{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,15]],"date-time":"2026-08-15T00:54:01Z","timestamp":1786755241222,"version":"build-2736575974"},"reference-count":22,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T00:00:00Z","timestamp":1711497600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Microorganisms"],"abstract":"<jats:p>In 2022\u201323, the human monkeypox virus (MPXV) caused a global outbreak in several non-endemic countries. Here, we evaluated the diagnostic performance of four real-time qualitative PCR assays for the laboratory diagnosis of mpox (monkeypox) monkeypox disease. From July to August 2022, 27 positive and 10 negative specimens (lesion, crust and exudate swabs) were tested in the laboratory of the Hygiene Unit of the San Martino Hospital (Genoa, Italy) by using home-made real-time PCR to detect MPXV generic G2R_G DNA. According to the manufacturer\u2019s instructions, we also retrospectively analyzed these specimens using RealCycler MONK-UX\/-GX (Progenie Molecular), STANDARD M10 MPX\/OPX (SD Biosensor), Novaplex MPXV (Seegene Inc.) and RealStar Orthopoxvirus PCR Kit 1.0 (Altona Diagnostics) assays, recognized as research-use-only tests. The diagnostic accuracy and sensitivity of these assays ranged from 97.3% (95% CI: 86.2\u201399.5%) to 100% (95% CI: 90.6\u2013100%) and 96.3% (95% CI: 81.72\u201399.34%) to 100% (95% CI: 72.2\u2013100%), respectively. The RealCycler MONK-UX and STANDARD M10 MPX\/OPX did not detect one positive sample with a cycle threshold of 36. The overall specificity was 100% (95% CI: 72.2\u2013100%), and Cohen\u2019s Kappa values ranged from 1 (95% CI: 0.67\u20131) to 0.93 (95% CI: 0.61\u20131). As they are highly accurate, reliable and user-friendly, these tests should be recommended for the routine or rapid laboratory discrimination of mpox from other rash illnesses.<\/jats:p>","DOI":"10.3390\/microorganisms12040664","type":"journal-article","created":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T14:14:09Z","timestamp":1711548849000},"page":"664","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Molecular Diagnosis of Human Monkeypox Virus during 2022\u201323 Outbreak: Preliminary Evaluation of Novel Real-Time Qualitative PCR Assays"],"prefix":"10.3390","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9822-6520","authenticated-orcid":false,"given":"Vanessa","family":"De Pace","sequence":"first","affiliation":[{"name":"Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy"},{"name":"Laboratorio di Riferimento Regionale per le Emergenze di Sanit\u00e0 Pubblica (LaRESP), 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bianca","family":"Bruzzone","sequence":"additional","affiliation":[{"name":"Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy"},{"name":"Laboratorio di Riferimento Regionale per le Emergenze di Sanit\u00e0 Pubblica (LaRESP), 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Ricucci","sequence":"additional","affiliation":[{"name":"Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy"},{"name":"Laboratorio di Riferimento Regionale per le Emergenze di Sanit\u00e0 Pubblica (LaRESP), 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9608-8892","authenticated-orcid":false,"given":"Alexander","family":"Domnich","sequence":"additional","affiliation":[{"name":"Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy"},{"name":"Laboratorio di Riferimento Regionale per le Emergenze di Sanit\u00e0 Pubblica (LaRESP), 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4274-0096","authenticated-orcid":false,"given":"Giulia","family":"Guarona","sequence":"additional","affiliation":[{"name":"Laboratorio di Riferimento Regionale per le Emergenze di Sanit\u00e0 Pubblica (LaRESP), 16132 Genoa, Italy"},{"name":"Department of Health Sciences, University of Genoa, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giada","family":"Garzillo","sequence":"additional","affiliation":[{"name":"Laboratorio di Riferimento Regionale per le Emergenze di Sanit\u00e0 Pubblica (LaRESP), 16132 Genoa, Italy"},{"name":"Department of Health Sciences, University of Genoa, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rexhina","family":"Qosja","sequence":"additional","affiliation":[{"name":"Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy"},{"name":"Laboratorio di Riferimento Regionale per le Emergenze di Sanit\u00e0 Pubblica (LaRESP), 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8363-0195","authenticated-orcid":false,"given":"Giulia","family":"Ciccarese","sequence":"additional","affiliation":[{"name":"Dermatology Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1436-5089","authenticated-orcid":false,"given":"Antonio","family":"Di Biagio","sequence":"additional","affiliation":[{"name":"Infectious Disease Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2433-9610","authenticated-orcid":false,"given":"Andrea","family":"Orsi","sequence":"additional","affiliation":[{"name":"Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy"},{"name":"Laboratorio di Riferimento Regionale per le Emergenze di Sanit\u00e0 Pubblica (LaRESP), 16132 Genoa, Italy"},{"name":"Department of Health Sciences, University of Genoa, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8463-8487","authenticated-orcid":false,"given":"Giancarlo","family":"Icardi","sequence":"additional","affiliation":[{"name":"Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy"},{"name":"Laboratorio di Riferimento Regionale per le Emergenze di Sanit\u00e0 Pubblica (LaRESP), 16132 Genoa, Italy"},{"name":"Department of Health Sciences, University of Genoa, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,3,27]]},"reference":[{"key":"ref_1","unstructured":"World Health Organization (2024, March 09). 2022\u201323 Mpox (Monkeypox) Outbreak: Global Trends. 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