{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T14:31:24Z","timestamp":1787063484311,"version":"build-2736575974"},"reference-count":28,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,6,7]],"date-time":"2024-06-07T00:00:00Z","timestamp":1717718400000},"content-version":"vor","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    To meet the screening goal of WHO's 90\u201070\u201090 strategy aimed at eliminating cervical cancer (CC) by 2030, clinical validation of human papillomavirus (HPV) assays is essential to provide accurate and valid results through fulfilling three criteria of the international validation guidelines (IVGs). Previously, the clinical accuracy of the AmpFire\u00ae HPV Screening 16\/18\/HR assay (AmpFire assay) was reported but reproducibility data are lacking. Here, we aim to evaluate the intra\u2010 and inter\u2010laboratory reproducibility of the AmpFire assay. The reproducibility of the isothermal AmpFire assay was assessed using 556 cervical cell samples collected from women attending CC screening and biobanked in a Belgian HPV national reference center. This assay detects HPV16, HPV18, and 12 other high\u2010risk HPV (hrHPV) types (31\/33\/35\/39\/45\/51\/52\/56\/58\/59\/66\/68) in aggregate. Lower 95% confidence interval bound around the assay's reproducibility should exceed 87%, with\n                    <jats:italic>\u03ba<\/jats:italic>\n                    \u2009\u2265\u20090.50. Additionally, a literature review of the assay's clinical performance was performed. The AmpFire assay showed an excellent intralaboratory (96.4%, 95% CI:94.5\u201397.8%,\n                    <jats:italic>\u03ba<\/jats:italic>\n                    \u2009=\u20090.920) and interlaboratory (95.3%, 95% CI:93.2\u201396.9%,\n                    <jats:italic>\u03ba<\/jats:italic>\n                    \u2009=\u20090.897) reproducibility. One study demonstrated noninferior sensitivity of a prototype AmpFire assay targeting 15 hrHPV types (including HPV53) to detect CIN2+. However, clinical specificity became similar to the comparator after removing HPV53 from analyses. The low\u2010cost and easy\u2010to\u2010use AmpFire assay presents excellent reproducibility and\u2014after removing HPV53 from the targeted types\u2014fulfills also clinical accuracy requirements. Inclusion of HPV53, which is not recognized as carcinogenic, comprises clinical specificity of screening assays.\n                  <\/jats:p>","DOI":"10.1002\/jmv.29688","type":"journal-article","created":{"date-parts":[[2024,6,7]],"date-time":"2024-06-07T06:55:00Z","timestamp":1717743300000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Intra\u2010 and interlaboratory reproducibility evaluation toward international validation status of the AmpFire assay"],"prefix":"10.1002","volume":"96","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"}]},{"given":"Alice","family":"Baraquin","sequence":"additional","affiliation":[{"name":"CHU Besan\u00e7on, Centre National de R\u00e9f\u00e9rence Papillomavirus Besan\u00e7on France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuliya","family":"Tkachenka","sequence":"additional","affiliation":[{"name":"Department of Clinical Trials Sonic Healthcare Benelux\u2014AML Antwerp Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Killian","family":"Jacquot","sequence":"additional","affiliation":[{"name":"CHU Besan\u00e7on, Centre National de R\u00e9f\u00e9rence Papillomavirus Besan\u00e7on France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8430-214X","authenticated-orcid":false,"given":"Jean\u2010Luc","family":"Pr\u00e9tet","sequence":"additional","affiliation":[{"name":"CHU Besan\u00e7on, Centre National de R\u00e9f\u00e9rence Papillomavirus Besan\u00e7on France"},{"name":"Carcinogen\u00e8se associ\u00e9e aux HPV Universit\u00e9 de Franche\u2010Comt\u00e9 Besan\u00e7on France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davy Vanden","family":"Broeck","sequence":"additional","affiliation":[{"name":"Department of Primary Healthcare, Faculty of Medicine and Health Sciences University Ghent Ghent Belgium"},{"name":"Department of Molecular Diagnostics Sonic Healthcare Benelux\u2014AML Antwerp Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7807-5908","authenticated-orcid":false,"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 University Ghent Ghent Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,6,7]]},"reference":[{"key":"e_1_2_12_2_1","volume-title":"Global Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem","author":"WHO team\u2014Cervical Cancer Elimination Initiative","year":"2020"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(19)30482-6"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(09)70096-8"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(19)30488-7"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21660"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(22)00501-0"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsr2030640"},{"key":"e_1_2_12_9_1","volume-title":"Human Papillomavirus and Related Diseases Report","author":"ICO\/IARC 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Comparison of the AmpFire multiplex HPV assay to the xpert HPV assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: A pragmatic performance evaluation.Res Sq. 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