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Objective <p>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.</p> Methods <p>This prospective, randomized sub-study examined Evalyn-Brush, FLOQSwabs, and first-void urine&#xa0;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.</p> Results <p>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 &lt; 0.0001). Colli-Pee was most preferred, and 66.7% of participants favored self-testing.</p> Conclusion <p>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.</p>

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Comparison of three different hpv self-sampling tools – a subanalysis of the prospective, randomized hannover self-collection study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月25日

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  • Stephanie Hempel,
  • Sophia Groß,
  • Lena Steinkasserer,
  • Leonie Theis,
  • Yvonne Ziert,
  • Armin Koch,
  • Peter Hillemanns,
  • Matthias Jentschke

摘要

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.