{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T14:56:58Z","timestamp":1787065018306,"version":"build-2736575974"},"reference-count":26,"publisher":"American Society for Microbiology","issue":"8","license":[{"start":{"date-parts":[[2024,8,6]],"date-time":"2024-08-06T00:00:00Z","timestamp":1722902400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,8,6]],"date-time":"2024-08-06T00:00:00Z","timestamp":1722902400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/501100000780","name":"European Commission","doi-asserted-by":"publisher","award":["847845"],"award-info":[{"award-number":["847845"]}],"id":[{"id":"10.13039\/501100000780","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Microbiol Spectr"],"published-print":{"date-parts":[[2024,8,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Clinically validated human papillomavirus (HPV) assays are crucial in cervical cancer screening. In this study, we evaluated the Allplex HPV HR Detection assay (Seegene, SouthKorea) for its clinical accuracy and reproducibility according to the international criteria, using the RealTime High Risk HPV m2000 assay (Abbott, USA) as standard comparator. The Allplex HPV HR assay exhibits significant non-inferior sensitivity to detect cervical intraepithelial neoplasia grade (CIN) 2 or worse (CIN2+) with a ratio of 1.00 (95% CI: 0.97\u20131.03,\n                      <jats:italic>P<\/jats:italic>\n                      = 0.006), insignificant non-inferior sensitivity to detect CIN3+ with a ratio of 1.00 (95% CI: 0.88\u20131.13,\n                      <jats:italic>P<\/jats:italic>\n                      = 0.098), and non-inferior specificity to exclude CIN2+ with a ratio of 0.99 (95% CI: 0.99\u20131.00,\n                      <jats:italic>P<\/jats:italic>\n                      &lt; 0.001) compared to the standard comparator. In addition, the assay shows an excellent reproducibility within the same laboratory [96.5% (95% CI: 94.6\u201397.9) with a kappa value of 0.91 (95% CI: 0.87\u20130.95)] and between laboratories [96.7% (95% CI: 94.8\u201398.0) with a kappa value of 0.91 (95% CI: 0.87\u20130.95)] for overall high-risk HPV positivity as well as for each individual HPV type. Pooling our study data with those of another independent study supports the consistency of our findings. We conclude that both the clinical accuracy to detect cervical precancer and the reproducibility of Allplex HPV HR Detection assay fulfill the international validation criteria of use in cervical cancer screening.\n                    <\/jats:p>\n                    <jats:sec>\n                      <jats:title>IMPORTANCE<\/jats:title>\n                      <jats:p>The clinical validation of human papillomavirus (HPV) assays in accordance with well-established international guidelines is crucial to ensure that only validated assays are used in the context of screening (Meijer et al., Int J Cancer, 2009). The guidelines, developed by an international consortium, require that a novel HPV assay has non-inferior accuracy against a standard comparator test for the detection of cervical intraepithelial neoplasia grade (CIN) 2 or worse (CIN2+). Additionally, a new HPV assay should meet specific criteria for both intra- and inter-laboratory reproducibility to ensure the assay consistently exhibits technical precision and robust performance. Pooling our study data with those of another independent study supports the consistency of our findings. In conclusion, both the clinical accuracy to detect cervical precancer and the reproducibility of Allplex HPV HR Detection assay fulfill the international validation criteria of use in cervical cancer screening.<\/jats:p>\n                    <\/jats:sec>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.00332-24","type":"journal-article","created":{"date-parts":[[2024,6,25]],"date-time":"2024-06-25T09:01:32Z","timestamp":1719306092000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":4,"title":["Evaluation of the Allplex HPV assay\u2019s adherence to international guidelines for cervical cancer screening in clinician-collected samples"],"prefix":"10.1128","volume":"12","author":[{"given":"Pui Yan Jenny","family":"Chung","sequence":"first","affiliation":[{"name":"Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharonjit K.","family":"Dhillon","sequence":"additional","affiliation":[{"name":"Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-5359-6672","authenticated-orcid":true,"given":"Selina","family":"Cortoos","sequence":"additional","affiliation":[{"name":"Department of Molecular Diagnostics, Sonic Healthcare Benelux \u2013 AML, Antwerp, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannelore","family":"Hamerlinck","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology, Ghent University Hospital, Ghent, Belgium"},{"name":"Department of Diagnostics Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Pereira","sequence":"additional","affiliation":[{"name":"Department of Molecular Diagnostics, Sonic Healthcare Benelux \u2013 AML, Antwerp, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizaveta","family":"Padalko","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology, Ghent University Hospital, Ghent, Belgium"},{"name":"Department of Diagnostics Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davy","family":"Vanden Broeck","sequence":"additional","affiliation":[{"name":"Department of Molecular Diagnostics, Sonic Healthcare Benelux \u2013 AML, Antwerp, Belgium"},{"name":"International Centre for Reproductive Health, Ghent University, Ghent, Belgium"},{"name":"National Reference Centre for HPV, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7807-5908","authenticated-orcid":true,"given":"Marc","family":"Arbyn","sequence":"additional","affiliation":[{"name":"Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium"},{"name":"Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/s1470-2045(09)70096-8"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21660"},{"key":"e_1_3_5_4_2","volume-title":"IARC handbooks of cancer prevention","author":"International Agency for Research on Cancer","year":"2022","unstructured":"International Agency for Research on Cancer. 2022 Cervical cancer screening. In IARC handbooks of cancer prevention. Vol. 18. https:\/\/publications.iarc.fr\/604."},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-2667(20)30122-5"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD008587.pub2"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2012.06.095"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(09)70360-2"},{"key":"e_1_3_5_9_2","unstructured":"World Health Organization. 2021. WHO guideline for screening and treatment of Cervical pre-cancer lesions for Cervical cancer prevention. World Health Organization Geneva. Available from: http:\/\/www.ncbi.nlm.nih.gov\/books\/NBK572317\/. Retrieved 27 Oct 2023."},{"key":"e_1_3_5_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2020.03.033"},{"key":"e_1_3_5_11_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.24010"},{"key":"e_1_3_5_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2023.105638"},{"key":"e_1_3_5_13_2","doi-asserted-by":"publisher","DOI":"10.1515\/cclm.2011.835"},{"key":"e_1_3_5_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2021.04.031"},{"key":"e_1_3_5_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02311-10"},{"key":"e_1_3_5_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00012-11"},{"key":"e_1_3_5_17_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00633-13"},{"key":"e_1_3_5_18_2","doi-asserted-by":"publisher","DOI":"10.1177\/1536867X0800800102"},{"key":"e_1_3_5_19_2","doi-asserted-by":"publisher","DOI":"10.3390\/v14050893"},{"key":"e_1_3_5_20_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.05552-11"},{"key":"e_1_3_5_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2011.03.010"},{"key":"e_1_3_5_22_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00286-21"},{"key":"e_1_3_5_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2014.01.015"},{"key":"e_1_3_5_24_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01743-09"},{"key":"e_1_3_5_25_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12885-020-06888-0"},{"key":"e_1_3_5_26_2","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.29093"},{"key":"e_1_3_5_27_2","doi-asserted-by":"publisher","DOI":"10.1097\/LGT.0000000000000573"}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.00332-24","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.00332-24","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,6]],"date-time":"2024-08-06T09:14:57Z","timestamp":1722935697000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.00332-24"}},"subtitle":[],"editor":[{"given":"Yi-Chin","family":"Fan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2024,8,6]]},"references-count":26,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2024,8,6]]}},"alternative-id":["10.1128\/spectrum.00332-24"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.00332-24","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8,6]]},"assertion":[{"value":"2024-02-09","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-02","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-25","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00332-24"}}