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Validation study of vaginal dry swabs using the Xpert HPV test for human papillomavirus diagnosis

Validation study of vaginal dry swabs using the Xpert HPV test for human papillomavirus diagnosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN83050913
Enrollment
150
Registered
2015-10-06
Start date
2015-03-04
Completion date
Unknown
Last updated
2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human papillomavirus infection Infections and Infestations

Interventions

Women will be invited to perform two samplings for HPV testing. Women will firstly be asked to perform a Self-HPV using a dry swab (S-DRY) and then the physician or nurse will perform a cervical colle

Sponsors

University Hospitals of Geneva (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Attending colposcopy clinic 3. Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF)

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Previous hysterectomy

Design outcomes

Primary

MeasureTime frame
Agreement between the S-DRY and dr-WET samples concerning HPV types and HPV positivity will be measured using the kappa statistic (?).

Secondary

MeasureTime frame
1. Sensitivity and specificity will be calculated for each method, using the cobas HPV test results as reference. Cytological results will also be used as a reference. 2. We will also analyze invalid test results using the Xpert HPV test and the delay between self collection and HPV analysis

Countries

Switzerland

Contacts

Public ContactRosa Catarino

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026