{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T17:19:19Z","timestamp":1770743959069,"version":"3.49.0"},"reference-count":14,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2023,8,17]],"date-time":"2023-08-17T00:00:00Z","timestamp":1692230400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,8,17]],"date-time":"2023-08-17T00:00:00Z","timestamp":1692230400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Virus Genes"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Mpox is a viral zoonosis with endemic circulation in animals and humans in some West and Central African countries. The disease was imported a few times in the past to countries outside the African continent through infected animals or travelers, one of which resulted in an unprecedented global outbreak sustained by human-to-human transmission in 2022. Although timely and reliable diagnosis is a cornerstone of any disease control, availability of accurate diagnostic assays and comparative performance studies of diagnostic assays remains limited despite of the long-known identification of monkeypox virus (MPXV) as a human pathogen since 1970. We laboratory-developed a real-time PCR test (LDT) and evaluated its performance against the commercial TaqMan\u2122 Monkeypox Virus Microbe Detection Assay (Applied Biosystems, Cat A50137). The limit of detection of the LDT was established at 1.2 genome copies\/ml. The sensitivity and specificity of both assays were 99.14% and 100%, respectively, and both are capable of detecting both clade I and clade II of MPXV. Our results demonstrate the validity and accuracy of the LDT for confirmation of MPXV infection from lesion swabs samples.<\/jats:p>","DOI":"10.1007\/s11262-023-02024-9","type":"journal-article","created":{"date-parts":[[2023,8,17]],"date-time":"2023-08-17T09:02:36Z","timestamp":1692262956000},"page":"795-800","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Design and validation of a laboratory-developed diagnostic assay for monkeypox virus"],"prefix":"10.1007","volume":"59","author":[{"given":"Nikola","family":"Sklenovsk\u00e1","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mandy","family":"Bloemen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valentijn","family":"Vergote","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne-Sophie","family":"Logist","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bert","family":"Vanmechelen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lies","family":"Laenen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emmanuel","family":"Andr\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean-Jacques","family":"Muyembe-Tamfum","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elke","family":"Wollants","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc","family":"Van Ranst","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Piet","family":"Maes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tony","family":"Wawina-Bokalanga","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,8,17]]},"reference":[{"key":"2024_CR1","unstructured":"Multi-country outbreak of monkeypox, external situation report #8\u201319 October 2022. https:\/\/www.who.int\/publications\/m\/item\/multi-country-outbreak-of-monkeypox--external-situation-report--8---19-october-2022. Accessed 28 Oct 2022"},{"key":"2024_CR2","first-page":"297","volume":"45","author":"Z Jezek","year":"1988","unstructured":"Jezek Z, Szczeniowski M, Paluku KM, Mutombo M, Grab B (1988) Human monkeypox: confusion with chickenpox. Acta Trop 45:297\u2013307","journal-title":"Acta Trop"},{"key":"2024_CR3","doi-asserted-by":"publisher","first-page":"58","DOI":"10.1016\/j.ijid.2022.12.014","volume":"128","author":"A Wieder-Feinsod","year":"2023","unstructured":"Wieder-Feinsod A, Zilberman T, Erster O, Kolasko GW, Biber A, Gophen R, Hoffman T, Litchevsky V, Olmer L, Yahav D et al (2023) Overlooked monkeypox cases among men having sex with men during the 2022 Outbreak\u2014a retrospective study. Int J Infect Dis 128:58\u201360. https:\/\/doi.org\/10.1016\/j.ijid.2022.12.014","journal-title":"Int J Infect Dis"},{"key":"2024_CR4","unstructured":"Surveillance, case investigation and contact tracing for monkeypox: interim guidance. https:\/\/www.who.int\/publications-detail-redirect\/WHO-MPX-Surveillance-2022.3. Accessed 5 Oct 2022"},{"key":"2024_CR5","unstructured":"Monkeypox Fact Sheet. https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/monkeypox. Accessed 26 Feb 2023"},{"key":"2024_CR6","doi-asserted-by":"publisher","first-page":"2200816","DOI":"10.2807\/1560-7917.ES.2022.27.45.2200816","volume":"27","author":"J Michel","year":"2022","unstructured":"Michel J, Targosz A, Rinner T, Bourquain D, Brinkmann A, Sacks JA, Schaade L, Nitsche A (2022) Evaluation of 11 commercially available PCR Kits for the detection of monkeypox virus DNA, Berlin, July to September 2022. Euro Surveill 27:2200816. https:\/\/doi.org\/10.2807\/1560-7917.ES.2022.27.45.2200816","journal-title":"Euro Surveill"},{"key":"2024_CR7","unstructured":"Monkeypox test directory. https:\/\/www.finddx.org\/tools-and-resources\/dxconnect\/test-directories\/monkeypox-test-directory\/. Accessed 1 Feb 2023"},{"key":"2024_CR8","doi-asserted-by":"crossref","unstructured":"Kumar S, Stecher G, Tamura K (2015) MEGA7: molecular evolutionary genetics analysis version 7.0","DOI":"10.1093\/molbev\/msw054"},{"key":"2024_CR9","unstructured":"Integrated DNA Technologies. PrimerQuest tool. https:\/\/Eu.Idtdna.Com\/Primerquest\/Home\/Index. Accessed 30 Jan 2023"},{"key":"2024_CR10","doi-asserted-by":"publisher","first-page":"W43","DOI":"10.1093\/Nar\/Gkm234","volume":"35","author":"WA Kibbe","year":"2007","unstructured":"Kibbe WA (2007) OligoCalc: an online oligonucleotide properties calculator. Nucleic Acids Res 35:W43\u2013W46. https:\/\/doi.org\/10.1093\/Nar\/Gkm234","journal-title":"Nucleic Acids Res"},{"key":"2024_CR11","unstructured":"Thermo fisher scientific taqman monkeypox virus microbe detection assay user guide (Pub. No. MAN0028079 A.0) 2022"},{"key":"2024_CR12","unstructured":"Lab alert: MPXV TNF receptor gene deletion may lead to false negative results with some MPXV specific LDTs. https:\/\/www.cdc.gov\/locs\/2022\/09-02-2022-lab-alert-MPXV_TNF_Receptor_Gene_Deletion_May_Lead_False_Negative_Results_Some_MPXV_Specific_LDTs.html. Accessed 30 Jan 2023"},{"key":"2024_CR13","doi-asserted-by":"publisher","unstructured":"A multi-laboratory evaluation of commercial monkeypox molecular tests. MedRxiv. https:\/\/doi.org\/10.1101\/2022.11.27.22282791v1","DOI":"10.1101\/2022.11.27.22282791v1"},{"key":"2024_CR14","doi-asserted-by":"publisher","first-page":"392","DOI":"10.1016\/j.bsheal.2022.10.005","volume":"4","author":"S Huo","year":"2022","unstructured":"Huo S, Chen Y, Lu R, Zhang Z, Zhang G, Zhao L, Deng Y, Wu C, Tan W (2022) Development of two multiplex real-time PCR assays for simultaneous detection and differentiation of monkeypox virus IIa, IIb, and I clades and the B.1 lineage. 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