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

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.

Completed

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Key information

Conditions

Human Papilloma Virus Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: COBAS 6800 HPV from Roche Molecular Systems

Primary outcomes

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

Time frame: 0 days

Sensitivity and Specificity of HPV Diagnostic Kita (Bio Farma)

Sponsors and collaborators

Lead sponsor

PT Bio Farma

Industry

Registry information

Official study title

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)

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Nov 1, 2023
Registry last updated: Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed