{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T13:59:42Z","timestamp":1793109582067,"version":"4.5.0"},"reference-count":32,"publisher":"Public Library of Science (PLoS)","issue":"4","license":[{"start":{"date-parts":[[2025,4,1]],"date-time":"2025-04-01T00:00:00Z","timestamp":1743465600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Seegene"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background\/Objectives<\/jats:title>\n<jats:p>Human papillomavirus (HPV) genotyping is essential for cervical cancer screening and prevention. The Allplex<jats:sup>TM<\/jats:sup> HPV28 real-time PCR kit, using different chemistry and results analysis compared with its predecessor, the Anyplex<jats:sup>TM<\/jats:sup> II HPV28 kit, has recently been launched. This study aims to compare the Allplex<jats:sup>TM<\/jats:sup> HPV28 and Anyplex<jats:sup>TM<\/jats:sup> II HPV28 assays in detecting and genotyping the 13 high-risk (HR)-HPV types.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Study design<\/jats:title>\n<jats:p>Between 2022 and 2023, 459 cervical samples from women undergoing cervical cancer screening were selected. These samples were analysed by liquid-based cytology and tested by both kits concurrently.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>Allplex<jats:sup>TM<\/jats:sup> HPV28 Ct values correlated well with Anyplex<jats:sup>TM<\/jats:sup> II HPV28 signal intensity scores. No significant differences between assays were observed in overall and genotype-specific HR-HPV prevalence determined in all samples and according to cytological results. In addition, no significant differences were identified between assays in the detection of single and multiple HR-HPV infections. Most of the discordant results corresponded to samples showing weak HR-HPV signals and multiple HR-HPV types.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>Our results demonstrate that the Allplex<jats:sup>TM<\/jats:sup> HPV28 kit can be used for HPV genotyping, with results overall similar to those obtained with the Anyplex<jats:sup>TM<\/jats:sup> II HPV28 kit and the addition of Ct values for patient follow-up. The clinical implications of the potentially reduced sensitivity of the Allplex<jats:sup>TM<\/jats:sup> HPV28 kit in detecting HPV31 (<jats:italic>p<\/jats:italic> =\u2009 0.07) and HPV39 (<jats:italic>p<\/jats:italic> =\u2009 0.08) warrant further investigation in subsequent studies.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0320978","type":"journal-article","created":{"date-parts":[[2025,4,1]],"date-time":"2025-04-01T21:27:31Z","timestamp":1743542851000},"page":"e0320978","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":10,"title":["Comparative evaluation of Allplex HPV28 and Anyplex II HPV28 assays for high-risk HPV genotyping in cervical samples"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-0993-6432","authenticated-orcid":true,"given":"Sarah","family":"Mafi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flavie","family":"Theuillon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7957-6093","authenticated-orcid":true,"given":"Sylvain","family":"Meyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Baptiste","family":"Woillard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8703-7145","authenticated-orcid":true,"given":"Marine","family":"Dupont","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvie","family":"Rogez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Alain","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00e9bastien","family":"Hantz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,4,1]]},"reference":[{"issue":"3","key":"pone.0320978.ref001","first-page":"229","article-title":"Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries","volume":"74","author":"F Bray","year":"2024","journal-title":"CA: A Cancer Journal for Clinicians"},{"issue":"1","key":"pone.0320978.ref002","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1128\/CMR.16.1.1-17.2003","article-title":"Human papillomavirus and cervical cancer","volume":"16","author":"EM Burd","year":"2003","journal-title":"Clin Microbiol Rev"},{"key":"pone.0320978.ref003","volume-title":"Human papillomavirus. Chapter 11. In: Pink Book: Communicable Disease Control: A Guide for Public Health. Centers for Disease Control and Prevention; 2024 [Internet]. [cited October 22, 2024]","author":"E Meites"},{"key":"pone.0320978.ref004","first-page":"1","article-title":"Cervical cancer screening","volume":"18","author":"IARC","year":"2022","journal-title":"IARC Handb Cancer Prev"},{"issue":"4","key":"pone.0320978.ref005","doi-asserted-by":"crossref","first-page":"664","DOI":"10.1002\/ijc.30716","article-title":"Worldwide burden of cancer attributable to HPV by site, country and HPV type","volume":"141","author":"C de Martel","year":"2017","journal-title":"International Journal of Cancer"},{"issue":"3","key":"pone.0320978.ref006","doi-asserted-by":"crossref","first-page":"621","DOI":"10.1002\/ijc.22527","article-title":"Human papillomavirus type distribution in invasive cervical cancer and high-grade cervical lesions: a meta-analysis update","volume":"121","author":"JS Smith","year":"2007","journal-title":"Int J Cancer"},{"issue":"4","key":"pone.0320978.ref007","doi-asserted-by":"crossref","first-page":"550","DOI":"10.1002\/jmv.1085","article-title":"Detection of multiple human papillomavirus types in the lower genital tract correlates with cervical dysplasia","volume":"64","author":"KH Fife","year":"2001","journal-title":"J Med Virol"},{"issue":"2","key":"pone.0320978.ref008","doi-asserted-by":"crossref","first-page":"158","DOI":"10.1093\/aje\/kwf013","article-title":"Human Papillomavirus and the Long-term Risk of Cervical Neoplasia","volume":"156","author":"Y van der Graaf","year":"2002","journal-title":"American Journal of Epidemiology"},{"issue":"7","key":"pone.0320978.ref009","doi-asserted-by":"crossref","first-page":"1274","DOI":"10.1158\/1055-9965.EPI-06-0129","article-title":"Human Papillomavirus Infections with Multiple Types and Risk of Cervical Neoplasia","volume":"15","author":"H Trottier","year":"2006","journal-title":"Cancer Epidemiology, Biomarkers & Prevention"},{"issue":"9","key":"pone.0320978.ref010","doi-asserted-by":"crossref","first-page":"1144","DOI":"10.1016\/j.cmi.2020.03.033","article-title":"Commercially available molecular tests for human papillomaviruses: a global overview","volume":"26","author":"M Poljak","year":"2020","journal-title":"Clin Microbiol Infect"},{"issue":"3","key":"pone.0320978.ref011","doi-asserted-by":"crossref","first-page":"516","DOI":"10.1002\/ijc.24010","article-title":"Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older","volume":"124","author":"CJLM Meijer","year":"2009","journal-title":"Int J Cancer"},{"issue":"Suppl 1","key":"pone.0320978.ref012","doi-asserted-by":"crossref","first-page":"S14","DOI":"10.1016\/j.jcv.2015.09.014","article-title":"VALGENT: A protocol for clinical validation of human papillomavirus assays","volume":"76","author":"M Arbyn","year":"2016","journal-title":"J Clin Virol"},{"issue":"1","key":"pone.0320978.ref013","doi-asserted-by":"crossref","first-page":"353","DOI":"10.1186\/s12905-021-01493-0","article-title":"Significance of the viral load of high-risk HPV in the diagnosis and prediction of cervical lesions: a retrospective study","volume":"21","author":"Y Liu","year":"2021","journal-title":"BMC Womens Health"},{"issue":"3","key":"pone.0320978.ref014","doi-asserted-by":"crossref","first-page":"396","DOI":"10.1002\/ijc.11222","article-title":"Persistence and load of high-risk HPV are predictors for development of high-grade cervical lesions: A longitudinal French cohort study","volume":"106","author":"V Dalstein","year":"2003","journal-title":"International Journal of Cancer"},{"issue":"9328","key":"pone.0320978.ref015","doi-asserted-by":"crossref","first-page":"228","DOI":"10.1016\/S0140-6736(02)09463-1","article-title":"Viral load of human papillomavirus and risk of CIN3 or cervical cancer","volume":"360","author":"AT Lorincz","year":"2002","journal-title":"Lancet"},{"issue":"12","key":"pone.0320978.ref016","doi-asserted-by":"crossref","first-page":"2195","DOI":"10.1038\/sj.bjc.6602648","article-title":"Type distribution, viral load and integration status of high-risk human papillomaviruses in pre-stages of cervical cancer (CIN)","volume":"92","author":"S Andersson","year":"2005","journal-title":"Br J Cancer"},{"issue":"3","key":"pone.0320978.ref017","doi-asserted-by":"crossref","first-page":"549","DOI":"10.1016\/j.ygyno.2007.11.009","article-title":"The association of pre-conization high-risk HPV load and the persistence of HPV infection and persistence\/recurrence of cervical intraepithelial neoplasia after conization","volume":"108","author":"JY Park","year":"2008","journal-title":"Gynecol Oncol"},{"issue":"5","key":"pone.0320978.ref018","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1007\/s12032-020-01363-z","article-title":"HR-HPV viral load quality detection provide more accurate prediction for residual lesions after treatment: a prospective cohort study in patients with high-grade squamous lesions or worse","volume":"37","author":"L Chen","year":"2020","journal-title":"Med Oncol"},{"issue":"4","key":"pone.0320978.ref019","doi-asserted-by":"crossref","first-page":"e00081-23","DOI":"10.1128\/spectrum.00081-23","article-title":"Comparison between the Roche Cobas 4800 Human Papillomavirus (HPV), Abbott RealTime High-Risk HPV, Seegene Anyplex II HPV28, and Novel Seegene Allplex HPV28 Assays for High-Risk HPV Detection and Genotyping in Mocked Self-Samples","volume":"11","author":"M Bell","year":"2023","journal-title":"Microbiology Spectrum"},{"key":"pone.0320978.ref020","doi-asserted-by":"crossref","first-page":"105638","DOI":"10.1016\/j.jcv.2023.105638","article-title":"Allplex HPV HR Detection assay fulfils all clinical performance and reproducibility validation requirements for primary cervical cancer screening","volume":"170","author":"A O\u0161trbenk Valen\u010dak","year":"2024","journal-title":"Journal of Clinical Virology"},{"issue":"6","key":"pone.0320978.ref021","doi-asserted-by":"crossref","first-page":"1852","DOI":"10.1128\/JCM.37.6.1852-1857.1999","article-title":"Nonisotopic detection and typing of human papillomavirus DNA in genital samples by the line blot assay. The Canadian Women\u2019s HIV study group","volume":"37","author":"F Coutl\u00e9e","year":"1999","journal-title":"J Clin Microbiol"},{"issue":"2","key":"pone.0320978.ref022","doi-asserted-by":"crossref","first-page":"651","DOI":"10.1128\/JCM.38.2.651-655.2000","article-title":"Comparison of Human Papillomavirus Detection and Typing by Cycle Sequencing, Line Blotting, and Hybrid Capture","volume":"38","author":"SD Vernon","year":"2000","journal-title":"Journal of Clinical Microbiology"},{"issue":"6","key":"pone.0320978.ref023","doi-asserted-by":"crossref","first-page":"2824","DOI":"10.1002\/jmv.27605","article-title":"Human Papillomavirus genotype concordance between Anyplex II HPV28 and Linear array HPV genotyping test in anogenital samples","volume":"94","author":"F Coutl\u00e9e","year":"2022","journal-title":"Journal of medical virology"},{"issue":"6","key":"pone.0320978.ref024","doi-asserted-by":"crossref","first-page":"518","DOI":"10.1056\/NEJMoa021641","article-title":"Epidemiologic classification of human papillomavirus types associated with cervical cancer","volume":"348","author":"N Mu\u00f1oz","year":"2003","journal-title":"N Engl J Med"},{"issue":"6","key":"pone.0320978.ref025","doi-asserted-by":"crossref","first-page":"464","DOI":"10.1093\/jnci\/92.6.464","article-title":"Population-Based Study of Human Papillomavirus Infection and Cervical Neoplasia in Rural Costa Rica","volume":"92","author":"R Herrero","year":"2000","journal-title":"JNCI: Journal of the National Cancer Institute"},{"issue":"2","key":"pone.0320978.ref026","doi-asserted-by":"crossref","first-page":"176","DOI":"10.1016\/j.virusres.2006.12.017","article-title":"Prevalence and distribution of single and multiple HPV infections in cytologically abnormal cervical samples from Italian women","volume":"125","author":"F Gargiulo","year":"2007","journal-title":"Virus Res"},{"issue":"9490","key":"pone.0320978.ref027","doi-asserted-by":"crossref","first-page":"991","DOI":"10.1016\/S0140-6736(05)67069-9","article-title":"Worldwide distribution of human papillomavirus types in cytologically normal women in the International Agency for Research on Cancer HPV prevalence surveys: a pooled analysis","volume":"366","author":"GM Clifford","year":"2005","journal-title":"The Lancet"},{"issue":"7","key":"pone.0320978.ref028","doi-asserted-by":"crossref","first-page":"910","DOI":"10.1093\/infdis\/jiq139","article-title":"Human Papillomavirus Infection with Multiple Types: Pattern of Coinfection and Risk of Cervical Disease","volume":"203","author":"AK Chaturvedi","year":"2011","journal-title":"The Journal of Infectious Diseases"},{"issue":"7","key":"pone.0320978.ref029","doi-asserted-by":"crossref","first-page":"1158","DOI":"10.1086\/444391","article-title":"Cervical coinfection with human papillomavirus (HPV) types and possible implications for the prevention of cervical cancer by HPV vaccines","volume":"192","author":"F Mendez","year":"2005","journal-title":"J Infect Dis"},{"issue":"4","key":"pone.0320978.ref030","doi-asserted-by":"crossref","first-page":"989","DOI":"10.1007\/s00404-010-1747-z","article-title":"Human papillomavirus genotype distribution in cervical samples collected in routine clinical practice at the Nantes University Hospital, France","volume":"284","author":"E Vaucel","year":"2011","journal-title":"Arch Gynecol Obstet"},{"key":"pone.0320978.ref031","volume-title":"ICO\/IARC Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in France. Summary Report 10 March 2023. Accessed September 23, 2023. [Internet]. [cited 2023 Sep 23]","author":"L Bruni"},{"issue":"1","key":"pone.0320978.ref032","doi-asserted-by":"crossref","first-page":"e86835","DOI":"10.1371\/journal.pone.0086835","article-title":"Disagreement between human papillomavirus assays: an unexpected challenge for the choice of an assay in primary cervical screening","volume":"9","author":"M Rebolj","year":"2014","journal-title":"PLoS One"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0320978","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,1]],"date-time":"2025-04-01T21:28:29Z","timestamp":1743542909000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0320978"}},"subtitle":[],"editor":[{"given":"Ivan","family":"Sabol","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,4,1]]},"references-count":32,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2025,4,1]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0320978","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4,1]]}}}