Introduction; Cervical cancer screening is vital for achieving global eradication of this preventable disease. Vaginal self-sampling (VSS) for human papillomavirus (HPV) increases screening uptake, particularly among individuals who dislike traditional methods. Expanding self-sampling options with accurate, acceptable collection devices is essential. The Daye Diagnostic Tampon (DDT) offers an innovative approach, utilising a menstrual tampon to collect vaginal and cervical fluid for HPV screening. This study assessed the diagnostic accuracy of the DDT in detecting high-risk HPV infections, using clinician-collected swabs (CCS) as the reference standard. Methods; In this UK-based study, 262 participants provided CCS, VSS, and DDT samples for HPV testing. Samples were analysed using a clinically validated assay for 14 high-risk HPV types. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the DDT were evaluated against CCS. Invalidity rates - HPV-negative results with negative internal controls were compared across sampling methods. Results; The DDT showed a sensitivity of 82.9% (95% CI: 72.4-89.9%), specificity of 91.6% (86.4-94.9%), and overall accuracy of 89.0% (84.4-92.4%) relative to CCS. McNemar's test showed no significant difference between CCS and DDT results (p = 0.845). Valid result rates were highest for DDT (99.2%), followed by VSS (94.7%) and CCS (90.8%). Conclusion; The DDT demonstrates comparable accuracy to CCS for detecting high-risk HPV and offers superior validity rates. This novel device shows promise as a transformative self-sampling method. Further, complementary research should focus on assessing DDT's clinical performance in detecting HPV associated with the cervical disease endpoints.

The authors have declared no competing interest.

NCT06154239

This study was supported by funding from the European Innovation Council (EIC) awarded to Daye. The EIC had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Ethical approval was obtained from London Camberwell St Giles Ethics Committee (reference 23-LO-0882).

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