title: Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA.
abstract: Serial quantitation of BCR-ABL mRNA levels is an important indicator of therapeutic response for patients with chronic myelogenous leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia, but there is substantial variation in the real-time quantitative polymerase chain reaction methodologies used by different testing laboratories. To help improve the comparability of results between centers we sought to develop accredited reference reagents that are directly linked to the BCR-ABL international scale. After assessment of candidate cell lines, a reference material panel comprising 4 different dilution levels of freeze-dried preparations of K562 cells diluted in HL60 cells was prepared. After performance evaluation, the materials were assigned fixed percent BCR-ABL/control gene values according to the International Scale. A recommendation that the 4 materials be established as the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL translocation by real-time quantitative polymerase chain reaction was approved by the Expert Committee on Biological Standardization of the World Health Organization in November 2009. We consider that the development of these reagents is a significant milestone in the standardization of this clinically important test, but because they are a limited resource we suggest that their availability is restricted to manufacturers of secondary reference materials.
authors: National Genetics Reference Laboratory Wessex, Salisbury District Hospital, Salisbury, UK.
authors: Helen E
authors: HE
authors: White
authors: Paul
authors: P
authors: Matejtschuk
authors: Peter
authors: P
authors: Rigsby
authors: Jean
authors: J
authors: Gabert
authors: Feng
authors: F
authors: Lin
authors: Y
authors: Y
authors: Lynn Wang
authors: Susan
authors: S
authors: Branford
authors: Martin C
authors: MC
authors: Müller
authors: Nathalie
authors: N
authors: Beaufils
authors: Emmanuel
authors: E
authors: Beillard
authors: Dolors
authors: D
authors: Colomer
authors: Dana
authors: D
authors: Dvorakova
authors: Hans
authors: H
authors: Ehrencrona
authors: Hyun-Gyung
authors: HG
authors: Goh
authors: Hakim
authors: H
authors: El Housni
authors: Dan
authors: D
authors: Jones
authors: Veli
authors: V
authors: Kairisto
authors: Suzanne
authors: S
authors: Kamel-Reid
authors: Dong-Wook
authors: DW
authors: Kim
authors: Stephen
authors: S
authors: Langabeer
authors: Edmond S K
authors: ES
authors: Ma
authors: Richard D
authors: RD
authors: Press
authors: Giuliana
authors: G
authors: Romeo
authors: Lihui
authors: L
authors: Wang
authors: Katerina
authors: K
authors: Zoi
authors: Timothy
authors: T
authors: Hughes
authors: Giuseppe
authors: G
authors: Saglio
authors: Andreas
authors: A
authors: Hochhaus
authors: John M
authors: JM
authors: Goldman
authors: Paul
authors: P
authors: Metcalfe
authors: Nicholas C P
authors: NC
authors: Cross
mesh_terms: D002460:Cell Line; D016044:Fusion Proteins, bcr-abl / Q000235:genetics*; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000235:genetics*; D012333:RNA, Messenger / Q000235:genetics*; D012015:Reference Standards; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods / Q000592:standards*; D014944:World Health Organization
chemical_list: D012333:RNA, Messenger; D016044:Fusion Proteins, bcr-abl