title: A review of the challenge in measuring and standardizing BCR-ABL1.
abstract: Breakpoint cluster region-Abelson (BCR-ABL1) translocation is the characteristic sign of chronic myeloid leukemia (CML). The quantitation of BCR-ABL1 messenger RNA is requisite for patients with CML, and reverse-transcription real-time quantitative polymerase chain reaction (RQ-PCR) is the method used most extensively in testing laboratories worldwide. Nevertheless, substantial variation in RQ-PCR results from different laboratories makes interlaboratory comparability inconvincible owing to the lack of standardization. To facilitate interlaboratory comparative assessment and international standardization, an international scale (IS) for BCR-ABL1 was proposed. The laboratory-specific conversion factors derived from the IS can convert local different values to the IS without changing procedures. The standardization of BCR-ABL1 also includes the whole analytical process, so it is noteworthy to pay attention to the quality control before BCR-ABL1 quantitative analysis. More importantly, the World Health Organization has validated a first genetic reference panel which is limited to the manufacturers to produce and calibrate secondary reference reagents. Also, a certified reference plasmid, ERM-AD623, was internationally accepted. This article mainly focuses on BCR-ABL1 measurement and these standardization efforts in progress.
authors.affiliation: .
authors.forename: Shuping
authors.initials: S
authors.lastname: Yu
authors.affiliation: .
authors.forename: Ming
authors.initials: M
authors.lastname: Cui
authors.affiliation: .
authors.forename: Xiao
authors.initials: X
authors.lastname: He
authors.affiliation: .
authors.forename: Rongrong
authors.initials: R
authors.lastname: Jing
authors.affiliation: .
authors.forename: Huimin
authors.initials: H
authors.lastname: Wang
mesh_terms: D020732:Cytogenetic Analysis / Q000592:standards; D016044:Fusion Proteins, bcr-abl / Q000032:analysis* / Q000235:genetics / Q000592:standards; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000175:diagnosis*; D010957:Plasmids / Q000235:genetics / Q000378:metabolism; D011786:Quality Control; D060888:Real-Time Polymerase Chain Reaction / Q000592:standards; D012015:Reference Standards
chemical_list: D016044:Fusion Proteins, bcr-abl
keywords: BCR-ABL1 measurement; BCR-ABL1 monitoring; standardization