiibarakigun, Ibaraki, 311-3193, Japan. c.yoshida.d@mn.hosp.go.jp
authors: Chikashi
authors: C
authors: Yoshida
authors: Linda
authors: L
authors: Fletcher
authors: Kazuteru
authors: K
authors: Ohashi
authors: Hisashi
authors: H
authors: Wakita
authors: Takashi
authors: T
authors: Kumagai
authors: Masayuki
authors: M
authors: Shiseki
authors: Kousei
authors: K
authors: Matsuei
authors: Koiti
authors: K
authors: Inokuchi
authors: Yoshihiro
authors: Y
authors: Hatta
authors: Yukari
authors: Y
authors: Shirasugi
authors: Toshikazu
authors: T
authors: Yamaguchi
authors: Junichi
authors: J
authors: Sakamoto
authors: Susan
authors: S
authors: Branford
authors: Hisashi
authors: H
authors: Sakamaki
mesh_terms: D016044:Fusion Proteins, bcr-abl / Q000032:analysis / Q000235:genetics; D006801:Humans; D007564:Japan; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000175:diagnosis / Q000235:genetics* / Q000628:therapy*; D012333:RNA, Messenger / Q000032:analysis; D060888:Real-Time Polymerase Chain Reaction; D020133:Reverse Transcriptase Polymerase Chain Reaction
chemical_list: D012333:RNA, Messenger; D016044:Fusion Proteins, bcr-abl