Evaluation of the feasibility of human papillomavirus sponge‐type self‐sampling device at Japanese colposcopy clinics

AIM: Self‐sampling human papillomavirus (HPV) testing has been introduced for cervical cancer screening worldwide. In Japan, there are two types (brush and sponge) of HPV self‐sampling devices. However, the recommended type for cervical cancer screening remains unclear. This study aimed to evaluate the feasibility of the HPV self‐sampling device–sponge type (HSD‐ST). Additionally, we aimed to examine the positive rate (sensitivity) for cervical intraepithelial neoplasia (CIN) 2 or worse using the HSD‐ST. Finally, we aimed to perform a questionnaire survey regarding the usability of the HSD‐ST. METHODS: We included 165 women who underwent HPV testing at one of three gynecologic clinics. First, the women used the HSD‐ST and completed a questionnaire regarding its usability. Subsequently, they underwent physician‐sampling HPV testing and cytology. We examined the agreement rate of HPV positivity between self‐ and physician‐sampling HPV testing. RESULTS: The HPV‐positive rates of self‐ and physician‐collected samples were 59.4% and 62.4%, respectively, with an overall concordance rate of 88.5% and a calculated kappa coefficient of 0.76, indicating high concordance. Moreover, the positive (sensitivity) rates for CIN2 or worse were 81.4% and 89.8% in the self‐ and physician‐collected samples, respectively. CONCLUSIONS: Our findings demonstrated the feasibility and usability of the HSD‐ST.