{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T23:18:21Z","timestamp":1783725501234,"version":"3.55.0"},"reference-count":13,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,11,16]],"date-time":"2023-11-16T00:00:00Z","timestamp":1700092800000},"content-version":"vor","delay-in-days":15,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>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\u00ae). Of the 12 centers conducting Mpox determinations, concordance ranged from 62.5% (<jats:italic>n<\/jats:italic>\u2009=\u20091) to 100% (<jats:italic>n<\/jats:italic>\u2009=\u200911) for eluates and from 75.0% (<jats:italic>n<\/jats:italic>\u2009=\u20091) to 100% (<jats:italic>n<\/jats:italic>\u2009=\u200910) for serum. Among the 10 centers performing Orthopoxvirus determinations, a 100% concordance was observed for eluates, while for serum, concordance ranged from 87.5% (<jats:italic>n<\/jats:italic>\u2009=\u20096) to 100% (<jats:italic>n<\/jats:italic>\u2009=\u20094). Repeatedly, 6 different centers reported a false negative in serum samples for Orthopoxvirus diagnosis, particularly in a sample with borderline <jats:italic>C<\/jats:italic><jats:sub>t<\/jats:sub>\u2009=\u200939. Conversely, one center, using the TaqMan\u2122 Mpox Virus Microbe Detection Assay (Thermo Fisher), reported false positives in Mpox diagnosis for samples spiked with vaccinia virus due to cross\u2010reactions. 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.<\/jats:p>","DOI":"10.1002\/jmv.29240","type":"journal-article","created":{"date-parts":[[2023,11,16]],"date-time":"2023-11-16T16:29:44Z","timestamp":1700152184000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control"],"prefix":"10.1002","volume":"95","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4318-858X","authenticated-orcid":false,"given":"Adolfo","family":"de Salazar","sequence":"first","affiliation":[{"name":"Servicio de Microbiolog\u00eda Hospital Universitario San Cecilio Granada Spain"},{"name":"Instituto de Investigaci\u00f3n Biosanitaria Ibs.Granada Granada Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas (CIBERINFEC) Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel J.","family":"Mart\u00ednez","sequence":"additional","affiliation":[{"name":"Servicio de Microbiolog\u00eda Hospital Clinic de Barcelona  Spain"},{"name":"Instituto de Salud Global de Barcelona (ISGloba) Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Navero\u2010Castillejos","sequence":"additional","affiliation":[{"name":"Servicio de Microbiolog\u00eda Hospital Clinic de Barcelona  Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anabel","family":"Negredo","sequence":"additional","affiliation":[{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas (CIBERINFEC) Madrid Spain"},{"name":"Centro Nacional de Microbiolog\u00eda Instituto de Salud Carlos III, Majadahonda Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Carlos","family":"Gal\u00e1n","sequence":"additional","affiliation":[{"name":"Servicio de Microbiolog\u00eda, Hospital Universitario Ram\u00f3n y Cajal Instituto Ram\u00f3n y Cajal de Investigaci\u00f3n Sanitaria (IRYCIS) Madrid Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red en Epidemiolog\u00eda y Salud P\u00fablica (CIBERESP) Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Estrella","family":"Rojo Molinero","sequence":"additional","affiliation":[{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas (CIBERINFEC) Madrid Spain"},{"name":"Departamento de Microbiolog\u00eda, Hospital Universitario Son Espases Health Research Institute of Balearic Islands (IdISBa) Palma Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eduardo","family":"Lagarejos","sequence":"additional","affiliation":[{"name":"Servicio de Microbiolog\u00eda Hospital Universitario de Gran Canaria Dr. Negr\u00edn, Las Palmas de Gran Canaria  Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen","family":"Mu\u00f1oz\u2010Almagro","sequence":"additional","affiliation":[{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red en Epidemiolog\u00eda y Salud P\u00fablica (CIBERESP) Madrid Spain"},{"name":"RDI Microbiology Department Hospital Sant Joan de Deu Barcelona Spain"},{"name":"Departamento de Medicina, School of Medicine Universitat Internacional de Catalunya Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c1gueda","family":"Hern\u00e1ndez Rodr\u00edguez","sequence":"additional","affiliation":[{"name":"Laboratori Cl\u00ednic de la Metropolitana Nord, Servei de Microbiologia Hospital Universitari Germans Trias i Pujol Badalona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 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L'Hospitalet de Llobregat Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Almudena","family":"Guti\u00e9rrez Arroyo","sequence":"additional","affiliation":[{"name":"Servicio de Microbiolog\u00eda Cl\u00ednica Hospital Universitario La Paz Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Vazquez","sequence":"additional","affiliation":[{"name":"Centro Nacional de Microbiolog\u00eda Instituto de Salud Carlos III, Majadahonda Madrid Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red en Epidemiolog\u00eda y Salud P\u00fablica (CIBERESP) Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7611-781X","authenticated-orcid":false,"given":"Federico","family":"Garc\u00eda","sequence":"additional","affiliation":[{"name":"Servicio de Microbiolog\u00eda Hospital Universitario San Cecilio Granada Spain"},{"name":"Instituto de Investigaci\u00f3n 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