The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control

To evaluate molecular assays for Mpox diagnosis available in various clinical microbiology services in Spain through a quality control (QC) approach. A total of 14 centers from across Spain participated in the study. The Reference Laboratory dispatched eight serum samples and eight nucleic acid extr...

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Autores: de Salazar A, Martínez MJ, Navero-Castillejos J, Negredo A, Galán JC, Rojo Molinero E, Lagarejos E, Muñoz-Almagro C, Hernández Rodríguez Á, Lepe JA, Antón Pagarolas A, Pérez Castro S, Zamora Cintas MI, Domínguez-Gil González M, Niubó-Bosch J, Gutiérrez Arroyo A, Vazquez A, García F, Sánchez-Seco Fariñas MP
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Fundació Sant Joan de Déu
Repositorio:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
OAI Identifier:oai:fsjd.fundanetsuite.com:p24924
Acceso en línea:https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=24924
Access Level:acceso abierto
Palabra clave:Monkeypox
PCR
quality control
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spelling The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality controlde Salazar AMartínez MJNavero-Castillejos JNegredo AGalán JCRojo Molinero ELagarejos EMuñoz-Almagro CHernández Rodríguez ÁLepe JAAntón Pagarolas APérez Castro SZamora Cintas MIDomínguez-Gil González MNiubó-Bosch JGutiérrez Arroyo AVazquez AGarcía FSánchez-Seco Fariñas MPMonkeypoxPCRquality controlTo evaluate molecular assays for Mpox diagnosis available in various clinical microbiology services in Spain through a quality control (QC) approach. A total of 14 centers from across Spain participated in the study. The Reference Laboratory dispatched eight serum samples and eight nucleic acid extracts to each participating center. Some samples were spiked with Mpox or Vaccinia virus to mimic positive samples for Mpox or other orthopox viruses. Participating centers provided information on the results obtained, as well as the laboratory methods used. Among the 14 participating centers seven different commercial assays were employed, with the most commonly used kit being LightMix Modular Orthopox/Monkeypox (Mpox) Virus (Roche((R))). Of the 12 centers conducting Mpox determinations, concordance ranged from 62.5% (n=1) to 100% (n=11) for eluates and from 75.0% (n=1) to 100% (n=10) for serum. Among the 10 centers performing Orthopoxvirus determinations, a 100% concordance was observed for eluates, while for serum, concordance ranged from 87.5% (n=6) to 100% (n=4). Repeatedly, 6 different centers reported a false negative in serum samples for Orthopoxvirus diagnosis, particularly in a sample with borderline C-t=39. Conversely, one center, using the TaqMan (TM) Mpox Virus Microbe Detection Assay (Thermo Fisher), reported false positives in Mpox diagnosis for samples spiked with vaccinia virus due to cross-reactions. We observed a positive correlation of various diagnostic assays for Mpox used by the participating centers with the reference values. Our results highlight the significance of standardization, validation, and ongoing QC in the microbiological diagnosis of infectious diseases, which might be particularly relevant for emerging viruses.WILEY2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=24924JOURNAL OF MEDICAL VIROLOGYISSN: 01466615ISSNe: 10969071reponame:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déuinstname:Fundació Sant Joan de DéuInglésinfo:eu-repo/semantics/openAccessoai:fsjd.fundanetsuite.com:p249242026-05-27T12:37:41Z
dc.title.none.fl_str_mv The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control
title The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control
spellingShingle The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control
de Salazar A
Monkeypox
PCR
quality control
title_short The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control
title_full The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control
title_fullStr The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control
title_full_unstemmed The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control
title_sort The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control
dc.creator.none.fl_str_mv de Salazar A
Martínez MJ
Navero-Castillejos J
Negredo A
Galán JC
Rojo Molinero E
Lagarejos E
Muñoz-Almagro C
Hernández Rodríguez Á
Lepe JA
Antón Pagarolas A
Pérez Castro S
Zamora Cintas MI
Domínguez-Gil González M
Niubó-Bosch J
Gutiérrez Arroyo A
Vazquez A
García F
Sánchez-Seco Fariñas MP
author de Salazar A
author_facet de Salazar A
Martínez MJ
Navero-Castillejos J
Negredo A
Galán JC
Rojo Molinero E
Lagarejos E
Muñoz-Almagro C
Hernández Rodríguez Á
Lepe JA
Antón Pagarolas A
Pérez Castro S
Zamora Cintas MI
Domínguez-Gil González M
Niubó-Bosch J
Gutiérrez Arroyo A
Vazquez A
García F
Sánchez-Seco Fariñas MP
author_role author
author2 Martínez MJ
Navero-Castillejos J
Negredo A
Galán JC
Rojo Molinero E
Lagarejos E
Muñoz-Almagro C
Hernández Rodríguez Á
Lepe JA
Antón Pagarolas A
Pérez Castro S
Zamora Cintas MI
Domínguez-Gil González M
Niubó-Bosch J
Gutiérrez Arroyo A
Vazquez A
García F
Sánchez-Seco Fariñas MP
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Monkeypox
PCR
quality control
topic Monkeypox
PCR
quality control
description To evaluate molecular assays for Mpox diagnosis available in various clinical microbiology services in Spain through a quality control (QC) approach. A total of 14 centers from across Spain participated in the study. The Reference Laboratory dispatched eight serum samples and eight nucleic acid extracts to each participating center. Some samples were spiked with Mpox or Vaccinia virus to mimic positive samples for Mpox or other orthopox viruses. Participating centers provided information on the results obtained, as well as the laboratory methods used. Among the 14 participating centers seven different commercial assays were employed, with the most commonly used kit being LightMix Modular Orthopox/Monkeypox (Mpox) Virus (Roche((R))). Of the 12 centers conducting Mpox determinations, concordance ranged from 62.5% (n=1) to 100% (n=11) for eluates and from 75.0% (n=1) to 100% (n=10) for serum. Among the 10 centers performing Orthopoxvirus determinations, a 100% concordance was observed for eluates, while for serum, concordance ranged from 87.5% (n=6) to 100% (n=4). Repeatedly, 6 different centers reported a false negative in serum samples for Orthopoxvirus diagnosis, particularly in a sample with borderline C-t=39. Conversely, one center, using the TaqMan (TM) Mpox Virus Microbe Detection Assay (Thermo Fisher), reported false positives in Mpox diagnosis for samples spiked with vaccinia virus due to cross-reactions. We observed a positive correlation of various diagnostic assays for Mpox used by the participating centers with the reference values. Our results highlight the significance of standardization, validation, and ongoing QC in the microbiological diagnosis of infectious diseases, which might be particularly relevant for emerging viruses.
publishDate 2023
dc.date.none.fl_str_mv 2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=24924
url https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=24924
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv WILEY
publisher.none.fl_str_mv WILEY
dc.source.none.fl_str_mv JOURNAL OF MEDICAL VIROLOGY
ISSN: 01466615
ISSNe: 10969071
reponame:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
instname:Fundació Sant Joan de Déu
instname_str Fundació Sant Joan de Déu
reponame_str r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
collection r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,811543

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