TY - JOUR A1 - White, Helen A1 - Deprez, Liesbet A1 - Corbisier, Philippe A1 - Hall, Victoria A1 - Lin, Feng A1 - Mazoua, Stéphane A1 - Trapmann, Stefanie A1 - Aggerholm, Anni A1 - Andrikovics, Hajnalka A1 - Akiki, Susanna A1 - Barbany, Gisela A1 - Boeckx, Nancy A1 - Bench, Anthony A1 - Catherwood, Mark A1 - Cayuela, Jean-Michel A1 - Chudleigh, Sandra A1 - Clench, Tim A1 - Colomer, Dolors A1 - Daraio, Filomena A1 - Dulucq, Stephanie A1 - Farrugia, Joanna A1 - Fletcher, Linda A1 - Foroni, Letizia A1 - Ganderton, Ros A1 - Gerrard, Gareth A1 - Gineikienė, Eglė A1 - Hayette, Sandrine A1 - El Housni, Hakim A1 - Izzo, Barbara A1 - Jansson, Mattias A1 - Johnels, Petra A1 - Jurcek, Tomas A1 - Kairisto, Veli A1 - Kizilors, Aytug A1 - Kim, Dong-Wook A1 - Lange, Thoralf A1 - Lion, Thomas A1 - Polakova, Katerina Machova A1 - Martinelli, Giovanni A1 - McCarron, Sarah A1 - Merle, Pauline A. A1 - Milner, Ben A1 - Mitterbauer-Hohendanner, Gerlinde A1 - Nagar, Meital A1 - Nickless, Guillermina A1 - Nomdedéu, Josep F. A1 - Nymoen, Dag A. A1 - Leibundgut, Elisabeth Oppliger A1 - Ozbek, Ugur A1 - Pajič, Tadej A1 - Pfeifer, Heike A1 - Preudhomme, Claude A1 - Raudsepp, Kadri A1 - Romeo, Giuliana A1 - Sacha, Tomasz A1 - Talmaci, Rodica A1 - Touloumenidou, Tasoula A1 - Van der Velden, Vincent H. J. A1 - Waits, Paula A1 - Wang, Lihui A1 - Wilkinson, Elizabeth A1 - Wilson, Gill A1 - Wren, Dörte A1 - Zadro, Renata A1 - Ziermann, Janine A1 - Zoi, Katerina A1 - Müller, Martin C. A1 - Hochhaus, Andreas A1 - Schimmel, Heinz A1 - Cross, Nicholas C. P. A1 - Emons, Hendrik T1 - A certified plasmid reference material for the standardisation of BCR–ABL1 mRNA quantification by real-time quantitative PCR T2 - Leukemia, 29.2015, S. 369–376 N2 - Serial quantification of BCR–ABL1 mRNA is an important therapeutic indicator in chronic myeloid leukaemia, but there is a substantial variation in results reported by different laboratories. To improve comparability, an internationally accepted plasmid certified reference material (CRM) was developed according to ISO Guide 34:2009. Fragments of BCR–ABL1 (e14a2 mRNA fusion), BCR and GUSB transcripts were amplified and cloned into pUC18 to yield plasmid pIRMM0099. Six different linearised plasmid solutions were produced with the following copy number concentrations, assigned by digital PCR, and expanded uncertainties: 1.08±0.13 × 106, 1.08±0.11 × 105, 1.03±0.10 × 104, 1.02±0.09 × 103, 1.04±0.10 × 102 and 10.0±1.5 copies/μl. The certification of the material for the number of specific DNA fragments per plasmid, copy number concentration of the plasmid solutions and the assessment of inter-unit heterogeneity and stability were performed according to ISO Guide 35:2006. Two suitability studies performed by 63 BCR–ABL1 testing laboratories demonstrated that this set of 6 plasmid CRMs can help to standardise a number of measured transcripts of e14a2 BCR–ABL1 and three control genes (ABL1, BCR and GUSB). The set of six plasmid CRMs is distributed worldwide by the Institute for Reference Materials and Measurements (Belgium) and its authorised distributors (https://ec.europa.eu/jrc/en/reference-materials/catalogue/; CRM code ERM-AD623a-f). Y1 - 2014 UR - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/37308 UR - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-373087 SN - 1476-5551 SN - 0887-6924 N1 - Copyright © 2015 Macmillan Publishers Limited. This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ VL - 29 IS - 2 SP - 369 EP - 376 PB - Nature Publ. Group CY - Basingstoke ER -