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. 2025 Mar 26;25(1):141.
doi: 10.1186/s12905-025-03652-z.

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

Valentina Milanova #  1 , Iva Lazarova #  1 , Kalina Mihaylova #  1 , Michelle Gomes  2 , Teodora Georgieva  1 , Jan Multmeier  3
Affiliations

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

Valentina Milanova et al. BMC Womens Health. .

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.

Keywords: Acceptability; Cervical cancer; Diagnostic accuracy; HPV; STI; Self-collection; TMA; Tampon.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study was conducted in compliance with ethical guidelines and principles established by the ICH Guideline for Good Clinical Practice & Declaration of Helsinki and Bulgarian Health Law. The research protocol was reviewed and approved by Ascendent Medical Center, Bulgaria before data collection commenced. All necessary measures were taken to ensure the protection of the rights, dignity, and well-being of the participants involved. Prior to participation, informed consent was obtained from all individuals included in this study. Participants were provided with a detailed explanation of the study objectives, procedures, potential risks and benefits, and their right to withdraw from the study at any point without consequences. Furthermore, they were assured of the confidentiality and anonymity of their personal information. To protect the privacy and confidentiality of the participants, all data collected during this study was coded and stored securely. Any identifying information was removed or anonymized to maintain the privacy of the participants. Only authorised researchers had access to the data, and the information obtained was solely used for the purposes of this study. This research adheres to the principles outlined in the ICH Guideline for Good Clinical Practice & Declaration of Helsinki. We recognise the importance of ethical considerations in research and strive to conduct studies that contribute to knowledge while respecting the rights and well-being of the participants involved. Consent for publication: Annes Day LTD consents to the publication of the study “Efficacy and Acceptability of Self-Collected Medical Grade Tampon as a Novel Tool for Vaginal Sample Collection Tool for the Detection of HPV and STIs.” Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Workflow for the clinical step of the study
Fig. 2
Fig. 2
Structure of the tampon and dimensions of the final device, enclosed in the applicator of the tampon as well as its raw materials
Fig. 3
Fig. 3
Negative and Positive results for HPV in tampons collected in TP Vial and APTIMA Tube vs TP Vial and APTIMA Tube alone
Fig. 4
Fig. 4
Negative and Positive results for Bacterial Vaginosis(BV) in tampons collected in TP Vial and APTIMA Tube vs TP Vial and APTIMA Tube alone
Fig. 5
Fig. 5
Negative and Positive results for AC2 in tampons collected in TP Vial and APTIMA Tube vs TP Vial and APTIMA Tube alone
Fig. 6
Fig. 6
Patient Preference for Sample Collection Method. The pie chart shows that 90% of survey respondents preferred self-collected tampon samples over clinician-collected swab samples with a speculum, indicating a strong patient preference for the tampon-based method
Fig. 7
Fig. 7
Distribution of Participant Responses Regarding Sample Collection Methods. This graph shows the distribution of participant responses on a 5-point Likert scale, comparing feelings towards using menstrual tampons and undergoing gynaecological exams for vaginal fluid/cervical tissue sampling. The x-axis represents Likert scale ratings from 1 (very negative) to 5 (very positive), while the y-axis shows the number of respondents for each rating. The graph demonstrates a generally more positive attitude towards using menstrual tampons compared to gynaecological exams
See this image and copyright information in PMC

References

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