{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T01:26:25Z","timestamp":1778808385768,"version":"3.51.4"},"reference-count":15,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2023,8,11]],"date-time":"2023-08-11T00:00:00Z","timestamp":1691712000000},"content-version":"vor","delay-in-days":10,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>While Mpox virus (MPXV) diagnostics were performed in specialized laboratories only, the global emergence of Mpox cases in 2022 revealed the need for a more readily available diagnostic. Automated random\u2010access platforms with fast nucleic acid extraction and PCR have become established in many laboratories, providing faster and more accessible testing. In this study, we adapted a previously published generic MPXV\u2010PCR as a lab\u2010developed test (LDT) on a NeuMoDx Molecular System and isolated MPXV clones from patient materials. To reduce the handling of infectious material, we evaluated a viral lysis buffer (VLB) for sample pretreatment. We further compared the MPXV\u2010LDT\u2010PCR to conventional real\u2010time PCR, determined its sensitivity and specificity using positive swabs, and assessed its performance using external quality assessment samples. Pretreatment of samples with 50% VLB reduced MPXV infectivity by approximately 200\u2010fold while maintaining PCR sensitivity. The assay demonstrated a sensitivity and specificity of 100% with no cross\u2010reactivity in the samples tested and performed with a limit of detection of 262 GE\/mL. In summary, the assay had a turnaround time of fewer than 2\u2009h and can easily be transferred to other automated PCR platforms, providing a basis for developing rapid assays for upcoming pandemics.<\/jats:p>","DOI":"10.1002\/jmv.29022","type":"journal-article","created":{"date-parts":[[2023,8,11]],"date-time":"2023-08-11T12:54:25Z","timestamp":1691758465000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Implementation and clinical evaluation of an Mpox virus laboratory\u2010developed test on a fully automated random\u2010access platform"],"prefix":"10.1002","volume":"95","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4101-9280","authenticated-orcid":false,"given":"Jochen M.","family":"Wettengel","sequence":"first","affiliation":[{"name":"School of Medicine, Institute of Virology Technical University of Munich Munich Germany"},{"name":"Helmholtz Munich, School of Medicine Institute of Virology Munich Germany"},{"name":"German Center for Infection Research (DZIF) Munich Partner Site Munich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2175-7008","authenticated-orcid":false,"given":"Till","family":"Bunse","sequence":"additional","affiliation":[{"name":"School of Medicine, Institute of Virology Technical University of Munich Munich Germany"},{"name":"Helmholtz Munich, School of Medicine Institute of Virology Munich Germany"},{"name":"German Center for Infection Research (DZIF) Munich Partner Site Munich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1948-2057","authenticated-orcid":false,"given":"Samuel D.","family":"Jeske","sequence":"additional","affiliation":[{"name":"School of Medicine, Institute of Virology Technical University of Munich Munich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roman","family":"W\u00f6lfel","sequence":"additional","affiliation":[{"name":"German Center for Infection Research (DZIF) Munich Partner Site Munich Germany"},{"name":"Bundeswehr, Institute of Microbiology Munich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabine","family":"Zange","sequence":"additional","affiliation":[{"name":"German Center for Infection Research (DZIF) Munich Partner Site Munich Germany"},{"name":"Bundeswehr, Institute of Microbiology Munich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julia","family":"Taeubner","sequence":"additional","affiliation":[{"name":"QIAGEN GmbH Strategic Lab Consultancy Hilden Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Uta","family":"Goelnitz","sequence":"additional","affiliation":[{"name":"QIAGEN GmbH Strategic Lab Consultancy Hilden Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ulrike","family":"Protzer","sequence":"additional","affiliation":[{"name":"School of Medicine, Institute of Virology Technical University of Munich Munich Germany"},{"name":"Helmholtz Munich, School of Medicine Institute of Virology Munich Germany"},{"name":"German Center for Infection Research (DZIF) Munich Partner Site Munich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,8,11]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/nature06536"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.3386\/w27840"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104583"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2021.104869"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2021.104946"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01187-20"},{"key":"e_1_2_9_8_1","unstructured":"World Health Organization. WHO coronavirus (COVID\u201019) dashboard. 2022. Accessed June 19 2023.https:\/\/covid19.who.int\/"},{"key":"e_1_2_9_9_1","unstructured":"Centers for Disease Control and Prevention. Monkeypox outbreak global map. 2022. 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