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A certified plasmid reference material for the standardisation of BCR-ABL1 mRNA quantification by real time quantitative PCR.

White, H; Deprez, L; Corbisier, P; Hall, V; Lin, F; Mazoua, S; Trapmann, S; Aggerholm, A; Andrikovics, H and Akiki, S, et al. (2015) In Leukemia 29(2). p.369-376
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 × 10(6), 1.08±0.11 × 10(5), 1.03±0.10 × 10(4), 1.02±0.09 × 10(3), 1.04±0.10 × 10(2) and 10.0±1.5 copies/μL. The... (More)
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 × 10(6), 1.08±0.11 × 10(5), 1.03±0.10 × 10(4), 1.02±0.09 × 10(3), 1.04±0.10 × 10(2) 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 the numbers of measured transcripts of e14a2 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).Leukemia accepted article preview online, 18 July 2014; doi:10.1038/leu.2014.217. (Less)
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Leukemia
volume
29
issue
2
pages
369 - 376
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Nature Publishing Group
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  • pmid:25036192
  • wos:000349445000013
  • scopus:84922537430
ISSN
1476-5551
DOI
10.1038/leu.2014.217
language
English
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yes
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c3f3c44c-5e55-4655-a579-7edee4d4ca9e (old id 4581987)
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http://www.ncbi.nlm.nih.gov/pubmed/25036192?dopt=Abstract
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2014-08-08 01:31:32
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2017-11-05 03:25:59
@article{c3f3c44c-5e55-4655-a579-7edee4d4ca9e,
  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 × 10(6), 1.08±0.11 × 10(5), 1.03±0.10 × 10(4), 1.02±0.09 × 10(3), 1.04±0.10 × 10(2) 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 the numbers of measured transcripts of e14a2 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).Leukemia accepted article preview online, 18 July 2014; doi:10.1038/leu.2014.217.},
  author       = {White, H and Deprez, L and Corbisier, P and Hall, V and Lin, F and Mazoua, S and Trapmann, S and Aggerholm, A and Andrikovics, H and Akiki, S and Barbany, G and Boeckx, N and Bench, A and Catherwood, M and Cayuela, J-M and Chudleigh, S and Clench, T and Colomer, D and Daraio, F and Dulucq, S and Farrugia, J and Fletcher, L and Foroni, L and Ganderton, R and Gerrard, G and Gineikienė, E and Hayette, S and El Housni, H and Izzo, B and Jansson, M and Johnels, Petra and Jurcek, T and Kairisto, V and Kizilors, A and Kim, D-W and Lange, T and Lion, T and Polakova, K M and Martinelli, G and McCarron, S and Merle, P A and Milner, B and Mitterbauer-Hohendanner, G and Nagar, M and Nickless, G and Nomdedéu, J and Nymoen, D A and Leibundgut, E O and Ozbek, U and Pajič, T and Pfeifer, H and Preudhomme, C and Raudsepp, K and Romeo, G and Sacha, T and Talmaci, R and Touloumenidou, T and Van der Velden, V H J and Waits, P and Wang, L and Wilkinson, E and Wilson, G and Wren, D and Zadro, R and Ziermann, J and Zoi, K and Müller, M C and Hochhaus, A and Schimmel, H and Cross, N C P and Emons, H},
  issn         = {1476-5551},
  language     = {eng},
  number       = {2},
  pages        = {369--376},
  publisher    = {Nature Publishing Group},
  series       = {Leukemia},
  title        = {A certified plasmid reference material for the standardisation of BCR-ABL1 mRNA quantification by real time quantitative PCR.},
  url          = {http://dx.doi.org/10.1038/leu.2014.217},
  volume       = {29},
  year         = {2015},
}