Detection of High-Risk HPV in Urine and Cervical Swab Specimen Using HPV Diagnostic Kit (Bio Farma)

N/ACompletedNCT06111911

PT Bio Farma900 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

900

Conditions

Human Papilloma Virus Infection

Interventions

HPV Diagnostic Kit (Bio Farma)DIAGNOSTIC_TEST

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample

Sensitivity and Specificity of HPV Diagnostic Kita (Bio Farma)

Time frame: 0 days

Data from ClinicalTrials.gov

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