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...
| Autores: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Fecha de publicación: | 2023 |
| País: | España |
| Institución: | Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| Repositorio: | Recercat. Dipósit de la Recerca de Catalunya |
| OAI Identifier: | oai:recercat.cat:20.500.12328/3877 |
| Acceso en línea: | http://hdl.handle.net/20.500.12328/3877 https://dx.doi.org/10.1002/jmv.29240 |
| Access Level: | acceso abierto |
| Palabra clave: | Viruela del mono PCR Control de calidad Verola del mico Control de qualitat Monkeypox Quality control 61 |
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The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality controlDe Salazar, AdolfoMartínez, Miguel J.Navero-Castillejos, JessicaNegredo, AnabelGalán, Juan CarlosRojo Molinero, EstrellaLagarejos, EduardoMuñoz-Almagro, CarmenHernández Rodríguez, ÁguedaLepe, José AntonioAntón Pagarolas, AndrésPérez Castro, SoniaZamora Cintas, María IsabelDomínguez-Gil González, MartaNiubó-Bosch, JordiGutiérrez Arroyo, AlmudenaVazquez, AnaGarcía, FedericoSánchez-Seco Fariñas, María PazViruela del monoPCRControl de calidadVerola del micoPCRControl de qualitatMonkeypoxPCRQuality control61To 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®). 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 Ct = 39. Conversely, one center, using the TaqMan™ 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.info:eu-repo/semantics/publishedVersionWiley2023info:eu-repo/semantics/articlee29240http://hdl.handle.net/20.500.12328/3877https://dx.doi.org/10.1002/jmv.29240reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésJournal of Medical Virology95;11© 2023 The Authors. Journal of Medical Virology published by Wiley Periodicals LLC. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.https://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:20.500.12328/38772026-05-29T05:05:01Z |
| 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, Adolfo Viruela del mono PCR Control de calidad Verola del mico PCR Control de qualitat Monkeypox PCR Quality control 61 |
| 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, Adolfo Martínez, Miguel J. Navero-Castillejos, Jessica Negredo, Anabel Galán, Juan Carlos Rojo Molinero, Estrella Lagarejos, Eduardo Muñoz-Almagro, Carmen Hernández Rodríguez, Águeda Lepe, José Antonio Antón Pagarolas, Andrés Pérez Castro, Sonia Zamora Cintas, María Isabel Domínguez-Gil González, Marta Niubó-Bosch, Jordi Gutiérrez Arroyo, Almudena Vazquez, Ana García, Federico Sánchez-Seco Fariñas, María Paz |
| author |
De Salazar, Adolfo |
| author_facet |
De Salazar, Adolfo Martínez, Miguel J. Navero-Castillejos, Jessica Negredo, Anabel Galán, Juan Carlos Rojo Molinero, Estrella Lagarejos, Eduardo Muñoz-Almagro, Carmen Hernández Rodríguez, Águeda Lepe, José Antonio Antón Pagarolas, Andrés Pérez Castro, Sonia Zamora Cintas, María Isabel Domínguez-Gil González, Marta Niubó-Bosch, Jordi Gutiérrez Arroyo, Almudena Vazquez, Ana García, Federico Sánchez-Seco Fariñas, María Paz |
| author_role |
author |
| author2 |
Martínez, Miguel J. Navero-Castillejos, Jessica Negredo, Anabel Galán, Juan Carlos Rojo Molinero, Estrella Lagarejos, Eduardo Muñoz-Almagro, Carmen Hernández Rodríguez, Águeda Lepe, José Antonio Antón Pagarolas, Andrés Pérez Castro, Sonia Zamora Cintas, María Isabel Domínguez-Gil González, Marta Niubó-Bosch, Jordi Gutiérrez Arroyo, Almudena Vazquez, Ana García, Federico Sánchez-Seco Fariñas, María Paz |
| 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 |
Viruela del mono PCR Control de calidad Verola del mico PCR Control de qualitat Monkeypox PCR Quality control 61 |
| topic |
Viruela del mono PCR Control de calidad Verola del mico PCR Control de qualitat Monkeypox PCR Quality control 61 |
| 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®). 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 Ct = 39. Conversely, one center, using the TaqMan™ 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 |
| format |
article |
| dc.identifier.none.fl_str_mv |
http://hdl.handle.net/20.500.12328/3877 https://dx.doi.org/10.1002/jmv.29240 |
| url |
http://hdl.handle.net/20.500.12328/3877 https://dx.doi.org/10.1002/jmv.29240 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.relation.none.fl_str_mv |
Journal of Medical Virology 95;11 |
| dc.rights.none.fl_str_mv |
https://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess |
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https://creativecommons.org/licenses/by-nc-nd/4.0/ |
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openAccess |
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e29240 |
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Wiley |
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Wiley |
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reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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