{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T22:44:34Z","timestamp":1786574674895,"version":"build-2736575974"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,8,5]],"date-time":"2024-08-05T00:00:00Z","timestamp":1722816000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,8,5]],"date-time":"2024-08-05T00:00:00Z","timestamp":1722816000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100005713","name":"Technische Universit\u00e4t M\u00fcnchen","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100005713","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Med Microbiol Immunol"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Outbreaks of emerging diseases, like Mpox in 2022, pose unprecedented challenges to global healthcare systems. Although Mpox cases globally decreased since the end of 2022, numbers are still significant in the African Region, European Region, Region of the Americas, and Western Pacific Region. Rapid and efficient detection of infected individuals by precise screening assays is crucial for successful containment. In these assays, analytical and clinical performance must be assessed to ensure high quality. However, clinical studies evaluating Mpox virus (MPXV) detection kits using patient-derived samples are scarce. This study evaluated the analytical and clinical performance of a new diagnostic MPXV real-time PCR detection kit (Sansure Monkeypox Virus Nucleic Acid Diagnostic Kit) using patient-derived samples collected in Germany during the MPXV clade IIb outbreak in 2022. Our experimental approach determined the Limit of Detection (LoD) to less than 200 cp\/mL using whole blood samples and samples derived from vesicles or pustules. Furthermore, we tested potentially inhibiting substances and pathogens with homologous nucleic acid sequences or similar clinical presentation and detected no cross-reactivity or interference. Following this, the assay was compared to a CE-marked test in a clinical performance study and achieved a diagnostic sensitivity of 100.00% and diagnostic specificity of 96.97%. In summary, the investigated real-time PCR assay demonstrates high analytical performance and concurs with the competitor device with high specificity and sensitivity.<\/jats:p>","DOI":"10.1007\/s00430-024-00800-4","type":"journal-article","created":{"date-parts":[[2024,8,5]],"date-time":"2024-08-05T12:05:02Z","timestamp":1722859502000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Analytical and clinical evaluation of a novel real-time PCR-based detection kit for Mpox virus"],"prefix":"10.1007","volume":"213","author":[{"given":"Till","family":"Bunse","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Ziel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philipp","family":"Hagen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George","family":"Rigopoulos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Umit","family":"Yasar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hakan","family":"Inan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gurbet","family":"K\u00f6se","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrich","family":"Eigner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rolf","family":"Kaiser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nils","family":"Bardeck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jasmin","family":"K\u00f6ffer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"Kolb","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaomei","family":"Ren","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deyong","family":"Tan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lizhong","family":"Dai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrike","family":"Protzer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jochen M.","family":"Wettengel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,8,5]]},"reference":[{"issue":"4","key":"800_CR1","doi-asserted-by":"publisher","first-page":"e277","DOI":"10.1016\/S2666-5247(23)00034-4","volume":"4","author":"A Beeson","year":"2023","unstructured":"Beeson A et al (2023) Mpox respiratory transmission: the state of the evidence. Lancet Microbe 4(4):e277\u2013e283","journal-title":"Lancet Microbe"},{"issue":"1","key":"800_CR2","doi-asserted-by":"publisher","first-page":"e27931","DOI":"10.1002\/jmv.27931","volume":"95","author":"NL Bragazzi","year":"2023","unstructured":"Bragazzi NL et al (2023) Epidemiological trends and clinical features of the ongoing monkeypox epidemic: a preliminary pooled data analysis and literature review. J Med Virol 95(1):e27931","journal-title":"J Med Virol"},{"key":"800_CR3","unstructured":"Mathieu E et al Mpox (monkeypox). Our World in Data 2022; https:\/\/ourworldindata.org\/monkeypox"},{"key":"800_CR4","unstructured":"WHO. 2022-23 Mpox Outbreak: Global Trends (2023) ; https:\/\/worldhealthorg.shinyapps.io\/mpx_global\/"},{"key":"800_CR5","doi-asserted-by":"publisher","first-page":"105424","DOI":"10.1016\/j.jcv.2023.105424","volume":"161","author":"G Papadakis","year":"2023","unstructured":"Papadakis G et al (2023) Evaluation of 16 molecular assays for the detection of orthopox and mpox viruses. J Clin Virol 161:105424","journal-title":"J Clin Virol"},{"issue":"8","key":"800_CR6","doi-asserted-by":"publisher","first-page":"221","DOI":"10.1007\/s00705-023-05848-w","volume":"168","author":"Y Zhou","year":"2023","unstructured":"Zhou Y, Chen Z (2023) Mpox: a review of laboratory detection techniques. Arch Virol 168(8):221","journal-title":"Arch Virol"},{"issue":"8","key":"800_CR7","doi-asserted-by":"publisher","first-page":"e29022","DOI":"10.1002\/jmv.29022","volume":"95","author":"JM Wettengel","year":"2023","unstructured":"Wettengel JM et al (2023) Implementation and clinical evaluation of an Mpox virus laboratory-developed test on a fully automated random-access platform. J Med Virol 95(8):e29022","journal-title":"J Med Virol"},{"issue":"7","key":"800_CR8","doi-asserted-by":"publisher","first-page":"1333","DOI":"10.1007\/s00216-023-04518-9","volume":"415","author":"J Yang","year":"2023","unstructured":"Yang J et al (2023) Development of highly accurate digital PCR method and reference material for monkeypox virus detection. 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Euro Surveill, 27(45)","DOI":"10.2807\/1560-7917.ES.2022.27.45.2200816"},{"key":"800_CR17","unstructured":"Union E, Amtsblatt L 2017:117:TOC. 2017 [cited 2023 14.10.2023]; https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/?uri=OJ:L:2017:117:TOC"},{"key":"800_CR18","unstructured":"Organization WH (2022) -23 Mpox (Monkeypox) Outbreak: Global Trends. 2023 [cited 2023 14.10.2023]; https:\/\/worldhealthorg.shinyapps.io\/mpx_global\/"},{"issue":"1","key":"800_CR19","doi-asserted-by":"publisher","first-page":"90","DOI":"10.1186\/s12985-023-02059-2","volume":"20","author":"MS Bosmeny","year":"2023","unstructured":"Bosmeny MS et al (2023) Global mpox lineage discovery and rapid outbreak tracking with nanopore sequencing. Virol J 20(1):90","journal-title":"Virol J"}],"container-title":["Medical Microbiology and Immunology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00430-024-00800-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00430-024-00800-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00430-024-00800-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,12,26]],"date-time":"2024-12-26T08:06:15Z","timestamp":1735200375000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00430-024-00800-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8,5]]},"references-count":19,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["800"],"URL":"https:\/\/doi.org\/10.1007\/s00430-024-00800-4","relation":{},"ISSN":["0300-8584","1432-1831"],"issn-type":[{"value":"0300-8584","type":"print"},{"value":"1432-1831","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8,5]]},"assertion":[{"value":"17 November 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 July 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 August 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"For samples provided by the University of Cologne, broad consent for further use in research, including transfer to other centers and publication, was obtained in the context of a biobanking project (Ref. No. 13\u2013364) at the time of sample collection. For samples provided by the Technical University of Munich, informed consent for the use of left-over samples was waived due to the use of anonymized samples, not conducting any analyses that could be of individual relevance to the patients or their family members and not transferring samples to third parties.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"This study was sponsored by the National Genetic Detection Technology Application Demonstration Center, Changsha, People\u2019s Republic of China, which is part of Sansure Biotech Inc. The authors D.T., L.D., and X.R. are affiliated with the National Genetic Detection Technology Application Demonstration Center, Changsha, People\u2019s Republic of China. The authors A.Z., U.Y., H.I., and G.K. are affiliated with Requalite GmbH, who acted as a CRO on behalf of the sponsor and contributed to the study design. The sponsor agreed with the publication of the study\u2019s results.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was sponsored by the National Genetic Detection Technology Application Demonstration Center, Changsha, People\u2019s Republic of China, which is part of Sansure Biotech Inc. The authors D.T., L.D., and X.R. are affiliated with the National Genetic Detection Technology Application Demonstration Center, Changsha, People\u2019s Republic of China. The authors A.Z., U.Y., H.I., and G.K. are affiliated with Requalite GmbH, who acted as a CRO on behalf of the sponsor and contributed to the study design. The sponsor agreed with the publication of the study\u2019s results.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"18"}}