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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
A collaborative study to establish the 1st WHO International Standard for human cytomegalovirus for nucleic acid amplification technology
Biologicals, Volume 44, No. 4, Year 2016
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Description
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. © 2016 The Authors
Authors & Co-Authors
Heath, Alan B.
United Kingdom, Hertfordshire
National Institute for Biological Standards and Control
Minor, Phillip D.
United Kingdom, Hertfordshire
National Institute for Biological Standards and Control
Rawlinson, William D.
Unknown Affiliation
Boivin, Guy
Unknown Affiliation
Pang, Xiaoli Lilly
Unknown Affiliation
Alain, Sophie
Unknown Affiliation
Bressollette-Bodin, Céline
Unknown Affiliation
Grewing, Thomas
Unknown Affiliation
Capobianchi, Maria Rosaria
Unknown Affiliation
Abbate, I.
Unknown Affiliation
Lazzarotto, Tiziana
Unknown Affiliation
Baldanti, F.
Unknown Affiliation
Corcoran, Craig
Unknown Affiliation
Hardie, Diana Ruth
Unknown Affiliation
Schuurman, Rob J.
Unknown Affiliation
van Loon, Anton M.
Unknown Affiliation
Hodinka, Richard L.
Unknown Affiliation
Caliendo, Angela M.
Unknown Affiliation
Gulley, Margaret L.
Unknown Affiliation
Atkinson, Claire E.
Unknown Affiliation
Guiver, Malcolm
Unknown Affiliation
Statistics
Citations: 87
Authors: 21
Affiliations: 1
Identifiers
Doi:
10.1016/j.biologicals.2016.04.005
ISSN:
10451056
Research Areas
Genetics And Genomics