Evaluation of analytical performance of the STANDARD^TM M10 MPX/OPX assay for the simultaneous DNA detection and clade attribution of Monkeypox virus

References

• Petersen E, Kantele M, Koopmans D, et al. Human monkeypox: epidemiologic and clinical characteristics, diagnosis, and prevention. Infect Dis Clin North Am. 2019;33:1027–1043.
   PubMed Web of Science ®Google Scholar
• Likos AM, Sammons SA, Olson VA, et al. A tale of two clades: monkeypox viruses. J Gen Virol. 2005;86(Pt 10):2661–2672. doi:10.1099/vir.0.81215-0. PMID: 16186219.
   PubMed Web of Science ®Google Scholar
• Gessain A, Nakoune E, Yazdanpanah Y. Monkeypox. N Engl J Med. 2022;387(19):1783–1793. doi: 10.1056/NEJMra2208860. Epub 2022 Oct 26. PMID: 36286263.
   PubMed Web of Science ®Google Scholar
• Reynolds MG, Damon IK. Outbreaks of human monkeypox after cessation of smallpox vaccination. Trends Microbiol. 2012 Feb;20(2):80–87. doi:10.1016/j.tim.2011.12.001
   PubMed Web of Science ®Google Scholar
• McCollum AM, Damon IK. Human monkeypox. Clin Infect Dis. 2014 Jan;58(2):260–267. doi:10.1093/cid/cit703
   PubMed Web of Science ®Google Scholar
• Spickler AR. 2022 [cited 2022 Sep 19]. Available from: http://www.cfsph.iastate.edu/DiseaseInfo/factsheets.php.
   Google Scholar
• Curaudeau M, Besombes C, Nakouné E, et al. Identifying the most probable mammal reservoir hosts for monkeypox virus based on ecological niche comparisons. Viruses. 2023 Mar 11;15(3):727. doi:10.3390/v15030727
   PubMed Web of Science ®Google Scholar
• Monkeypox: background information. UK Health Security Agency, Public Health England; 2022.
   Google Scholar
• Brown K, Leggat PA. Human monkeypox: current state of knowledge and implications for the future. Trop Med Infect Dis. 2016 Dec 20;1(1):8. doi:10.3390/tropicalmed1010008. PMID: 30270859; PMCID: PMC6082047.
   PubMedGoogle Scholar
• World Health Organization. Multi-country Monkeypox outbreak in non-endemic countries; [cited 2023 May 2]. Available from: https://www.who.int/emergencies/disease-outbreak-news/item/2022-DON385.
   Google Scholar
• Ham SY, Jeong H, Jung J, et al. Performance of STANDARD™ M10 SARS-CoV-2 assay for the diagnosis of COVID-19 from a nasopharyngeal swab. Infect Chemother. 2022 Jun;54(2):360–363. doi:10.3947/ic.2022.0047. Epub 2022 May 13. PMID: 35706076; PMCID: PMC9259922.
   PubMed Web of Science ®Google Scholar
• Abdullah A, Sam IC, Ong YJ, et al. Comparative evaluation of a standard M10 assay with Xpert Xpress for the rapid molecular diagnosis of SARS-CoV-2, influenza A/B virus, and respiratory syncytial virus. Diagnostics (Basel). 2023 Nov 22;13(23):3507. doi:10.3390/diagnostics13233507. PMID: 38066748; PMCID: PMC10706428.
   PubMedGoogle Scholar
• Liao JJ. Sample size calculation for an agreement study. Pharm Stat. 2010;9(2):125–132. doi:10.1002/pst.382. PMID: 19507134
   PubMed Web of Science ®Google Scholar
• Kraemer MUG, Houriiyah T, Pigott DM, et al. Tracking the 2022 monkeypox outbreak with epidemiological data in real-time. Lancet Infect Dis. 2022; 22(7):941-942.doi:10.1016/S1473-3099(22)00359-0.
   PubMedGoogle Scholar
• Saied AA, Dhawan M, Metwally AA, et al. Disease history, pathogenesis, diagnostics, and therapeutics for human monkeypox disease: a comprehensive review. Vaccines. 2022;10(12):2091. doi:10.3390/vaccines10122091
   Web of Science ®Google Scholar
• Espy MJ, Cockerill III FR, Meyer RF, et al. Detection of smallpox virus DNA by LightCycler PCR. J Clin Microbiol. 2002;40(6):1985–1988. doi:10.1128/JCM.40.6.1985-1988.2002
   PubMed Web of Science ®Google Scholar
• Li Y, Zhao H, Wilkins K, et al. Real-time PCR assays for the specific detection of monkeypox virus West African and Congo Basin strain DNA. J Virol Methods. 2010;169(1):223–227. doi:10.1016/j.jviromet.2010.07.012. Epub 2010 Jul 17.
   PubMed Web of Science ®Google Scholar
• Maksyutov RA, Gavrilova EV, Shchelkunov SN. Species-specific differentiation of variola, monkeypox, and varicella-zoster viruses by multiplex real-time PCR assay. J Virol Methods. 2016;236:215–220. doi:10.1016/j.jviromet.2016.07.024. Epub 2016 Jul 28.
   PubMed Web of Science ®Google Scholar
• Ropp SL, Jin Q, Knight JC, et al. PCR strategy for identification and differentiation of smallpox and other orthopoxviruses. J Clin Microbiol. 1995;33(8):2069–2076. doi:10.1128/jcm.33.8.2069-2076.1995
   PubMed Web of Science ®Google Scholar
• Schroeder K, Nitsche A. Multicolour, multiplex real-time PCR assay for the detection of human-pathogenic poxviruses. Mol Cell Probes. 2010;24(2):110–113. doi:10.1016/j.mcp.2009.10.008. Epub 2009 Oct 29.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Laboratory testing for the monkeypox virus - Interim Guidance. 23 May 2022. License: CC BY-NC-SA 3.0 IGO; [cited 2023 May 15]. Available from: https://www.who.int/publications/i/item/WHO-MPX-laboratory-2022.1.
   Google Scholar
• Parakatselaki ME, Alexi G, Zafiropoulos A, et al. Evaluation of STANDARDTM M10 SARS-CoV-2 assay as a diagnostic tool for SARS-CoV-2 in nasopharyngeal or oropharyngeal swab samples. J Clin Virol Plus. 2023;3:100129. doi:10.1016/j.jcvp.2022.100129
   PubMedGoogle Scholar
• Elbaz M, Halutz O, Ali Y, et al. Diagnosis of monkeypox infection: validation of two diagnostic kits for viral detection using RT-PCR. J Virol Methods. 2023;312:114653. doi:10.1016/j.jviromet.2022.114653. Epub 2022 Nov 14. PMID: 36395919; PMCID: PMC9661602.
   PubMed Web of Science ®Google Scholar
• Paniz-Mondolfi A, Guerra S, Muñoz M, et al. Evaluation and validation of an RT-PCR assay for specific detection of monkeypox virus (MPXV). J Med Virol. 2022;95:e28247. doi:10.1002/jmv.28247
   PubMed Web of Science ®Google Scholar
• Cui X, Du B, Feng J, et al. Rapid detection of Mpox virus using recombinase aided amplification assay. Front Cell Infect Microbiol. 2023;13:1008783. doi:10.3389/fcimb.2023.1008783
   PubMed Web of Science ®Google Scholar
• World Health Organization. 2022-23 Mpox (monkeypox) outbreak: global trends; [cited 2023 June 29]. Available from: https://worldhealthorg.shinyapps.io/mpx_global/.
   Google Scholar
• Colagrossi L, Costabile V, Scutari R, et al. Performance evaluation of a new on-demand molecular test for the rapid identification of severe acute respiratory syndrome coronavirus 2 in pediatric and adult patients. Front Microbiol; 13:999783. doi:10.3389/fmicb.2022.999783
   PubMed Web of Science ®Google Scholar
• Domnich A, Orsi A, Trombetta CS, et al. Comparative diagnostic accuracy of the STANDARD M10 assay for the molecular diagnosis of SARS-CoV-2 in the point-of-care and critical care settings. J Clin Med. 2022;11:2465. doi:10.3390/jcm11092465
   PubMed Web of Science ®Google Scholar
• Domnich A, Bruzzone B, Trombetta CS, et al. Rapid differential diagnosis of SARS-CoV-2, influenza A/B and respiratory syncytial viruses: validation of a novel RT-PCR assay. J Clin Vir. 2023;161:105402. doi:10.1016/j.jcv.2023.105402
   PubMed Web of Science ®Google Scholar
• Jeong S, Lee N, Lee SK, et al. STANDARD m10 SARS-CoV-2 assay for rapid detection of SARS-CoV-2: comparison of four real-time PCR assays. Diagnostics (Basel). 2022;12(8):1998. doi:10.3390/diagnostics12081998. PMID: 36010348; PMCID: PMC9406901.
   PubMedGoogle Scholar
• Andreani J, Arnault J, Bou Khalil JY, et al. Atypical cowpox virus infection in smallpox-vaccinated patient, France. Emerg Infect Dis. 2019;25(2):212–219. doi:10.3201/eid2502.171433
   PubMed Web of Science ®Google Scholar
• Diaz JH. The disease ecology, epidemiology, clinical manifestations, management, prevention, and control of increasing human infections with animal orthopoxviruses. Wilderness Environ Med. 2021;32(4):528–536. doi:10.1016/j.wem.2021.08.003
   PubMed Web of Science ®Google Scholar
• Eltom KH, Samy AM, Abd El Wahed A, et al. Buffalopox virus: an emerging virus in livestock and humans. Pathogens. 2020;9(9):676. doi:10.3390/pathogens9090676
   PubMed Web of Science ®Google Scholar
• Kiernan M, Koutroumanos N. Orbital cowpox. N Engl J Med. 2021;384(23):2241. doi:10.1056/NEJMicm2033620
   PubMed Web of Science ®Google Scholar
• Kibungu EM, Vakaniaki EH, Kinganda-Lusamaki E, et al. Clade I–associated Mpox cases associated with sexual contact, the Democratic Republic of the Congo. Emerg Infect Dis. 2024;30(1):172–176. doi:10.3201/eid3001.231164
   PubMed Web of Science ®Google Scholar
• World Health Organization. Disease outbreak news: Mpox (monkeypox)- democratic republic of the Congo; [cited 2023 Jan 15]. Available from: https://www.who.int/emergencies/disease-outbreak-news/item/2023-DON493.
   Google Scholar