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

TL;DR

This pilot study tested a smartphone-based device for self-collected HPV testing at home, showing high agreement with traditional methods and potential to improve cervical cancer screening.

Contribution

The study introduces a smartphone-based HPV self-sampling device as a feasible and user-friendly tool for cervical cancer screening.

Findings

226 out of 277 enrolled patients successfully returned self-collected swabs for analysis.

Self-collected and clinician-collected samples showed 95.2% agreement in results.

The device demonstrated strong feasibility and potential for use in low adherence populations.

Abstract

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.

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