| Title: |
Efficacy and Acceptability of Self-Collected Medical Grade Tampon as a Novel Vaginal Sample Collection Tool for the Detection of HPV and STIs |
| Authors: |
Milanova, Valentina; Lazarova, Iva; Mihaylova, Kalina; Gomes, Michelle; Georgieva, Teodora; Multmeier, Jan |
| Publisher Information: |
Springer Science and Business Media LLC |
| Publication Year: |
2024 |
| Description: |
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 ... |
| Document Type: |
other/unknown material |
| Language: |
unknown |
| DOI: |
10.21203/rs.3.rs-3853448/v1 |
| Availability: |
https://doi.org/10.21203/rs.3.rs-3853448/v1; https://www.researchsquare.com/article/rs-3853448/v1; https://www.researchsquare.com/article/rs-3853448/v1.html |
| Rights: |
https://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.1F6A6ACF |
| Database: |
BASE |