A collaborative study to establish the 1st WHO International Standard for human cytomegalovirus for nucleic acid amplification technology.

Jacqueline F. Fryer; Alan B. Heath; Philip D. Minor; William Rawlinson; Guy Boivin; Jutta Preiksaitis; Xiao Li Pang; Côme Barranger; Sophie Alain; Céline Bressollette-Bodin; Klaus Hamprecht; Thomas Grewing; Pantelis Constantoulakis; Valeria Ghisetti; Maria R. Capobianchi; Isabella Abbate; Cristina Olivo; Tiziana Lazzarotto; Fausto Baldanti; Naoki Inoue; Fredrik Müller; Craig Corcoran; Diana Hardie; Jacqueline Prieto; Rob Schuurman; Anton van Loon; Shiaolan Ho; David Hillyard; Richard Hodinka; Marie Louise Landry; Angela Caliendo; Nell Lurain; Lee Sung; Margaret Gulley; Claire Atkinson; Jon Bible; Malcolm Guiver

doi:10.1016/j.biologicals.2016.04.005

A collaborative study to establish the 1st WHO International Standard for human cytomegalovirus for nucleic acid amplification technology.

Jacqueline F. Fryer, Alan B. Heath, Philip D. Minor, William Rawlinson, Guy Boivin, Jutta Preiksaitis, Xiao Li Pang, Côme Barranger, Sophie Alain, Céline Bressollette-Bodin, Klaus Hamprecht, Thomas Grewing, Pantelis Constantoulakis, Valeria Ghisetti, Maria R. Capobianchi, Isabella Abbate, Cristina Olivo, Tiziana Lazzarotto, Fausto Baldanti, Naoki InoueFredrik Müller, Craig Corcoran, Diana Hardie, Jacqueline Prieto, Rob Schuurman, Anton van Loon, Shiaolan Ho, David Hillyard, Richard Hodinka, Marie Louise Landry, Angela Caliendo, Nell Lurain, Lee Sung, Margaret Gulley, Claire Atkinson, Jon Bible, Malcolm Guiver

Human Sciences

Medicines and Healthcare Products Regulatory Agency

Research output: Contribution to journal › Article › peer-review

100 Citations (Scopus)

Abstract

Variability in the performance of nucleic acid amplification technology (NAT)-based assays presents a significant problem in the diagnosis and management of human cytomegalovirus (HCMV) infections. Here we describe a collaborative study to evaluate the suitability of candidate reference materials to harmonize HCMV viral load measurements in a wide range of NAT assays. Candidate materials comprised lyophilized Merlin virus, liquid Merlin virus, liquid AD169 virus, and purified HCMV Merlin DNA cloned into a bacterial artificial chromosome. Variability in the laboratory mean HCMV concentrations determined for virus samples across the different assays was 2 log10. Variability for the purified DNA sample was higher (>3 log10). The agreement between laboratories was markedly improved when the potencies of the liquid virus samples were expressed relative to the lyophilized virus candidate. In contrast, the agreement between laboratories for the purified DNA sample was not improved. Results indicated the suitability of the lyophilized Merlin virus preparation as the 1st WHO International Standard for HCMV for NAT. It was established in October 2010, with an assigned potency of 5 × 106 International Units (IU) (NIBSC code 09/162). It is intended to be used to calibrate secondary references, used in HCMV NAT assays, in IU.

Original language	English
Pages (from-to)	242-251
Number of pages	10
Journal	Biologicals
Volume	44
Issue number	4
DOIs	https://doi.org/10.1016/j.biologicals.2016.04.005 https://doi.org/10.1016/j.biologicals.2016.04.005
Publication status	Published - 11 May 2016

Bibliographical note

Publisher Copyright:
© 2016 The Authors

Keywords

CMV
Cytomegalovirus
International Standards
NAT
Standardization

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Fryer, J. F., Heath, A. B., Minor, P. D., Rawlinson, W., Boivin, G., Preiksaitis, J., Pang, X. L., Barranger, C., Alain, S., Bressollette-Bodin, C., Hamprecht, K., Grewing, T., Constantoulakis, P., Ghisetti, V., Capobianchi, M. R., Abbate, I., Olivo, C., Lazzarotto, T., Baldanti, F., ... Guiver, M. (2016). A collaborative study to establish the 1st WHO International Standard for human cytomegalovirus for nucleic acid amplification technology. Biologicals, 44(4), 242-251. https://doi.org/10.1016/j.biologicals.2016.04.005, https://doi.org/10.1016/j.biologicals.2016.04.005

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title = "A collaborative study to establish the 1st WHO International Standard for human cytomegalovirus for nucleic acid amplification technology.",

abstract = "Variability in the performance of nucleic acid amplification technology (NAT)-based assays presents a significant problem in the diagnosis and management of human cytomegalovirus (HCMV) infections. Here we describe a collaborative study to evaluate the suitability of candidate reference materials to harmonize HCMV viral load measurements in a wide range of NAT assays. Candidate materials comprised lyophilized Merlin virus, liquid Merlin virus, liquid AD169 virus, and purified HCMV Merlin DNA cloned into a bacterial artificial chromosome. Variability in the laboratory mean HCMV concentrations determined for virus samples across the different assays was 2 log10. Variability for the purified DNA sample was higher (>3 log10). The agreement between laboratories was markedly improved when the potencies of the liquid virus samples were expressed relative to the lyophilized virus candidate. In contrast, the agreement between laboratories for the purified DNA sample was not improved. Results indicated the suitability of the lyophilized Merlin virus preparation as the 1st WHO International Standard for HCMV for NAT. It was established in October 2010, with an assigned potency of 5 × 106 International Units (IU) (NIBSC code 09/162). It is intended to be used to calibrate secondary references, used in HCMV NAT assays, in IU.",

keywords = "CMV, Cytomegalovirus, International Standards, NAT, Standardization",

author = "Fryer, {Jacqueline F.} and Heath, {Alan B.} and Minor, {Philip D.} and William Rawlinson and Guy Boivin and Jutta Preiksaitis and Pang, {Xiao Li} and C{\^o}me Barranger and Sophie Alain and C{\'e}line Bressollette-Bodin and Klaus Hamprecht and Thomas Grewing and Pantelis Constantoulakis and Valeria Ghisetti and Capobianchi, {Maria R.} and Isabella Abbate and Cristina Olivo and Tiziana Lazzarotto and Fausto Baldanti and Naoki Inoue and Fredrik M{\"u}ller and Craig Corcoran and Diana Hardie and Jacqueline Prieto and Rob Schuurman and {van Loon}, Anton and Shiaolan Ho and David Hillyard and Richard Hodinka and {Louise Landry}, Marie and Angela Caliendo and Nell Lurain and Lee Sung and Margaret Gulley and Claire Atkinson and Jon Bible and Malcolm Guiver",

note = "Publisher Copyright: {\textcopyright} 2016 The Authors",

year = "2016",

month = may,

day = "11",

doi = "10.1016/j.biologicals.2016.04.005",

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Fryer, JF, Heath, AB, Minor, PD, Rawlinson, W, Boivin, G, Preiksaitis, J, Pang, XL, Barranger, C, Alain, S, Bressollette-Bodin, C, Hamprecht, K, Grewing, T, Constantoulakis, P, Ghisetti, V, Capobianchi, MR, Abbate, I, Olivo, C, Lazzarotto, T, Baldanti, F, Inoue, N, Müller, F, Corcoran, C, Hardie, D, Prieto, J, Schuurman, R, van Loon, A, Ho, S, Hillyard, D, Hodinka, R, Louise Landry, M, Caliendo, A, Lurain, N, Sung, L, Gulley, M, Atkinson, C, Bible, J & Guiver, M 2016, 'A collaborative study to establish the 1st WHO International Standard for human cytomegalovirus for nucleic acid amplification technology.', Biologicals, vol. 44, no. 4, pp. 242-251. https://doi.org/10.1016/j.biologicals.2016.04.005, https://doi.org/10.1016/j.biologicals.2016.04.005

TY - JOUR

T1 - A collaborative study to establish the 1st WHO International Standard for human cytomegalovirus for nucleic acid amplification technology.

AU - Fryer, Jacqueline F.

AU - Heath, Alan B.

AU - Minor, Philip D.

AU - Rawlinson, William

AU - Boivin, Guy

AU - Preiksaitis, Jutta

AU - Pang, Xiao Li

AU - Barranger, Côme

AU - Alain, Sophie

AU - Bressollette-Bodin, Céline

AU - Hamprecht, Klaus

AU - Grewing, Thomas

AU - Constantoulakis, Pantelis

AU - Ghisetti, Valeria

AU - Capobianchi, Maria R.

AU - Abbate, Isabella

AU - Olivo, Cristina

AU - Lazzarotto, Tiziana

AU - Baldanti, Fausto

AU - Inoue, Naoki

AU - Müller, Fredrik

AU - Corcoran, Craig

AU - Hardie, Diana

AU - Prieto, Jacqueline

AU - Schuurman, Rob

AU - van Loon, Anton

AU - Ho, Shiaolan

AU - Hillyard, David

AU - Hodinka, Richard

AU - Louise Landry, Marie

AU - Caliendo, Angela

AU - Lurain, Nell

AU - Sung, Lee

AU - Gulley, Margaret

AU - Atkinson, Claire

AU - Bible, Jon

AU - Guiver, Malcolm

PY - 2016/5/11

Y1 - 2016/5/11

N2 - Variability in the performance of nucleic acid amplification technology (NAT)-based assays presents a significant problem in the diagnosis and management of human cytomegalovirus (HCMV) infections. Here we describe a collaborative study to evaluate the suitability of candidate reference materials to harmonize HCMV viral load measurements in a wide range of NAT assays. Candidate materials comprised lyophilized Merlin virus, liquid Merlin virus, liquid AD169 virus, and purified HCMV Merlin DNA cloned into a bacterial artificial chromosome. Variability in the laboratory mean HCMV concentrations determined for virus samples across the different assays was 2 log10. Variability for the purified DNA sample was higher (>3 log10). The agreement between laboratories was markedly improved when the potencies of the liquid virus samples were expressed relative to the lyophilized virus candidate. In contrast, the agreement between laboratories for the purified DNA sample was not improved. Results indicated the suitability of the lyophilized Merlin virus preparation as the 1st WHO International Standard for HCMV for NAT. It was established in October 2010, with an assigned potency of 5 × 106 International Units (IU) (NIBSC code 09/162). It is intended to be used to calibrate secondary references, used in HCMV NAT assays, in IU.

AB - Variability in the performance of nucleic acid amplification technology (NAT)-based assays presents a significant problem in the diagnosis and management of human cytomegalovirus (HCMV) infections. Here we describe a collaborative study to evaluate the suitability of candidate reference materials to harmonize HCMV viral load measurements in a wide range of NAT assays. Candidate materials comprised lyophilized Merlin virus, liquid Merlin virus, liquid AD169 virus, and purified HCMV Merlin DNA cloned into a bacterial artificial chromosome. Variability in the laboratory mean HCMV concentrations determined for virus samples across the different assays was 2 log10. Variability for the purified DNA sample was higher (>3 log10). The agreement between laboratories was markedly improved when the potencies of the liquid virus samples were expressed relative to the lyophilized virus candidate. In contrast, the agreement between laboratories for the purified DNA sample was not improved. Results indicated the suitability of the lyophilized Merlin virus preparation as the 1st WHO International Standard for HCMV for NAT. It was established in October 2010, with an assigned potency of 5 × 106 International Units (IU) (NIBSC code 09/162). It is intended to be used to calibrate secondary references, used in HCMV NAT assays, in IU.

KW - CMV

KW - Cytomegalovirus

KW - International Standards

KW - NAT

KW - Standardization

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U2 - 10.1016/j.biologicals.2016.04.005

DO - 10.1016/j.biologicals.2016.04.005

M3 - Article

SN - 1095-8320

VL - 44

SP - 242

EP - 251

JO - Biologicals

JF - Biologicals

IS - 4

ER -

A collaborative study to establish the 1st WHO International Standard for human cytomegalovirus for nucleic acid amplification technology.

Abstract

Bibliographical note

Keywords

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