Journal Article

Correction: 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

Puzzi, Luca, Zanolla, Shivani, Di Napoli, Michela, Mauro, Elisabetta, Sola, Riccardo, Dudine, Sandra, Del Fabro, Anna, Valenti, Giulio, Foschi, Nicola, Sopracordevole, Francesco, Angeletti, Silvia, Gerin, Daniela, Giudici, Fabiola, Montrone, Michele, Morini, Stefano, Mocenigo, Marco, Pachetti, Maria, Ippodrino, Rudy, Cammisuli, Tamara, Avian, Alice, Riva, Elisabetta, Vogrig, Enea, Castriciano, Santina, Canzonieri, Vincenzo, Petti, Matteo, Marini, Bruna, Banks, Lawrence, Modena, Chiara, Isidoro, Erica, Tomaic, Vjekoslav, Zanconati, Fabrizio, Ciccozzi, Massimo, Clemente, Nicolò, Perin, Tiziana, Centonze, Sandro, Polenghi, Martina

2023

Overview

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 specificity 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. [...]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 (0.97 relative sensitivity and 0.97 relative specificity). [...]through HPV Selfy genotyping, we were able to describe HPV types prevalence in the study population. [...]we needed to assess whether HPV testing on vaginal self-samples was as accurate as HPV testing on a cervical sample taken by a clinician. HPV Selfy testing in self-collected samples was found similarly sensitive (93/96; relative sensitivity 0.97; 95% CI 0.90–1.04) and specific (722/745; relative specificity 0.97; 95% CI 0.95–0.99) to detect CIN2+ in the total study population (Table 4), in comparison with HPV Selfy performed on paired ThinPrep. [...]HPV Selfy assay fulfills VALHUDES requirements for use of HR-HPV DNA tests on self-collected samples according to non-inferiority analysis (relative sensitivity > 0.90 with T = 1.70, p = 0.044; relative specificity > 0.95 with T = 1.87, p =0.031).

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Biomedical and Life Sciences / Biomedicine / Correction / Medicine/Public Health