Journal Article

The Use of Self-Sampling Devices via a Smartphone Application to Encourage Participation in Cervical Cancer Screening: A Pilot Study

Avian, Alice, Fais, Giuseppina, De Cicco Nardone, Carlo, Riva, Elisabetta, Terranova, Corrado, Castriciano, Santina, Cundari, Gianna Barbara, Angioli, Roberto, Plotti, Francesco, Angeletti, Silvia, Ciccozzi, Massimo, Ficarola, Fernando, Luvero, Daniela, Montera, Roberto

2025

Overview

Background: Cervical cancer ranks among the most prevalent tumors in low-income countries, with the Pap test as one of the primary screening tools. The Pap smear detects abnormal cells, the CLART test identifies specific HPV genotypes, and HPV self-sampling allows for self-collected HPV testing. This study aimed to evaluate the feasibility of the first smartphone-based health device for home-collection HPV testing. Methods: Enrolled patients during the gynecological examination underwent three different samplings: Pap smear, HPV DNA genotyping test CLART, and vaginal HPV-Selfy swab. Each patient received a kit including an activation code, vaginal swab, and instructions. After performing the self-sample, patients returned the kit to our laboratory. Both the samples collected by the gynecologist and those collected by the patients themselves were analyzed. Results: A total of 277 patients were enrolled, with 226 self-collected swabs received for analysis. The assay yielded valid results for both self-collected and clinician-collected swabs in 190 patients. When comparing these results with paired clinician-taken vaginal swabs, we observed an agreement of 95.2% (Cohen’s Kappa: 0.845). We report an agreement of 93.7% (Cohen’s Kappa: 0.798). Conclusions: The study demonstrated the feasibility of HPV-Selfy as a complementary tool in cervical cancer screening, especially where adherence to traditional surveillance is low.

• Publisher: MDPI AG,MDPI
• Subject: Medical screening / Smartphones / Telemedicine / Womens health