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Reproductive Tract Infections Research / Cervical Cancer and HPV Research / Head and Neck Cancer Studies · Journal article
Diagnostics · August 28, 2026
Early or partial results. Treat as a signal, not a conclusion.
This pilot study reports high technical feasibility (97.7% valid HR-HPV results, 97.4% valid STI results) of a veil-based self-sampling device combined with digital logistics in a Romanian community screening programme of 960 women. The study documents epidemiological prevalence and associations between bacterial STIs and HR-HPV detection but does not compare clinical outcomes or screening performance against standard-of-care methods.
Uncontrolled pilot feasibility study. 960 adult women in Romania, mean age 41.3 years, enrolled in a community-based screening programme.. Intervention: Self-collected cervicovaginal sampling using Vaginal Veil Collector V-Veil UP2™ device, with molecular HPV and STI testing and digital platform logistics.. n = 960. Romania (community-based); samples transported to accredited laboratory in France for testing..
Technical success: 97.7% of samples yielded valid HR-HPV results and 97.4% for STIs Overall prevalence: 17.2% HR-HPV positive, 26.7% STI positive Age 18–29 group: highest risk at 22.2% for HR-HPV and 36.8% for STIs
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The high technical success and ambient-temperature stability of the veil-based device suggest potential to expand cervical cancer and STI screening reach in resource-limited or geographically dispersed settings. However, this pilot does not yet demonstrate whether self-sampling improves screening uptake, clinical outcomes, or cost-effectiveness compared to standard methods; such comparison and validation are needed before clinical adoption.
Single-centre pilot feasibility study with uncontrolled design and surrogate endpoints (molecular detection); demonstrates technical capability and epidemiological associations but lacks comparative evidence or clinical outcome data needed to guide practice.
As stated by the source record.
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The high technical success and ambient-temperature stability of the veil-based device suggest potential to expand cervical cancer and STI screening reach in resource-limited or geographically dispersed settings. However, this pilot does not yet demonstrate whether self-sampling improves screening uptake, clinical outcomes, or cost-effectiveness compared to standard methods; such comparison and validation are needed before clinical adoption.
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Background/Objectives: High-risk human papillomavirus (HR-HPV) causes cervical cancer, but other sexually transmitted infections (STIs) act as possible cofactors. We herein evaluated the feasibility, logistics, and epidemiology of a community-based screening program in Romania using an innovative veil-based self-sampling device and a digital platform. Methods: Adult women self-collected genital secretions using the Vaginal Veil Collector V-Veil UP2™ device (V-Veil-Up Production SRL, Pitesti, Romania). A digital platform managed registration and results. Dry impregnated veils were transported at ambient temperature via standard courier to an accredited French laboratory for molecular testing using in parallel the Allplex™ HPV HR Detection assay (Seegene, Seoul, Republic of Korea), detecting 14 HR-HPVs, and the Allplex™ STI Essential Assay (Seegene), detecting 7 major pathogens causing STIs [Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Trichomonas vaginalis, Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum]. Results: Among 960 included women (mean age 41.3 years), technical success was high: 97.7% of samples yielded valid results for HR-HPV and 97.4% for STIs. Sample stability at ambient temperature eliminated cold-chain requirements. Overall, 17.2% of women were positive for HR-HPV and 26.7% for an STI. The most frequent genotypes were HPV-68 (3.0%), HPV-16 (2.9%), and HPV-31 (2.3%); Ureaplasma parvum (24.0%) was the most prevalent bacterial pathogen. The 18–29 age group exhibited the highest risk for HR-HPV (22.2%) and STIs (36.8%). Multivariate analysis revealed strong biological associations: Chlamydia trachomatis was independently associated with overall HR-HPV (aOR: 4.52; 95% CI: 1.26–16.11) and multiple HR-HPV infections (aOR: 13.96; 95% CI: 3.70–52.64). Mycoplasma hominis and Ureaplasma species were also independently associated with HR-HPV (aOR: 1.83 and 1.67, respectively) or nonvaccine types (aOR: 2.75 and 5.03, respectively). Conclusions: Veil-based self-sampling combined with digital logistics is highly feasible, scalable, and overcomes geographical barriers. The marked association between Chlamydia trachomatis, Mycoplasma hominis, Ureaplasma species, and HR-HPV strongly advocates for integrated molecular co-testing models in public health screening programs.
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