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

H White; L Deprez; P Corbisier; V Hall; F Lin; S Mazoua; S Trapmann; A Aggerholm; H Andrikovics; S Akiki; G Barbany; N Boeckx; A Bench; M Catherwood; JM Cayuela; S Chudleigh; T Clench; D Colomer; F Daraio; S Dulucq; J Farrugia; L Fletcher; L Foroni; R Ganderton; G Gerrard; E Gineikiene; S Hayette; H El Housni; B Izzo; M Jansson; P Johnels; T Jurcek; V Kairisto; A Kizilors; DW Kim; T de Lange; T Lion; KM Polakova; G Martinelli; S McCarron; PA Merle; B Milner; G Mitterbauer-Hohendanner; M Nagar; G Nickless; J Nomdedeu; DA Nymoen; EO Leibundgut; U (Ugur) Ozbek; T Pajic; H Pfeifer; C Preudhomme; K Raudsepp; G Romeo; T Sacha; R Talmaci; T Touloumenidou; Vincent van der Velden; P Waits; L (Liang) Wang; E Wilkinson; G Wilson; D Wren; R Zadro; J Ziermann; K Zoi; MC Mueller; A Hochhaus; H Schimmel; NCP Cross; H Emons

doi:10.1038/leu.2014.217

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

H White, L Deprez, P Corbisier, V Hall, F Lin, S Mazoua, S Trapmann, A Aggerholm, H Andrikovics, S Akiki, G Barbany, N Boeckx, A Bench, M Catherwood, JM Cayuela, S Chudleigh, T Clench, D Colomer, F Daraio, S DulucqJ Farrugia, L Fletcher, L Foroni, R Ganderton, G Gerrard, E Gineikiene, S Hayette, H El Housni, B Izzo, M Jansson, P Johnels, T Jurcek, V Kairisto, A Kizilors, DW Kim, T de Lange, T Lion, KM Polakova, G Martinelli, S McCarron, PA Merle, B Milner, G Mitterbauer-Hohendanner, M Nagar, G Nickless, J Nomdedeu, DA Nymoen, EO Leibundgut, U (Ugur) Ozbek, T Pajic, H Pfeifer, C Preudhomme, K Raudsepp, G Romeo, T Sacha, R Talmaci, T Touloumenidou, Vincent van der Velden, P Waits, L (Liang) Wang, E Wilkinson, G Wilson, D Wren, R Zadro, J Ziermann, K Zoi, MC Mueller, A Hochhaus, H Schimmel, NCP Cross, H Emons

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Abstract

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 x 10(6), 1.08 +/- 0.11 x 10(5), 1.03 +/- 0.10 x 10(4), 1.02 +/- 0.09 x 10(3), 1.04 +/- 0.10 x 10(2) and 10.0 +/- 1.5 copies/mu l. 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).

Original language	Undefined/Unknown
Pages (from-to)	369-376
Number of pages	8
Journal	Leukemia
Volume	29
Issue number	2
DOIs	https://doi.org/10.1038/leu.2014.217
Publication status	Published - 2015

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White, H., Deprez, L., Corbisier, P., Hall, V., Lin, F., Mazoua, S., Trapmann, S., Aggerholm, A., Andrikovics, H., Akiki, S., Barbany, G., Boeckx, N., Bench, A., Catherwood, M., Cayuela, JM., Chudleigh, S., Clench, T., Colomer, D., Daraio, F., ... Emons, H. (2015). A certified plasmid reference material for the standardisation of BCR-ABL1 mRNA quantification by real-time quantitative PCR. Leukemia, 29(2), 369-376. https://doi.org/10.1038/leu.2014.217

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title = "A certified plasmid reference material for the standardisation of BCR-ABL1 mRNA quantification by real-time quantitative PCR",

abstract = "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 x 10(6), 1.08 +/- 0.11 x 10(5), 1.03 +/- 0.10 x 10(4), 1.02 +/- 0.09 x 10(3), 1.04 +/- 0.10 x 10(2) and 10.0 +/- 1.5 copies/mu l. 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).",

author = "H White and L Deprez and P Corbisier and V Hall and F Lin and S Mazoua and S Trapmann and A Aggerholm and H Andrikovics and S Akiki and G Barbany and N Boeckx and A Bench and M Catherwood and JM Cayuela and S Chudleigh and T Clench and D Colomer and F Daraio and S Dulucq and J Farrugia and L Fletcher and L Foroni and R Ganderton and G Gerrard and E Gineikiene and S Hayette and {El Housni}, H and B Izzo and M Jansson and P Johnels and T Jurcek and V Kairisto and A Kizilors and DW Kim and {de Lange}, T and T Lion and KM Polakova and G Martinelli and S McCarron and PA Merle and B Milner and G Mitterbauer-Hohendanner and M Nagar and G Nickless and J Nomdedeu and DA Nymoen and EO Leibundgut and Ozbek, {U (Ugur)} and T Pajic and H Pfeifer and C Preudhomme and K Raudsepp and G Romeo and T Sacha and R Talmaci and T Touloumenidou and {van der Velden}, Vincent and P Waits and Wang, {L (Liang)} and E Wilkinson and G Wilson and D Wren and R Zadro and J Ziermann and K Zoi and MC Mueller and A Hochhaus and H Schimmel and NCP Cross and H Emons",

year = "2015",

doi = "10.1038/leu.2014.217",

language = "Undefined/Unknown",

volume = "29",

pages = "369--376",

journal = "Leukemia",

issn = "0887-6924",

publisher = "Nature Publishing Group",

number = "2",

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White, H, Deprez, L, Corbisier, P, Hall, V, Lin, F, Mazoua, S, Trapmann, S, Aggerholm, A, Andrikovics, H, Akiki, S, Barbany, G, Boeckx, N, Bench, A, Catherwood, M, Cayuela, JM, Chudleigh, S, Clench, T, Colomer, D, Daraio, F, Dulucq, S, Farrugia, J, Fletcher, L, Foroni, L, Ganderton, R, Gerrard, G, Gineikiene, E, Hayette, S, El Housni, H, Izzo, B, Jansson, M, Johnels, P, Jurcek, T, Kairisto, V, Kizilors, A, Kim, DW, de Lange, T, Lion, T, Polakova, KM, Martinelli, G, McCarron, S, Merle, PA, Milner, B, Mitterbauer-Hohendanner, G, Nagar, M, Nickless, G, Nomdedeu, J, Nymoen, DA, Leibundgut, EO, Ozbek, U, Pajic, T, Pfeifer, H, Preudhomme, C, Raudsepp, K, Romeo, G, Sacha, T, Talmaci, R, Touloumenidou, T, van der Velden, V, Waits, P, Wang, L, Wilkinson, E, Wilson, G, Wren, D, Zadro, R, Ziermann, J, Zoi, K, Mueller, MC, Hochhaus, A, Schimmel, H, Cross, NCP & Emons, H 2015, 'A certified plasmid reference material for the standardisation of BCR-ABL1 mRNA quantification by real-time quantitative PCR', Leukemia, vol. 29, no. 2, pp. 369-376. https://doi.org/10.1038/leu.2014.217

TY - JOUR

T1 - A certified plasmid reference material for the standardisation of BCR-ABL1 mRNA quantification by real-time quantitative PCR

AU - White, H

AU - Deprez, L

AU - Corbisier, P

AU - Hall, V

AU - Lin, F

AU - Mazoua, S

AU - Trapmann, S

AU - Aggerholm, A

AU - Andrikovics, H

AU - Akiki, S

AU - Barbany, G

AU - Boeckx, N

AU - Bench, A

AU - Catherwood, M

AU - Cayuela, JM

AU - Chudleigh, S

AU - Clench, T

AU - Colomer, D

AU - Daraio, F

AU - Dulucq, S

AU - Farrugia, J

AU - Fletcher, L

AU - Foroni, L

AU - Ganderton, R

AU - Gerrard, G

AU - Gineikiene, E

AU - Hayette, S

AU - El Housni, H

AU - Izzo, B

AU - Jansson, M

AU - Johnels, P

AU - Jurcek, T

AU - Kairisto, V

AU - Kizilors, A

AU - Kim, DW

AU - de Lange, T

AU - Lion, T

AU - Polakova, KM

AU - Martinelli, G

AU - McCarron, S

AU - Merle, PA

AU - Milner, B

AU - Mitterbauer-Hohendanner, G

AU - Nagar, M

AU - Nickless, G

AU - Nomdedeu, J

AU - Nymoen, DA

AU - Leibundgut, EO

AU - Ozbek, U (Ugur)

AU - Pajic, T

AU - Pfeifer, H

AU - Preudhomme, C

AU - Raudsepp, K

AU - Romeo, G

AU - Sacha, T

AU - Talmaci, R

AU - Touloumenidou, T

AU - van der Velden, Vincent

AU - Waits, P

AU - Wang, L (Liang)

AU - Wilkinson, E

AU - Wilson, G

AU - Wren, D

AU - Zadro, R

AU - Ziermann, J

AU - Zoi, K

AU - Mueller, MC

AU - Hochhaus, A

AU - Schimmel, H

AU - Cross, NCP

AU - Emons, H

PY - 2015

Y1 - 2015

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 x 10(6), 1.08 +/- 0.11 x 10(5), 1.03 +/- 0.10 x 10(4), 1.02 +/- 0.09 x 10(3), 1.04 +/- 0.10 x 10(2) and 10.0 +/- 1.5 copies/mu l. 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).

AB - 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 x 10(6), 1.08 +/- 0.11 x 10(5), 1.03 +/- 0.10 x 10(4), 1.02 +/- 0.09 x 10(3), 1.04 +/- 0.10 x 10(2) and 10.0 +/- 1.5 copies/mu l. 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).

U2 - 10.1038/leu.2014.217

DO - 10.1038/leu.2014.217

M3 - Article

SN - 0887-6924

VL - 29

SP - 369

EP - 376

JO - Leukemia

JF - Leukemia

IS - 2

ER -