Trials / Completed
CompletedNCT06111911
Detection of High-Risk HPV in Urine and Cervical Swab Specimen Using HPV Diagnostic Kit (Bio Farma)
Detection of High-Risk Human Papilloma Virus in Urine and Cervical Swab Specimens; Comparison Between HPV Diagnostic Kit (Bio Farma) and COBAS 6800 HPV (Roche Molecular Systems)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 900 (actual)
- Sponsor
- PT Bio Farma · Industry
- Sex
- Female
- Age
- 20 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This study is a cross-sectional study to evaluate accuracy of high-risk DNA-HPV testing using HPV Diagnostic Kit (Bio Farma) compared to Standard Kit (COBAS® 6800 HPV from Roche Molecular Systems) RT-PCR based in urine and cervical swab specimens.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | HPV Diagnostic Kit (Bio Farma) | Urine samples (30 ml): collected from each subjects using urine pot. Cervical swab: collected from each subject using cyto brush and stored in special container which preservatives fluid. |
Timeline
- Start date
- 2022-04-01
- Primary completion
- 2022-10-29
- Completion
- 2022-10-29
- First posted
- 2023-11-01
- Last updated
- 2023-11-01
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT06111911. Inclusion in this directory is not an endorsement.