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Harmonization of nucleic acid testing for Zika virus: development of the 1st World Health Organization International Standard

2017-03Journal article Restricted access
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dc.contributor.authorBaylis, S.A.
dc.contributor.authorHanschmann, K-M.O.
dc.contributor.authorSchnierle, D.S.
dc.contributor.authorTrösemeier, J-H.
dc.contributor.authorBlümel, J.
dc.contributor.authorZika Virus Collaborative Study Group
dc.date.accessioned2019-03-04T12:29:26Z
dc.date.available2019-03-04T12:29:26Z
dc.date.issued2017-03
dc.descriptionZika Virus Collaborative Study Group - Portugal: Maria João Alves and Líbia Zé-Zé (Instituto Nacional de Saúde Doutor Ricardo Jorge.pt_PT
dc.description.abstractBACKGROUND: With the ongoing public health emergency due to Zika virus (ZIKV), nucleic acid testing (NAT) is essential for clinical diagnosis and screening of blood donors. However, NAT for ZIKV has not been standardized, and this study was performed to establish a World Health Organization (WHO) International Standard (IS) for ZIKV RNA; WHO ISs have been used to improve detection and quantification of blood-borne viruses. STUDY DESIGN AND METHODS: The candidate IS (cIS), code number 11468/16, was prepared by heat inactivation and lyophilization of a ZIKV strain isolated from a patient in French Polynesia in 2013. The cIS was evaluated together with other reference materials, including both Asian and African ZIKV lineages as well as a panel of clinical samples and in vitro-transcribed RNAs. The samples for evaluation were distributed to 24 laboratories from 11 countries. The assays used consisted of a mixture of in-house developed and commercial assays (available or in development). RESULTS: The potencies of the standards were determined by quantitative and qualitative assays. In total, 37 sets of data were analyzed: 19 from quantitative assays and 18 from qualitative assays. Data demonstrated wide variations in reported potencies of the cIS and the other study samples. CONCLUSIONS: Assay variability was substantially reduced when ZIKV RNA concentrations from the biological reference materials and clinical samples were expressed relative to the cIS. Thus, the WHO has established 11468/16 as the 1st IS for ZIKV RNA, with a unitage of 50,000,000 IU/mL.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationTransfusion. 2017 Mar;57(3pt2):748-761. doi: 10.1111/trf.14026. Epub 2017 Feb 23.pt_PT
dc.identifier.doi10.1111/trf.14026pt_PT
dc.identifier.issn0041-1132
dc.identifier.urihttp://hdl.handle.net/10400.18/6047
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherWiley/ AABB (American Association of Blood Banks)pt_PT
dc.relation.publisherversionhttps://onlinelibrary.wiley.com/doi/full/10.1111/trf.14026pt_PT
dc.subjectNucleic Acidpt_PT
dc.subjectZika Viruspt_PT
dc.subjectInfecções Sistémicas e Zoonosespt_PT
dc.titleHarmonization of nucleic acid testing for Zika virus: development of the 1st World Health Organization International Standardpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage761pt_PT
oaire.citation.issue3pt2pt_PT
oaire.citation.startPage748pt_PT
oaire.citation.titleTransfusionpt_PT
oaire.citation.volume57pt_PT
rcaap.embargofctPolítica editorial da revistapt_PT
rcaap.rightsembargoedAccesspt_PT
rcaap.typearticlept_PT

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