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

PT Bio Farma

Status: Completed

Conditions: Human Papilloma Virus Infection

Treatments: Diagnostic Test: HPV Diagnostic Kit (Bio Farma)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06111911

Protokol-BIO-HPV14-BIOFARMA

Details and patient eligibility

About

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.

Enrollment: 900 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

Urine Specimen

Experimental group

Treatment:

Diagnostic Test: HPV Diagnostic Kit (Bio Farma)

Cervical Swab Specimen

Experimental group

Treatment:

Diagnostic Test: HPV Diagnostic Kit (Bio Farma)