Detection of High-Risk HPV in Urine and Cervical Swab Specimen Using HPV Diagnostic Kit (Bio Farma)
Not Applicable
Completed
- Conditions
- Human Papilloma Virus Infection
- Interventions
- Diagnostic Test: HPV Diagnostic Kit (Bio Farma)
- Registration Number
- NCT06111911
- Lead Sponsor
- PT Bio Farma
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 900
Inclusion Criteria
- Sexually active female aged 20-50 years
- Willing to participate in study and signed the informed consent form.
Exclusion Criteria
- Pregnant women
- History of HIV infection
- On menstruation period
- History of complete HPV vaccination
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cervical Swab Specimen HPV Diagnostic Kit (Bio Farma) - Urine Specimen HPV Diagnostic Kit (Bio Farma) -
- Primary Outcome Measures
Name Time Method Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample 0 days Sensitivity and Specificity of HPV Diagnostic Kita (Bio Farma)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cipto Mangunkusumo Hospital
🇮🇩Jakarta, DKI Jakarta, Indonesia