Clinical validation of full HR-HPV genotyping HPV Selfy assay according to the international guidelines for HPV test requirements for cervical cancer screening on clinician-collected and self-collected samples

Avian, Alice; Clemente, Nicolò; Mauro, Elisabetta; Isidoro, Erica; Di Napoli, Michela; Dudine, Sandra; Del Fabro, Anna; Morini, Stefano; Perin, Tiziana; Giudici, Fabiola; Cammisuli, Tamara; Foschi, Nicola; Mocenigo, Marco; Montrone, Michele; Modena, Chiara; Polenghi, Martina; Puzzi, Luca; Tomaić, Vjekoslav; Valenti, Giulio; Sola, Riccardo; Zanolla, Shivani; Vogrig, Enea; Riva, Elisabetta; Angeletti, Silvia; Ciccozzi, Massimo; Castriciano, Santina; Pachetti, Maria; Petti, Matteo; Centonze, Sandro; Gerin, Daniela; Banks, Lawrence; Marini, Bruna; Canzonieri, Vincenzo; Sopracordevole, Francesco; Zanconati, Fabrizio; Ippodrino, Rudy (2022) Clinical validation of full HR-HPV genotyping HPV Selfy assay according to the international guidelines for HPV test requirements for cervical cancer screening on clinician-collected and self-collected samples. Journal of Translational Medicine, 20 (1). ISSN 1479-5876

PDF - Published Version - article Available under License Creative Commons Attribution. Download (1MB)

Abstract

Background: According to international guidelines, Human Papillomavirus (HPV) DNA tests represent a valid alternative to Pap Test for primary cervical cancer screening, provided that they guarantee balanced clinical sensitivity and specifcity for cervical intraepithelial neoplasia grade 2 or more (CIN2+) lesions. The study aimed to assess whether HPV Selfy (Ulisse BioMed – Trieste, Italy), a full-genotyping HPV DNA test that detects and diferentiates 14 high-risk HPV (HR-HPV) types, meets the criteria for primary cervical cancer screening described in the international guidelines, on clinician-collected as well as on self-collected samples. Methods: For each participant woman, consecutively referring to Azienda Sanitaria Universitaria Giuliano Isontina (Trieste, Italy) and CRO—National Cancer Institute (Aviano, Italy) for the cervical cancer screening program, the following samples were tested: (a) a clinician-collected cervical specimen, analyzed with the reference test (Hybrid Capture®2 test, HC2) and HPV Selfy; and (b) a self-collected vaginal sample, analyzed with HPV Selfy. Enrolled women were also asked to fulfll a questionnaire about self-sampling acceptability. As required by guidelines, a non-inferiority test was conducted to compare the clinical performance of the test under evaluation with its reference test. Results: HPV Selfy clinical sensitivity and specifcity resulted non-inferior to those of HC2. By analysis of a total of 889 cervical liquid-based cytology samples from a screening population, of which 98 were from women with CIN2+, HPV Selfy showed relative sensitivity and specifcity for CIN2+of 0.98 and 1.00 respectively (non-inferiority score test: P=0.01747 and P=0.00414, respectively); the test reached adequate intra- and inter-laboratory reproducibility. Moreover, we demonstrated that the performance of HPV Selfy on self-collected vaginal samples was non-inferior to the performance obtained on clinician-collected cervical specimen (0.92 relative sensitivity and 0.97 relative specifcity). Finally, through HPV Selfy genotyping, we were able to describe HPV types prevalence in the study population. Conclusions: HPV Selfy fulflls all the requirements of the international Meijer’s guidelines and has been clinically validated for primary cervical cancer screening purposes. Moreover, HPV Selfy has also been validated for self-sampling according to VALHUDES guidelines. Therefore, at date, HPV Selfy is the only full-genotyping test validated both for screening purposes and for self-sampling.

Item Type:	Article
Uncontrolled Keywords:	Human Papillomavirus; HPV; Cervical cancer; HPV test; Clinical performance; Cervical cancer screening; Self-sampling; HPV genotyping; Meijer’s guidelines; VALHUDES
Subjects:	BIOMEDICINE AND HEALTHCARE > Clinical Medical Sciences
Divisions:	Division of Molecular Medicine
Depositing User:	Diana Mikoč Radešić
Date Deposited:	30 Jan 2024 12:42
URI:	http://fulir.irb.hr/id/eprint/8412
DOI:	10.1186/s12967-022-03383-x

Actions (login required)

View Item