ClinicalTrials.Veeva

Menu

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

PT Bio Farma logo

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)

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)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems