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Title: A novel approach for BCR-ABL1 standardization to improve International Scale estimation
Authors: MAES, Brigitte 
Bakkus, M.
Boeckx, N.
Boone, Els
Cauwelier, B.
Denys, B.
De Schouwer, P.
Devos, T.
El Housni, H.
Hillen, F.
Jacobs, K.
Lambert, F.
Louagie, H.
Maes, M.
Meeus, M.-B.
Moreau, E.
Nollet, F.
Peeters, K.
Saussoy, P.
Van Lint, P.
Vaerman, J.-L.
Vaeyens, F.
Vandepoele, K.
Vannuffel, P.
Ver Elst, K.
Vermeulen, K.
Issue Date: 2016
Source: International Journal of Laboratory Hematology, 38(6), p. 674-684
Abstract: Introduction: Standardization of BCR-ABL1 messenger RNA quantifi-cation 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.R esults 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 pro-posed method is a valuable alternative.
Notes: Maes, B (reprint author), Jessa Hosp, Lab Mol Diagnost, Salvatorstr 20, B-3500 Hasselt, Belgium.
Keywords: chronic myelogenous leukaemia; BCR-ABL1; standardization; international scale; therapymonitoring
Document URI:
ISSN: 1751-5521
e-ISSN: 1751-553X
DOI: 10.1111/ijlh.12556
ISI #: 000393891800013
Rights: © 2016 John Wiley & Sons Ltd.
Category: A1
Type: Journal Contribution
Validations: ecoom 2018
Appears in Collections:Research publications

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