Efficacy and acceptability of a self-collected medical grade tampon as a novel vaginal sample collection tool for the detection of HPV and STIs.

Abstract

Objective: Cervical cancer remains a significant health concern, particularly in low-income and middle-income countries (LMICs). This study aims to compare the efficacy and suitability of a self-collected tampon for the detection of human papillomavirus (HPV) and sexually transmitted infections (STIs) using qualitative TMA-based assays (Transcription Mediated Amplification; APTIMA® HPV, APTIMA® Combo 2 (CT/NG; AC2 from now on) and APTIMA®Bacterial Vaginosis (BV from now on). Additionally, we assess the acceptability of tampons as a self-collection tool.

Methods: A cohort of 75 female participants aged 18-54 years was recruited through female-focused social networks. Participants provided informed consent and underwent both Health Care Workers (HCW-collected) and self-collected sample collection using the Daye Diagnostic Tampon. Samples were stored in ThinPrep Vials (TP Vial) or Aptima® Multitest Swab Collection Kit (APTIMA®) solutions. HPV and STI testing were performed using TMA-based assay on the fully automated Panther® Platform. Acceptability was assessed through a questionnaire with Likert-scale responses.

Results: The study involved 60 participants who completed the study (80% of recruited participants). The self-collected tampons showed sensitivity and specificity of 66.67% and 90.74% (when rinsed in TP Vial) and 83.33% and 85.42% (when rinsed in APTIMA®) for HPV detection, respectively. For bacterial vaginosis (BV) detection, the tampons exhibited sensitivity and specificity of 100.0% and 96.43% (TP Vial) and 88.89% and 98.04% (APTIMA), respectively. For detection of chlamydia and gonorrhoea (AC2), the sensitivity and specificity were 100.00% and 100.0% (TP Vial) and 100.00% and 98.31% (APTIMA), respectively. Participants expressed a preference for tampon self-collection over HCW-collected swabs (90%).

Conclusion: Self-collected tampons demonstrated promising diagnostic accuracy to HCW-collected swabs for HPV and STI detection. The tampon self-collection method was well-accepted and preferred by participants, suggesting its potential as an alternative screening tool, particularly in low-resource settings. Further research with larger and more diverse populations is recommended to validate these findings and inform tampon-based self-collection programs for cervical cancer screening. Randomised controlled trials and comparisons with gold standard methods would enhance validation.