First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA

Autores
Chudy, M.; Hanschmann, K. M.; Kress, J.; Nick, S.; Campos, Rodolfo Hector; Wend, U.; Gerlich, W.; Nübling, C. M.
Año de publicación
2012
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Background: WHO International Standards (IS) are provided for the calibration and validation of diagnostic and screening assays, e.g. for hepatitis B virus (HBV). HBV forms numerous subgenotypes and the current IS for HBV DNA reflects subgenotype A2. Objective: A reference panel with the most prevalent subgenotypes should facilitate evaluation of genotype-specific detection efficiencies. Study design: 215 HBV positive plasma samples collected worldwide were characterized for HBV markers and sequenced. Fifteen subgenotype A1, A2, B2, B4, C2, D1, D3, E, F2 and G samples were selected for the panel. The lyophilized samples were tested in parallel with the IS in an international collaborative study with 16 laboratories using 13 different nucleic acid amplification techniques (NATs). Results: Eight of 13 NAT had a HBV DNA detection efficiency which was independent of the genotype and consistent with the IS, while with five assays, certain deviations were noted, particularly with genotype F which was under quantitated or even missed by three assays. The panel was accepted by the WHO as the " 1st WHO International Reference Panel for HBV Genotypes for HBV NAT-Based Assays". Conclusions: The evaluation of HBV DNA assays should include many different genotypes. The WHO Reference Panel is universally available for manufacturers of HBV DNA assays, diagnostic laboratories and control authorities to facilitate standardized validation of HBV genotype specific detection efficiency of both diagnostic (quantitative and qualitative) and screening NAT assays.
Fil: Chudy, M.. No especifíca;
Fil: Hanschmann, K. M.. No especifíca;
Fil: Kress, J.. No especifíca;
Fil: Nick, S.. No especifíca;
Fil: Campos, Rodolfo Hector. Universidad de Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Wend, U.. No especifíca;
Fil: Gerlich, W.. No especifíca;
Fil: Nübling, C. M.. No especifíca;
Materia
CALIBRATION
HBV DNA
HBV GENOTYPES
HBV NAT
IVD
VALIDATION
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/196728
Acceder
id CONICETDig_ae2437c1879f4fbc54f58fd30ac4db5b
oai_identifier_str oai:ri.conicet.gov.ar:11336/196728
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNAChudy, M.Hanschmann, K. M.Kress, J.Nick, S.Campos, Rodolfo HectorWend, U.Gerlich, W.Nübling, C. M.CALIBRATIONHBV DNAHBV GENOTYPESHBV NATIVDVALIDATIONhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Background: WHO International Standards (IS) are provided for the calibration and validation of diagnostic and screening assays, e.g. for hepatitis B virus (HBV). HBV forms numerous subgenotypes and the current IS for HBV DNA reflects subgenotype A2. Objective: A reference panel with the most prevalent subgenotypes should facilitate evaluation of genotype-specific detection efficiencies. Study design: 215 HBV positive plasma samples collected worldwide were characterized for HBV markers and sequenced. Fifteen subgenotype A1, A2, B2, B4, C2, D1, D3, E, F2 and G samples were selected for the panel. The lyophilized samples were tested in parallel with the IS in an international collaborative study with 16 laboratories using 13 different nucleic acid amplification techniques (NATs). Results: Eight of 13 NAT had a HBV DNA detection efficiency which was independent of the genotype and consistent with the IS, while with five assays, certain deviations were noted, particularly with genotype F which was under quantitated or even missed by three assays. The panel was accepted by the WHO as the " 1st WHO International Reference Panel for HBV Genotypes for HBV NAT-Based Assays". Conclusions: The evaluation of HBV DNA assays should include many different genotypes. The WHO Reference Panel is universally available for manufacturers of HBV DNA assays, diagnostic laboratories and control authorities to facilitate standardized validation of HBV genotype specific detection efficiency of both diagnostic (quantitative and qualitative) and screening NAT assays.Fil: Chudy, M.. No especifíca;Fil: Hanschmann, K. M.. No especifíca;Fil: Kress, J.. No especifíca;Fil: Nick, S.. No especifíca;Fil: Campos, Rodolfo Hector. Universidad de Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Wend, U.. No especifíca;Fil: Gerlich, W.. No especifíca;Fil: Nübling, C. M.. No especifíca;Elsevier Science2012-08info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/196728Chudy, M.; Hanschmann, K. M.; Kress, J.; Nick, S.; Campos, Rodolfo Hector; et al.; First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA; Elsevier Science; Journal of Clinical Virology; 55; 4; 8-2012; 303-3091386-6532CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S1386653212003174info:eu-repo/semantics/altIdentifier/doi/10.1016/j.jcv.2012.08.013info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T09:43:37Zoai:ri.conicet.gov.ar:11336/196728instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-03 09:43:37.452CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA
title First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA
spellingShingle First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA
Chudy, M.
CALIBRATION
HBV DNA
HBV GENOTYPES
HBV NAT
IVD
VALIDATION
title_short First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA
title_full First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA
title_fullStr First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA
title_full_unstemmed First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA
title_sort First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA
dc.creator.none.fl_str_mv Chudy, M.
Hanschmann, K. M.
Kress, J.
Nick, S.
Campos, Rodolfo Hector
Wend, U.
Gerlich, W.
Nübling, C. M.
author Chudy, M.
author_facet Chudy, M.
Hanschmann, K. M.
Kress, J.
Nick, S.
Campos, Rodolfo Hector
Wend, U.
Gerlich, W.
Nübling, C. M.
author_role author
author2 Hanschmann, K. M.
Kress, J.
Nick, S.
Campos, Rodolfo Hector
Wend, U.
Gerlich, W.
Nübling, C. M.
author2_role author
author
author
author
author
author
author
dc.subject.none.fl_str_mv CALIBRATION
HBV DNA
HBV GENOTYPES
HBV NAT
IVD
VALIDATION
topic CALIBRATION
HBV DNA
HBV GENOTYPES
HBV NAT
IVD
VALIDATION
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Background: WHO International Standards (IS) are provided for the calibration and validation of diagnostic and screening assays, e.g. for hepatitis B virus (HBV). HBV forms numerous subgenotypes and the current IS for HBV DNA reflects subgenotype A2. Objective: A reference panel with the most prevalent subgenotypes should facilitate evaluation of genotype-specific detection efficiencies. Study design: 215 HBV positive plasma samples collected worldwide were characterized for HBV markers and sequenced. Fifteen subgenotype A1, A2, B2, B4, C2, D1, D3, E, F2 and G samples were selected for the panel. The lyophilized samples were tested in parallel with the IS in an international collaborative study with 16 laboratories using 13 different nucleic acid amplification techniques (NATs). Results: Eight of 13 NAT had a HBV DNA detection efficiency which was independent of the genotype and consistent with the IS, while with five assays, certain deviations were noted, particularly with genotype F which was under quantitated or even missed by three assays. The panel was accepted by the WHO as the " 1st WHO International Reference Panel for HBV Genotypes for HBV NAT-Based Assays". Conclusions: The evaluation of HBV DNA assays should include many different genotypes. The WHO Reference Panel is universally available for manufacturers of HBV DNA assays, diagnostic laboratories and control authorities to facilitate standardized validation of HBV genotype specific detection efficiency of both diagnostic (quantitative and qualitative) and screening NAT assays.
Fil: Chudy, M.. No especifíca;
Fil: Hanschmann, K. M.. No especifíca;
Fil: Kress, J.. No especifíca;
Fil: Nick, S.. No especifíca;
Fil: Campos, Rodolfo Hector. Universidad de Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Wend, U.. No especifíca;
Fil: Gerlich, W.. No especifíca;
Fil: Nübling, C. M.. No especifíca;
description Background: WHO International Standards (IS) are provided for the calibration and validation of diagnostic and screening assays, e.g. for hepatitis B virus (HBV). HBV forms numerous subgenotypes and the current IS for HBV DNA reflects subgenotype A2. Objective: A reference panel with the most prevalent subgenotypes should facilitate evaluation of genotype-specific detection efficiencies. Study design: 215 HBV positive plasma samples collected worldwide were characterized for HBV markers and sequenced. Fifteen subgenotype A1, A2, B2, B4, C2, D1, D3, E, F2 and G samples were selected for the panel. The lyophilized samples were tested in parallel with the IS in an international collaborative study with 16 laboratories using 13 different nucleic acid amplification techniques (NATs). Results: Eight of 13 NAT had a HBV DNA detection efficiency which was independent of the genotype and consistent with the IS, while with five assays, certain deviations were noted, particularly with genotype F which was under quantitated or even missed by three assays. The panel was accepted by the WHO as the " 1st WHO International Reference Panel for HBV Genotypes for HBV NAT-Based Assays". Conclusions: The evaluation of HBV DNA assays should include many different genotypes. The WHO Reference Panel is universally available for manufacturers of HBV DNA assays, diagnostic laboratories and control authorities to facilitate standardized validation of HBV genotype specific detection efficiency of both diagnostic (quantitative and qualitative) and screening NAT assays.
publishDate 2012
dc.date.none.fl_str_mv 2012-08
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/196728
Chudy, M.; Hanschmann, K. M.; Kress, J.; Nick, S.; Campos, Rodolfo Hector; et al.; First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA; Elsevier Science; Journal of Clinical Virology; 55; 4; 8-2012; 303-309
1386-6532
CONICET Digital
CONICET
url http://hdl.handle.net/11336/196728
identifier_str_mv Chudy, M.; Hanschmann, K. M.; Kress, J.; Nick, S.; Campos, Rodolfo Hector; et al.; First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA; Elsevier Science; Journal of Clinical Virology; 55; 4; 8-2012; 303-309
1386-6532
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S1386653212003174
info:eu-repo/semantics/altIdentifier/doi/10.1016/j.jcv.2012.08.013
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier Science
publisher.none.fl_str_mv Elsevier Science
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
_version_ 1842268613827887104
score 13.13397

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