Clinical validation of the Vitro HPV screening assay for its use in primary cervical cancer screening

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• dc.contributor.author Bellosillo Paricio, Beatriz
• dc.contributor.author Ibañez, Raquel
• dc.contributor.author Roura, Esther
• dc.contributor.author Monfil, Laura
• dc.contributor.author Asensio Puig, Laura
• dc.contributor.author Álvarez, Isabel
• dc.contributor.author Muset, Mercè
• dc.contributor.author Florencia, Yolanda
• dc.contributor.author Paytubi, Sonia
• dc.contributor.author Andrés Pablo, Álvaro de
• dc.contributor.author Calvo, Susana
• dc.contributor.author Serrano-Munné, Laia
• dc.contributor.author Pavón, Miquel Ángel
• dc.contributor.author Lloveras Rubio, Belen
• dc.date.accessioned 2025-03-11T07:12:49Z
• dc.date.available 2025-03-11T07:12:49Z
• dc.date.issued 2024
• dc.description.abstract Many scientific societies have issued guidelines to introduce population-based cervical cancer screening with HPV testing. The Vitro HPV Screening assay is a fully automatic multiplex real-time PCR test targeting the L1 GP5+/GP6+ region of HPV genome. The assay detects 14 high risk (HR) HPV genotypes, identifying individual HPV16 and HPV18 genotypes, and the HPV-positive samples for the other 12 HR HPV types are subsequently genotyped with the HPV Direct Flow Chip test. Following international guidelines, the aim of this study was to validate the clinical accuracy of the Vitro HPV Screening test on ThinPrep-collected samples for its use as primary cervical cancer screening, using as comparator the validated cobas® 4800 HPV test. The non-inferiority analysis showed that the clinical sensitivity and specificity of the Vitro HPV Screening assay for a diagnosis of cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) were not inferior to those of cobas® 4800 HPV (p = 0.0049 and p < 0.001 respectively). The assay has demonstrated a high intra- and inter-laboratory reproducibility, also among the individual genotypes. The Vitro HPV Screening assay is valid for cervical cancer screening and it provides genotyping information on HPV-positive samples without further sample processing in a fully automated workflow.
• dc.format.mimetype application/pdf
• dc.identifier.citation Bellosillo B, Ibáñez R, Roura E, Monfil L, Asensio-Puig L, Álvarez I, et al. Clinical validation of the Vitro HPV screening assay for its use in primary cervical cancer screening. Cancers (Basel). 2024 Mar 28;16(7):1322. DOI: 10.3390/cancers16071322
• dc.identifier.doi http://dx.doi.org/10.3390/cancers16071322
• dc.identifier.issn 2072-6694
• dc.identifier.uri http://hdl.handle.net/10230/69902
• dc.language.iso eng
• dc.publisher MDPI
• dc.relation.ispartof Cancers (Basel). 2024 Mar 28;16(7):1322
• dc.rights © 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword HPV
• dc.subject.keyword Vitro HPV
• dc.subject.keyword Cervical cancer
• dc.subject.keyword Cervical screening
• dc.subject.keyword Genotyping
• dc.subject.keyword Human papillomavirus
• dc.subject.keyword Validation
• dc.title Clinical validation of the Vitro HPV screening assay for its use in primary cervical cancer screening
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion