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

Detalhes bibliográficos
Autor(a) principal: Baylis, S.A.
Data de Publicação: 2017
Outros Autores: Hanschmann, K-M.O., Schnierle, D.S., Trösemeier, J-H., Blümel, J., Zika Virus Collaborative Study Group
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10400.18/6047
Resumo: Zika Virus Collaborative Study Group - Portugal: Maria João Alves and Líbia Zé-Zé (Instituto Nacional de Saúde Doutor Ricardo Jorge.
id RCAP_f64f35f3c5d8bcfe48ae9fda9ec5150f
oai_identifier_str oai:repositorio.insa.pt:10400.18/6047
network_acronym_str RCAP
network_name_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository_id_str 7160
spelling Harmonization of nucleic acid testing for Zika virus: development of the 1st World Health Organization International StandardNucleic AcidZika VirusInfecções Sistémicas e ZoonosesZika Virus Collaborative Study Group - Portugal: Maria João Alves and Líbia Zé-Zé (Instituto Nacional de Saúde Doutor Ricardo Jorge.BACKGROUND: 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.Wiley/ AABB (American Association of Blood Banks)Repositório Científico do Instituto Nacional de SaúdeBaylis, S.A.Hanschmann, K-M.O.Schnierle, D.S.Trösemeier, J-H.Blümel, J.Zika Virus Collaborative Study Group2019-03-04T12:29:26Z2017-032017-03-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.18/6047engTransfusion. 2017 Mar;57(3pt2):748-761. doi: 10.1111/trf.14026. Epub 2017 Feb 23.0041-113210.1111/trf.14026info:eu-repo/semantics/embargoedAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-07-20T15:41:10Zoai:repositorio.insa.pt:10400.18/6047Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T18:40:40.715305Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Harmonization of nucleic acid testing for Zika virus: development of the 1st World Health Organization International Standard
title Harmonization of nucleic acid testing for Zika virus: development of the 1st World Health Organization International Standard
spellingShingle Harmonization of nucleic acid testing for Zika virus: development of the 1st World Health Organization International Standard
Baylis, S.A.
Nucleic Acid
Zika Virus
Infecções Sistémicas e Zoonoses
title_short Harmonization of nucleic acid testing for Zika virus: development of the 1st World Health Organization International Standard
title_full Harmonization of nucleic acid testing for Zika virus: development of the 1st World Health Organization International Standard
title_fullStr Harmonization of nucleic acid testing for Zika virus: development of the 1st World Health Organization International Standard
title_full_unstemmed Harmonization of nucleic acid testing for Zika virus: development of the 1st World Health Organization International Standard
title_sort Harmonization of nucleic acid testing for Zika virus: development of the 1st World Health Organization International Standard
author Baylis, S.A.
author_facet Baylis, S.A.
Hanschmann, K-M.O.
Schnierle, D.S.
Trösemeier, J-H.
Blümel, J.
Zika Virus Collaborative Study Group
author_role author
author2 Hanschmann, K-M.O.
Schnierle, D.S.
Trösemeier, J-H.
Blümel, J.
Zika Virus Collaborative Study Group
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Repositório Científico do Instituto Nacional de Saúde
dc.contributor.author.fl_str_mv Baylis, S.A.
Hanschmann, K-M.O.
Schnierle, D.S.
Trösemeier, J-H.
Blümel, J.
Zika Virus Collaborative Study Group
dc.subject.por.fl_str_mv Nucleic Acid
Zika Virus
Infecções Sistémicas e Zoonoses
topic Nucleic Acid
Zika Virus
Infecções Sistémicas e Zoonoses
description Zika Virus Collaborative Study Group - Portugal: Maria João Alves and Líbia Zé-Zé (Instituto Nacional de Saúde Doutor Ricardo Jorge.
publishDate 2017
dc.date.none.fl_str_mv 2017-03
2017-03-01T00:00:00Z
2019-03-04T12:29:26Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10400.18/6047
url http://hdl.handle.net/10400.18/6047
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Transfusion. 2017 Mar;57(3pt2):748-761. doi: 10.1111/trf.14026. Epub 2017 Feb 23.
0041-1132
10.1111/trf.14026
dc.rights.driver.fl_str_mv info:eu-repo/semantics/embargoedAccess
eu_rights_str_mv embargoedAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Wiley/ AABB (American Association of Blood Banks)
publisher.none.fl_str_mv Wiley/ AABB (American Association of Blood Banks)
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
repository.mail.fl_str_mv
_version_ 1799132149477015552

Registros relacionados