Abstract

Introduction Cervical cancer screening is vital for achieving global elimination of this preventable disease. Vaginal self-sampling (VSS) for human papillomavirus (HPV) has the potential to increase screening uptake, particularly among individuals who may be underserved by clinician collection. 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, 260 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, and negative predictive value 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% (CI:86.4–94.9%), and overall accuracy of 89.0% (CI: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 (95.4%) and CCS (90.8%).

Conclusion The DDT demonstrates comparable accuracy to CCS for detecting high-risk HPV. This novel device shows promise as a self-sampling method. Further, complementary research should focus on assessing DDT’s clinical performance in detecting HPV associated with cervical disease endpoints.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT06154239

Funding Statement

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.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

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

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Yes

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Data availability

Both the full study protocol and the study data are available on reasonable request, with requests made to the corresponding author.

AcronymsCCSClinician-Collected SwabsCIConfidence IntervalDDTDaye Diagnostic TamponHPVHuman PapillomavirusPPVPositive Predictive ValueNPVNegative Predictive ValueVSSVaginal Self-Swabs