Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis
Public ClinicalTrials.gov record NCT06975436. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Cobas® BV/CV Test for Use on the Cobas® 5800/6800/8800 Systems: Clinical Performance and Reproducibility
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06975436
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 738 participants
Conditions and interventions
Conditions
Interventions
- cobas® BV/CV test Diagnostic Test
- BD Max™ Vaginal Panel Diagnostic Test
- Cepheid Xpert Xpress MVP Diagnostic Test
- Hologic Aptima BV Assay Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- 14 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 30, 2024 (Actual)
- Primary completion
- Jun 30, 2025 (Actual)
- Completion
- Jun 30, 2025 (Actual)
- Last update posted
- Oct 16, 2026
2024 – 2025
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Matrix Clinical Research | Los Angeles | California | 90057-4103 | — |
| M3 Wake Research - San Diego at Convoy | San Diego | California | 92111 | — |
| Red Rocks OBGYN | Lakewood | Colorado | 80228 | — |
| Altus Research | Lake Worth | Florida | 33461 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Eastern Carolina Women's Center | New Bern | North Carolina | 28562 | — |
| Unified Women's Clinical Research/Lyndhurst | Winston-Salem | North Carolina | 27103 | — |
| Planned Parenthood Gulf Coast | Houston | Texas | 77023 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06975436, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06975436 live on ClinicalTrials.gov.