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

Human Papillomavirus Infection Clinical Trial

Official title:
Clinical Study to Compare the Performance of Self-collected Vaginal Samples Transported Dry to Those Transported Wet for Detection of hrHPV DNA to Screen for CIN2+ Lesions

Clinical Trial 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 to screen for CIN2+ lesions using LBC as the reference standard.

Clinical Trial 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 to screen for CIN2+ lesions using LBC as the reference standard. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06213051
Study type Observational
Source Foundation for Innovative New Diagnostics, Switzerland
Contact Rita Szekely
Phone +41 22 749 29 32
Email rita.szekely@finddx.org
Status Not yet recruiting
Phase
Start date April 1, 2024
Completion date September 30, 2024
View Details
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