{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T11:40:47Z","timestamp":1788954047078,"version":"build-2803163510"},"reference-count":20,"publisher":"American Society for Microbiology","issue":"5","license":[{"start":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T00:00:00Z","timestamp":1715126400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T00:00:00Z","timestamp":1715126400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"name":"QIAGEN"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2024,5,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:sec>\n            <jats:title\/>\n            <jats:p>\n              The mpox outbreak, caused by monkeypox virus (MPXV), accelerated the development of molecular diagnostics. In this study, we detail the evaluation of the Research Use Only (RUO) NeuMoDx MPXV assay by multiple European and US sites. The assay was designed and developed by Qiagen for the NeuMoDx Molecular Systems. Primers and probes were tested for specificity and inclusivity\n              <jats:italic>in silico<\/jats:italic>\n              . The analytical sensitivity of the assay was determined by testing dilutions of synthetic and genomic MPXV DNA. A total of 296 clinical samples were tested by three sites; the Johns Hopkins University (US), UZ Gent (Belgium, Europe), and Hospital Universitario San Cecilio (Spain, Europe). The analytical sensitivity of the assay was 50 copies\/mL for both clades I and II. The assay showed 100%\n              <jats:italic>in silico<\/jats:italic>\n              identity for 80 clade I and 99.98%\n              <jats:italic>in silico<\/jats:italic>\n              identity for 5,162 clade II genomes. Clade II primers and probes showed 100%\n              <jats:italic>in silico<\/jats:italic>\n              specificity; however, identity of at least one of the two sets of clade I primers and probes with variola, cowpox, camelpox, and vaccinia viruses was noticed. The clinical validation showed sensitivity of 99.21% [95% confidence interval (CI): 95.66\u201399.98%] and specificity of 96.64% (95% CI: 91.62\u201399.08%) for lesion swab samples. The NeuMoDx MPXV Test shows acceptable analytical and clinical performance. The assay improves the laboratory\u2019s workflow as it consolidates nucleic acid extraction, PCR, data analysis, and interpretation and can be interfaced. The Test Strip can differentiate clades I and II, which has important laboratory safety implications.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>IMPORTANCE<\/jats:title>\n            <jats:p>\n              In this manuscript, we provide detailed\n              <jats:italic>in silico<\/jats:italic>\n              analysis and clinical evaluation of the assay using a large cohort of clinical samples across three academic centers in Europe and the United States. Because the assay differentiates MPXV clades I and II, this manuscript is timely due to the current need to rule out the regulated clade I by diagnostic clinical laboratories. In December 2023, and due to first report of cases of sexually transmitted clade I infections in the Democratic Republic of the Congo, when generic assays that do not differentiate the clades are used, samples are considered regulated. The assay meets the need of full automation and has a marked positive impact on the laboratory workflow.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1128\/jcm.00028-24","type":"journal-article","created":{"date-parts":[[2024,4,19]],"date-time":"2024-04-19T13:00:31Z","timestamp":1713531631000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":10,"title":["Multi-center evaluation of the Research Use Only NeuMoDx monkeypox virus (MPXV) fully automated real-time PCR assay"],"prefix":"10.1128","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0274-8966","authenticated-orcid":true,"given":"Heba H.","family":"Mostafa","sequence":"first","affiliation":[{"name":"Division of Medical Microbiology, Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gavin","family":"Wall","sequence":"additional","affiliation":[{"name":"QIAGEN GmbH, Hilden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Szu-Chi","family":"Su","sequence":"additional","affiliation":[{"name":"NeuMoDx Molecular Inc, a QIAGEN company, Ann Arbor, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerta","family":"Hysa","sequence":"additional","affiliation":[{"name":"NeuMoDx Molecular Inc, a QIAGEN company, Ann Arbor, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lijie","family":"Gong","sequence":"additional","affiliation":[{"name":"NeuMoDx Molecular Inc, a QIAGEN company, Ann Arbor, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Urbain Charly","family":"Dadjeu","sequence":"additional","affiliation":[{"name":"Division of Medical Microbiology, Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Cheung","sequence":"additional","affiliation":[{"name":"Division of Medical Microbiology, Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3248-1761","authenticated-orcid":true,"given":"Andrew","family":"Pekosz","sequence":"additional","affiliation":[{"name":"W. Harry Feinstone Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Delphine","family":"De Smet","sequence":"additional","affiliation":[{"name":"Universitair Ziekenhuis Gent, Gent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikola","family":"Sklenovsk\u00e1","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical and Epidemiological, Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute, KU Leuven, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lies","family":"Laenen","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium"},{"name":"Laboratory of Clinical Microbiology, Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Vi\u00f1uela","sequence":"additional","affiliation":[{"name":"Hospital Universitario Cl\u00ednico San Cecilio, Granada, Spain"},{"name":"Instituto de Investigaci\u00f3n Biosanitaria IBS.GRANADA, Granada, Spain"},{"name":"Ciber de Enfermedades Infecciosas, CIBERINFEC, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adolfo","family":"de Salazar","sequence":"additional","affiliation":[{"name":"Hospital Universitario Cl\u00ednico San Cecilio, Granada, Spain"},{"name":"Instituto de Investigaci\u00f3n Biosanitaria IBS.GRANADA, Granada, Spain"},{"name":"Ciber de Enfermedades Infecciosas, CIBERINFEC, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Fuentes","sequence":"additional","affiliation":[{"name":"Hospital Universitario Cl\u00ednico San Cecilio, Granada, Spain"},{"name":"Instituto de Investigaci\u00f3n Biosanitaria IBS.GRANADA, Granada, Spain"},{"name":"Ciber de Enfermedades Infecciosas, CIBERINFEC, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8101-6957","authenticated-orcid":false,"given":"Elizaveta","family":"Padalko","sequence":"additional","affiliation":[{"name":"Universitair Ziekenhuis Gent, Gent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7611-781X","authenticated-orcid":false,"given":"Federico","family":"Garcia","sequence":"additional","affiliation":[{"name":"Hospital Universitario Cl\u00ednico San Cecilio, Granada, Spain"},{"name":"Instituto de Investigaci\u00f3n Biosanitaria IBS.GRANADA, Granada, Spain"},{"name":"Ciber de Enfermedades Infecciosas, CIBERINFEC, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cit703"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF01254676"},{"key":"e_1_3_3_4_2","first-page":"593","article-title":"A human infection caused by monkeypox virus in Basankusu territory, Democratic Republic of the Congo","volume":"46","author":"Ladnyj ID","year":"1972","unstructured":"Ladnyj ID, Ziegler P, Kima E. 1972. A human infection caused by monkeypox virus in Basankusu territory, Democratic Republic of the Congo. Bull World Health Organ 46:593\u2013597.","journal-title":"Bull World Health Organ"},{"key":"e_1_3_3_5_2","first-page":"537","article-title":"Multistate outbreak of monkeypox--Illinois, Indiana, and Wisconsin, 2003","volume":"52","author":"Centers for Disease Control and Prevention (CDC)","year":"2003","unstructured":"Centers for Disease Control and Prevention (CDC). 2003. Multistate outbreak of monkeypox--Illinois, Indiana, and Wisconsin, 2003. MMWR Morb Mortal Wkly Rep 52:537\u2013540.","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0007791"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.3390\/v12111257"},{"key":"e_1_3_3_8_2","unstructured":"Centers for disease control and prevention. 2023. Available from: https:\/\/www.cdc.gov\/poxvirus\/mpox\/response\/2022\/index.html. 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Available from: https:\/\/www.cdc.gov\/poxvirus\/mpox\/lab-personnel\/lab-procedures.html"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm7136e1"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2022.105294"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.00028-24","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.00028-24","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T13:03:19Z","timestamp":1715173399000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/jcm.00028-24"}},"subtitle":[],"editor":[{"given":"Randall","family":"Hayden","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2024,5,8]]},"references-count":20,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,5,8]]}},"alternative-id":["10.1128\/jcm.00028-24"],"URL":"https:\/\/doi.org\/10.1128\/jcm.00028-24","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5,8]]},"assertion":[{"value":"2024-01-09","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-03-29","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-19","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00028-24"}}