NCT06213051

Comparison of Self-collection Using Dry Compared to Wet Swabs for HPV Detection

Clinical Study to Compare the Performance of Self-collected Vaginal Samples Transported Dry to Those Transported Wet for Detection of hrHPV DNA.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,306 (estimated)
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA LBC as the reference standard.

Detailed description

Self-collected vaginal samples for high-risk human papillomavirus (hrHPV) DNA testing are a promising alternative cervical cancer screening method for women who are reluctant to undergo healthcare provider-collection of cervical samples. Transportation of self-collected vaginal samples using swabs stored in liquid media incur additional costs and might create testing barriers for women. Dry transport of samples has the advantage of lower cost and ease of handling. Evidence on comparisons between self-collected vaginal samples using the dry swab and those transported in liquid media is limited, particularly in low- and middle-income countries (LMICs). The effect of using dry swabs on HPV-DNA detection in LMICs needs to be determined. This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA using LBC and as reference standard.

Conditions

• Human Papillomavirus Infection

Interventions

Type	Name	Description
DEVICE	• COPAN Self-collection FLOQSwabs® (COPAN, Italy)	COPAN swabs evaluated on Roche COBAS and Cepheid Xpert PCRs

Timeline

• Start date: 2024-07-25
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2024-01-19
• Last updated: 2024-07-29