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NCT06975436

Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500 symptomatic individuals with a clinical presentation consistent with vaginitis, vaginosis, or both. Additionally, a minimum of 100 asymptomatic individuals will also be enrolled in the study. The cobas® BV/CV assay amplifies and detects the deoxyribonucleic acid (DNA) of pathogens associated with bacterial vaginosis (BV) and candida vaginitis (CV). The BV results will be compared with the patient infection status (PIS) established by using 3 Food and Drug Administration (FDA)-cleared commercial assays, and the CV results will be compared with the PIS established with the use of culture plus MALDI-TOF (matrix-assisted laser desorption/ionization time-of-flight). The primary objective of the clinical performance study is to evaluate the performance (sensitivity and specificity) of cobas® BV/CV to determine the presence of BV and/or CV in the intended use patient population when being tested on cobas® 6800/8800 systems. The secondary objective is to evaluate the equivalency of cobas® BV/CV between the cobas® 5800 system and cobas® 6800/8800 systems.

Official title: Cobas® BV/CV Test for Use on the Cobas® 5800/6800/8800 Systems: Clinical Performance and Reproducibility

Key Details

Gender

FEMALE

Age Range

14 Years - Any

Study Type

OBSERVATIONAL

Enrollment

738

Start Date

2024-12-30

Completion Date

2025-06-30

Last Updated

2026-10-16

Healthy Volunteers

Yes

Conditions

Bacterial Vaginosis Candida Vaginitis

Interventions

DIAGNOSTIC_TEST

cobas® BV/CV test

The cobas® BV/CV test is an automated, qualitative in vitro real-time PCR diagnostic test that detects bacteria and yeast associated with bacterial vaginosis (BV) and candida vaginitis (CV), respectively. The test does not distinguish among the pathogens but can give an overall qualitative result indicating the presence or absence of pathogen(s) associated with BV and/or CV.

DIAGNOSTIC_TEST

BD Max™ Vaginal Panel

This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three comparators in this study for determining BV patient infection status.

DIAGNOSTIC_TEST

Cepheid Xpert Xpress MVP

This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three comparators in this study for determining BV patient infection status.

DIAGNOSTIC_TEST

Hologic Aptima BV Assay

This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three comparators in this study for determining BV patient infection status.

Inclusion Criteria: Inclusion Criteria for Symptomatic Participants: * Symptomatic participants with a clinical presentation consistent with vaginitis, vaginosis, or both; symptoms may include abnormal vaginal discharge, painful or frequent urination, vaginal itching or burning or irritation, painful or uncomfortable intercourse, and/or abnormal vaginal odor. * Participants aged 14 years or older who are willing and able to provide written, informed consent; for pediatric participants, written assent and parent/legal guardian consent, as applicable by the institutional review board/ethics committee (IRB/EC). Inclusion Criteria for Asymptomatic Participants: * Apparently healthy participants aged 14 years or older who are willing and able to provide written, informed consent; for pediatric participants, written assent and parent/legal guardian consent, as applicable by the IRB/EC. Exclusion Criteria: Exclusion Criteria for Symptomatic Participants: * Participants not meeting the above described inclusion criteria will be excluded from the study. * Use of any azole-containing antimicrobial (oral or vaginal) within the 7 days prior to study enrollment. * Prior enrollment in this study. * Use of any lubricants (eg, Replens, RepHresh) within 3 days prior to sample collection * Use of douches, vaginal deodorizers, or other intravaginal products within 3 days prior to sample collection. The use of tampons or pads during menses should not be considered exclusionary criteria. * Contraindication to vaginal swab sampling. * Asymptomatic participants who do not have any signs or symptoms consistent with vaginitis, vaginosis, or both, as described above. Exclusion Criteria for Asymptomatic Participants: * Prior enrollment in this study. * Participants with a clinical presentation consistent with vaginitis, vaginosis, or both; symptoms may include abnormal vaginal discharge, painful or frequent urination, vaginal itching or burning or irritation, painful or uncomfortable intercourse, and/or abnormal vaginal odor.

Locations (10)

Matrix Clinical Research

Los Angeles, California, United States

M3 Wake Research - San Diego at Convoy

San Diego, California, United States

Red Rocks OBGYN

Lakewood, Colorado, United States

Altus Research

Lake Worth, Florida, United States

Washington University

St Louis, Missouri, United States

Eastern Carolina Women's Center

New Bern, North Carolina, United States

Unified Women's Clinical Research/Lyndhurst

Winston-Salem, North Carolina, United States

Planned Parenthood Gulf Coast

Houston, Texas, United States

Diagnostic Consultative Center "Ascendent" Ltd.

Sofia, Bulgaria

Centre Hospitalier Universitaire Vaudois (Chuv)

Lausanne, Switzerland

Clinical Research Directory

Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (10)