Arch Gynecol Obstet. 2026 Jun 25;313(1):210. doi: 10.1007/s00404-026-08457-5.
ABSTRACT
OBJECTIVE: Cervical cancer and its precursor lesions are treatable if detected early; however, screening participation for high-risk human papillomavirus infections (hr-HPV) remains low. In 2021, Germany recorded 4,544 new cervical cancer cases and 2,071 related deaths. The HaSCo study evaluates the feasibility of HPV self-testing to improve screening participation. This sub-study evaluates performance and acceptability of three self-testing tools.
METHODS: This prospective, randomized sub-study examined Evalyn-Brush, FLOQSwabs, and first-void urine Colli-Pee among women aged 30-65 in Hannover, Germany. Addresses from the residents´ registration office were randomized into seven age groups and an 80/20 city-region distribution. A total of 19,995 women were assigned to opt-in (request a self-test) or opt-out (receive a test directly). Participation was requested from women without regular screening in the past two years.
RESULTS: 1,860 samples were returned (9.3%). Colli-Pee (10.4%) and FLOQSwabs (10.1%) had similar return rates, while Evalyn showed significantly lower rates (7.4%). Screening frequency didn´t significantly affect return rates (p = 0.1825), although FLOQSwabs showed higher return rates among underscreened women. Invalid sample rates were low, highest for FLOQSwabs (1.67%). A total of 145 samples tested positive for hr-HPV (7.9%). Evalyn collected highest DNA content (p < 0.0001). Colli-Pee was most preferred, and 66.7% of participants favored self-testing.
CONCLUSION: HPV self-tests were highly accepted and effective for collecting sufficient DNA material. Direct provision of user-friendly self-tests may support screening participation, particularly among underscreened women. All three devices performed strongly and appear suitable for integration into cervical cancer screening programs.
PMID:42347973 | DOI:10.1007/s00404-026-08457-5
