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A novel approach for BCR-ABL1 standardization to improve International Scale estimation

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Maes, B Bakkus, M Boeckx, N Boone, E Cauwelier, B Saussoy, Pascale [UCL] Vaerman, Jean-Luc [UCL] Belgian working group on BCR-ABL1 IS standardization

INTRODUCTION: Standardization of BCR-ABL1 messenger RNA quantification by real-time PCR on the International Scale (IS) is critical for monitoring therapy response in chronic myelogenous leukaemia. Since 2006, BCR-ABL1 IS standardization is propagated along reference laboratories by calculating a laboratory-specific conversion factor (CF), co-ordinated in Europe through the European Treatment and Outcome Study project. Although this process has proven successful to some extent, it has not been achievable for all laboratories due to the complexity of the process and the stringent requirements in terms of numbers of samples to be exchanged. In addition, several BCR-ABL1 IS quantification methods and secondary reference materials became commercially available. However, it was observed that different IS methods generate consistently different results. METHODS: To overcome these difficulties, we have developed an alternative and simple approach of CF calculation, based on the retrospective analysis of existing external quality assessment (EQA) data. Our approach does not depend on the exchange of samples and is solely based on the mathematical CF calculation using EQA results. RESULTS AND CONCLUSION: We have demonstrated by thorough statistical validation that this approach performs well in converting BCR-ABL1 measurements to improve IS estimation. In expectation of a true golden standard method for BCR-ABL1 IS quantification, the proposed method is a valuable alternative.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès restreint
Publication date 2016
Language Anglais
Journal information "International Journal of Laboratory Hematology" - Vol. 38, no.6, p. 674-684 (2016)
Peer reviewed yes
Publisher Blackwell Publishing Limited ((United Kingdom) Oxford)
issn 1751-5521
e-issn 1751-553X
Publication status Publié
Affiliations UCL - SSS/IREC/SLUC - Pôle St.-Luc
UCL - (SLuc) Centre de thérapie tissulaire et cellulaire
UCL - (SLuc) Service de biologie hématologique
MESH Subject Fusion Proteins, bcr-abl ; Genetic Testing ; International Cooperation ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive ; Methods ; Observer Variation ; RNA, Messenger ; Reference Standards ; Retrospective Studies
Keywords BCR-ABL1 ; Chronic myelogenous leukaemia ; International Scale ; Standardization ; Therapy monitoring
Links
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Bibliographic reference Maes, B ; Bakkus, M ; Boeckx, N ; Boone, E ; Cauwelier, B ; et. al. A novel approach for BCR-ABL1 standardization to improve International Scale estimation. In: International Journal of Laboratory Hematology, Vol. 38, no.6, p. 674-684 (2016)
Permanent URL http://hdl.handle.net/2078.1/184144