Title: A certified plasmid reference material for the standardisation of BCR-ABL1 mRNA quantification by real-time quantitative PCR
Authors: WHITE HelenDEPREZ LIESBETCORBISIER PhilippeHALL VictoriaLIN FengMAZOUA StephaneTRAPMANN StefanieAGGERHOLM AnnieANDRIKOVICS HajnalkaAKIKI SusannaBARBANY GiselaBOECKX NancyBENCH AnthonyCATHERWOOD MarkCAYUELA Jean-MichelCHUDLEIGH SandraCLENCH TimCOLOMER DDARAIO FilomenaDULUCQ StephanieFARRUGIA JoannaFLETCHER LindaFORONI LetiziaGANDERTON RosGERRARD GarethGINEIKIENĖ EglėHAYETTE SandrineEL HOUSNI HakimIZZO BarbaraJANSSON MattiasJOHNELS PetraJURCEK TomasKAIRISTO VeliKIZILORS AytugKIM Dong-WookLANGE ThoralfLION ThomasMACHOVA POLAKOVA KaterinaMARTINELLI GiovanniMCCARRON SarahMERLE Pauline A.MILNER BenMITTERBAUER-HOHENDANNER GerlindeNAGAR MeitalNICKLESS GuillerminaNOMDEDÉU JosepNYMOEN Dag A.OPPLIGER LEIBUNDGUT ElisabethOZBEK UgurPAJIČ TadejPFEIFER HeikePREUDHOMME ClaudeRAUDSEPP KadriROMEO GiulianaSACHA TomaszTALMACI RodicaTOULOUMENIDOU TasoulaVAN DER VELDEN Vincent HjWAITS PaulaWANG LihuiWILKINSON ElizabethWILSON GillWREN DörteZADRO RenataZIERMANN JanineZOI KaterinaMÜLLER MartinHOCHHAUS AndreasSCHIMMEL HeinzCROSS NicholasEMONS Hendrik
Citation: LEUKEMIA vol. 29 p. 369–376
Publisher: NATURE PUBLISHING GROUP
Publication Year: 2015
JRC N°: JRC89773
ISSN: 0887-6924
URI: http://www.nature.com/leu/journal/v29/n2/full/leu2014217a.html
http://publications.jrc.ec.europa.eu/repository/handle/JRC89773
DOI: 10.1038/leu.2014.217
Type: Articles in periodicals and books
Abstract: Serial quantification of BCR-ABL1 mRNA is an important therapeutic indicator in chronic myeloid leukemia, but there is 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 and the 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 the numbers of measured transcripts of BCR-ABL1 and three control genes; ABL1, BCR and GUSB. The set of 6 plasmid CRMs is distributed worldwide by the Institute for Reference Materials and Measurements (Belgium) and its authorised distributors (http://irmm.jrc.ec.europa.eu; CRM code ERM-AD623a-f).
JRC Directorate:Health, Consumers and Reference Materials

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