Obstetrics & Gynecology · Medical Literature
Comparison of three different hpv self-sampling tools - a subanalysis of the prospective, randomized hannover self-collection study.
Abstract
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. 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. 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. 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.
Clinical relevance
Among under-screened women aged 30–65 in Germany, which of three HPV self-sampling tools—Evalyn-Brush (vaginal brush), FLOQSwabs (vaginal flocked swab), or Colli-Pee (first-void urine collector)—achieves the highest sample return rate, lowest invalid rate, greatest DNA yield, and best user acceptability when offered through opt-in or opt-out delivery models? __SNAPSHOT__ {"studyDesign":"Prospective, randomized sub-study within the Hannover Self-Collection (HaSCo) population-based feasibility study","setting":"City of Hannover and surrounding region, Germany; community-based (addresses sourced from the residents' registration office); distributed 80% urban / 20% regional","sampleSize":"n = 19,995 women contacted; n = 1,860 samples returned (overall return rate 9.3%)","population":"Women aged 30–65 years without regular cervical cancer screening participation in the prior two years; randomized across seven age strata","intervention":"One of three CE-certified HPV self-sampling devices: Evalyn-Brush (vaginal brush, dry), FLOQSwabs (vaginal flocked swab, dry), or Colli-Pee (first-void urine collector); distributed via opt-in (women request kit) or opt-out (kit sent directly) models","comparator":"Head-to-head three-arm comparison of the three self-sampling devices; opt-in vs. opt-out delivery modality also compared","primaryOutcome":"Sample return rate (proportion of contacted women who returned a completed self-test); secondary outcomes included invalid sample rate, hr-HPV positivity rate, DNA yield, and user acceptability/preference","followUp":"Not reported (cross-sectional return of a single self-test; no longitudinal follow-up period specified in the abstract)","fundingSource":"Not reported in the abstract"}
Key findings
Of 19,995 women contacted, 1,860 returned a sample, yielding an overall return rate of 9.3%. By device, Colli-Pee achieved the highest return rate (10.4%), followed closely by FLOQSwabs (10.1%); Evalyn-Brush had a significantly lower return rate (7.4%). Prior screening frequency did not significantly affect return rates overall (p = 0.1825); however, FLOQSwabs demonstrated higher return rates specifically among underscreened women (magnitude not reported). Invalid sample rates were low across all three devices, with FLOQSwabs recording the highest invalid rate (1.67%; rates for Evalyn-Brush and Colli-Pee not separately reported in the abstract). Across all returned samples, 145 tested positive for hr-HPV, corresponding to an overall hr-HPV positivity rate of 7.9% (145/1,860; calculated). Evalyn-Brush yielded the highest DNA content (p < 0.0001 vs. both comparators). Regarding acceptability, Colli-Pee was the most preferred device among respondents, and 66.7% of participants favored self-testing overall. Absolute differences in return rates between Colli-Pee and FLOQSwabs: 0.3 percentage points (calculated); between FLOQSwabs and Evalyn-Brush: 2.7 percentage points (calculated). Confidence intervals and NNT/NNH for pairwise return rate comparisons were not reported. No serious adverse events were reported.
Practice implications
This sub-study establishes that population-level HPV self-sampling directed at under-screened German women is feasible and broadly acceptable, with two-thirds of participants favoring self-testing. All three devices yielded low invalid sample rates and an hr-HPV positivity rate consistent with a previously under-screened population. The Evalyn-Brush's significantly lower return rate (7.4% vs. ~10% for the other two devices) is a notable programmatic finding that may inform device selection in outreach programs, although the absolute between-device difference is modest. The observation that FLOQSwabs showed higher engagement among underscreened women is potentially relevant for targeting hard-to-reach subgroups, but no p-value or CI for this subgroup finding is reported, limiting confidence. Importantly, this study assessed feasibility and participation outcomes—not diagnostic accuracy; it does not establish whether any device is superior for detecting CIN 2+ or cervical cancer in this population. The overall return rate of 9.3% is low in absolute terms, underscoring that self-sampling alone is insufficient to achieve high population coverage and must be coupled with reminder systems, outreach strategies, or opt-out delivery. The study was restricted to women already known to be under-screened in one German city; generalizability to other health systems, age groups outside 30–65, immunocompromised women, or pregnant women is not established. Only the abstract was available for review; full methodology, subgroup analyses, device-specific hr-HPV positivity rates, and acceptability survey instruments are not assessable. __LIMITATIONS__ Overall return rate of 9.3% represents a highly selected participation bias: the 90.7% of non-responders are entirely uncharacterized, and the findings reflect only those willing to return a kit.,Sub-study design nested within the larger HaSCo study; randomization details (allocation concealment, whether device assignment was truly blinded at the distribution level) are not described in the abstract.,No diagnostic accuracy data (sensitivity, specificity, PPV, NPV for CIN 2+) are reported; the study cannot inform device selection on clinical performance grounds alone.,Device-specific hr-HPV positivity rates and invalid rates are incompletely reported (only aggregate HPV positivity and the FLOQSwabs invalid rate are stated), preventing cross-device diagnostic comparison.,The p-value for the Evalyn-Brush vs. comparator return rate difference and confidence intervals for all pairwise comparisons are not reported in the abstract, limiting precise statistical inference.,The subgroup finding favoring FLOQSwabs among underscreened women is reported without a p-value or CI, raising concern for post-hoc or exploratory analysis without pre-specified multiplicity adjustment.,Single-city, Germany-specific study with an 80/20 urban/regional split; generalizability to rural settings, other European healthcare systems, or low-resource settings is uncertain.,Funding source and potential conflicts of interest are not disclosed in the abstract, and device manufacturers may have interests in comparative outcomes.,Follow-up after a positive hr-HPV result (colposcopy referral rates, compliance) is not reported, a critical gap for assessing clinical effectiveness of self-sampling programs.,Only the abstract is publicly available; full peer-reviewed data including pre-registration, power calculations, and complete subgroup analyses cannot be verified. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ In this German population-based randomized feasibility study, HPV self-sampling was acceptable to two-thirds of participants and all three devices performed adequately, but the Evalyn-Brush had a significantly lower return rate (~7.4%) compared to FLOQSwabs and Colli-Pee (~10% each). The overall participation rate of 9.3% highlights that self-sampling alone is not sufficient to drive high-coverage screening. Clinicians and public health planners should interpret these results as feasibility data supporting device selection and delivery model design, not as evidence of clinical superiority of any device for HPV or cervical precancer detection.