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

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• 作者：Jacqueline F. Fryer^a ; ^{Jacqueline.Fryer@nibsc.org" class="auth_mail" title="E-mail the corresponding author} ; Alan B. Heath^b ; Philip D. Minor^a ; the Collaborative Study Group¹ ; Harald Kessler ; William Rawlinson ; Guy Boivin ; Jutta Preiksaitis ; Xiao-Li Pang ; Cô ; me Barranger ; Sophie Alain ; Cé ; line Bressollette-Bodin ; Klaus Hamprecht ; Thomas Grewing ; Pantelis Constantoulakis ; Valeria Ghisetti ; Maria R. Capobianchi ; Isabella Abbate ; Cristina Olivo ; Tiziana Lazzarotto ; Fausto Baldanti ; Naoki Inoue ; Fredrik Mü ; ller ; 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
• 关键词：Cytomegalovirus ; CMV ; NAT ; International Standards ; Standardization
• 刊名：Biologicals
• 出版年：2016
• 出版时间：July 2016
• 年：2016
• 卷：44
• 期：4
• 页码：242-251
• 全文大小：577 K

文摘

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.