@article{3085790,
    title = "Development and evaluation of a secondary reference panel for BCR-ABL1 quantification on the International Scale",
    author = "Cross, N.C.P. and White, H.E. and Ernst, T. and Welden, L. and Dietz, C. and Saglio, G. and Mahon, F.-X. and Wong, C.C. and Zheng, D. and Wong, S. and Wang, S.-S. and Akiki, S. and Albano, F. and Andrikovics, H. and Anwar, J. and Balatzenko, G. and Bendit, I. and Beveridge, J. and Boeckx, N. and Cerveira, N. and Cheng, S.-M. and Colomer, D. and Czurda, S. and Daraio, F. and Dulucq, S. and Eggen, L. and El Housni, H. and Gerrard, G. and Gniot, M. and Izzo, B. and Jacquin, D. and Janssen, J.J.W.M. and Jeromin, S. and Jurcek, T. and Kim, D.-W. and Machova-Polakova, K. and Martinez-Lopez, J. and McBean, M. and Mesanovic, S. and Mitterbauer-Hohendanner, G. and Mobtaker, H. and Mozziconacci, M.-J. and Pajič, T. and Pallisgaard, N. and Panagiotidis, P. and Press, R.D. and Qin, Y.-Z. and Radich, J. and Sacha, T. and Touloumenidou, T. and Waits, P. and Wilkinson, E. and Zadro, R. and Müller, M.C. and Hochhaus, A. and Branford, S.",
    journal = "Leukemia Research",
    year = "2016",
    volume = "30",
    number = "9",
    pages = "1844-1852",
    publisher = "Nature Publishing Group",
    issn = "0145-2126",
    doi = "10.1038/leu.2016.90",
    keywords = "BCR ABL protein;  BCR ABL protein;  BCR protein, human;  breakpoint cluster region protein, ABL1 gene;  accuracy;  Article;  BCR gene;  controlled study;  evaluation study;  gene;  GUSB gene;  human;  human cell;  polymerase chain reaction;  priority journal;  quality control;  quantitative analysis;  reference value;  reverse transcription;  sensitivity analysis;  calibration;  genetics;  oncogene;  standard;  standards;  world health organization, Calibration;  Fusion Proteins, bcr-abl;  Genes, abl;  Humans;  Polymerase Chain Reaction;  Proto-Oncogene Proteins c-bcr;  Reference Standards;  World Health Organization",
    abstract = "Molecular monitoring of chronic myeloid leukemia patients using robust BCR-ABL1 tests standardized to the International Scale (IS) is key to proper disease management, especially when treatment cessation is considered. Most laboratories currently use a time-consuming sample exchange process with reference laboratories for IS calibration. A World Health Organization (WHO) BCR-ABL1 reference panel was developed (MR 1 -MR 4), but access to the material is limited. In this study, we describe the development of the first cell-based secondary reference panel that is traceable to and faithfully replicates the WHO panel, with an additional MR 4.5 level. The secondary panel was calibrated to IS using digital PCR with ABL1, BCR and GUSB as reference genes and evaluated by 44 laboratories worldwide. Interestingly, we found that >40% of BCR-ABL1 assays showed signs of inadequate optimization such as poor linearity and suboptimal PCR efficiency. Nonetheless, when optimized sample inputs were used, >60% demonstrated satisfactory IS accuracy, precision and/or MR 4.5 sensitivity, and 58% obtained IS conversion factors from the secondary reference concordant with their current values. Correlation analysis indicated no significant alterations in %BCR-ABL1 results caused by different assay configurations. More assays achieved good precision and/or sensitivity than IS accuracy, indicating the need for better IS calibration mechanisms. © 2016 Macmillan Publishers Limited, part of Springer Nature."
}