The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control
Autor/a
De Salazar, Adolfo
Martínez, Miguel J.
Navero-Castillejos, Jessica
Negredo, Anabel
Galán, Juan Carlos
Rojo Molinero, Estrella
Lagarejos, Eduardo
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
Fecha de publicación
2023ISSN
0146-6615
Resumen
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.
Tipo de documento
Artículo
Versión del documento
Versión publicada
Lengua
English
Materias (CDU)
61 - Medicina
Palabras clave
Viruela del mono
PCR
Control de calidad
Verola del mico
PCR
Control de qualitat
Monkeypox
PCR
Quality control
Páginas
e29240
Publicado por
Wiley
Colección
95; 11
Publicado en
Journal of Medical Virology
Citación
De Salazar, Adolfo; Martínez, Miguel J; Navero-Castillejos, Jessica [et al.]. The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control. Journal of Medical Virology, 2023, 95(11), e29240. Disponible en: <https://onlinelibrary.wiley.com/doi/10.1002/jmv.29240>. Fecha de acceso: 19 dic. 2023. DOI: 10.1002/jmv.29240
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Derechos
© 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.
Excepto si se señala otra cosa, la licencia del ítem se describe como https://creativecommons.org/licenses/by-nc-nd/4.0/