Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis
NCT ID: NCT06975436
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
738 participants
OBSERVATIONAL
2024-12-30
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Symptomatic Participants
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.
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.
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.
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.
Asymptomatic Participants
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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).
* 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.
* 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
* 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.
14 Years
FEMALE
Yes
Sponsors
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Roche Molecular Systems
UNKNOWN
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Countries
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Other Identifiers
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RD006770
Identifier Type: -
Identifier Source: org_study_id
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