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A novel approach for BCR ‐ ABL 1 standardization to improve International Scale estimation
Author(s) -
Maes B.,
Bakkus M.,
Boeckx N.,
Boone E.,
Cauwelier B.,
Denys B.,
De Schouwer P.,
Devos T.,
El Housni H.,
Hillen F.,
Jacobs K.,
Lambert F.,
Louagie H.,
Maes M.B.,
Meeus P.,
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.,
Bruyndonckx R.
Publication year - 2016
Publication title -
international journal of laboratory hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.705
H-Index - 55
eISSN - 1751-553X
pISSN - 1751-5521
DOI - 10.1111/ijlh.12556
Subject(s) - standardization , computer science , breakpoint cluster region , external quality assessment , process (computing) , scale (ratio) , medicine , engineering , operations management , physics , receptor , quantum mechanics , operating system
Summary Introduction Standardization of BCR ‐ ABL 1 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 ‐ ABL 1 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 ‐ ABL 1 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 ‐ ABL 1 measurements to improve IS estimation. In expectation of a true golden standard method for BCR ‐ ABL 1 IS quantification, the proposed method is a valuable alternative.