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00925njm 22002777a 4500 dc de Salazar, Adolfo author Martínez, Miguel J author Navero-Castillejos, Jessica author Negredo, Anabel author Galán, Juan Carlos author Rojo Molinero, Estrella author Lagarejos, Eduardo author Muñoz-Almagro, Carmen author Hernández Rodríguez, Águeda author Lepe, José Antonio author Antón Pagarolas, Andrés author Pérez Castro, Sonia author Zamora Cintas, María Isabel author Domínguez-Gil González, Marta author Niubó-Bosch, Jordi author Gutiérrez Arroyo, Almudena author Vazquez, Ana author García, Federico author Sánchez-Seco, María Paz author 2023-11 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. J Med Virol. 2023 Nov;95(11):e29240. 10.1002/jmv.29240 1096-9071 Journal of medical virology 37971716 http://hdl.handle.net/20.500.12105/18974 Monkeypox PCR Quality control The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control