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

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 genotype...

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Detalles Bibliográficos
Autores: Bellosillo Paricio, Beatriz, Ibañez, Raquel, Roura, Esther, Monfil, Laura, Asensio Puig, Laura, Álvarez, Isabel, Muset, Mercè, Florencia, Yolanda, Paytubi, Sonia, Andrés Pablo, Álvaro de, Calvo, Susana, Serrano-Munné, Laia, Pavón, Miquel Ángel, Lloveras Rubio, Belen
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:10230/69902
Acceso en línea:http://hdl.handle.net/10230/69902
http://dx.doi.org/10.3390/cancers16071322
Access Level:acceso abierto
Palabra clave:HPV
Vitro HPV
Cervical cancer
Cervical screening
Genotyping
Human papillomavirus
Validation
Descripción
Sumario: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.

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