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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06111911

Enrollment

900

Registered

2023-11-01

Start date

2022-04-01

Completion date

2022-10-29

Last updated

2023-11-01

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

Conditions

Human Papilloma Virus Infection

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.

Interventions

DIAGNOSTIC_TESTHPV 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample	0 days	Sensitivity and Specificity of HPV Diagnostic Kita (Bio Farma)

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026