Bacterial VaginosisNCT06975436

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

An observational study of Bacterial Vaginosis and Candida Vaginitis, run by Hoffmann-La Roche at 10 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 14 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Bacterial Vaginosis, Candida Vaginitis
What is being tested?: cobas® BV/CV test, BD Max™ Vaginal Panel and Cepheid Xpert Xpress MVP
How many people: 738 participants
Where: 10 sitesin 3 countries
Study dates: 30 Dec 2024to 30 Jun 2025
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 years and older
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Study population: The intended use population will be a minimum of 500 symptomatic participants with a clinical presentation consistent with vaginitis, vaginosis, or both. A population of a minimum of 100 asymptomatic participants will also be included.

Who may be able to join

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).
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.

Who cannot join

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.

Show all 9Show fewer

Asymptomatic participants who do not have any signs or symptoms consistent with vaginitis, vaginosis, or both, as described above.
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.

Trial locations and contacts

10 sites in 3 countries.

Country

City, postcode or hospital

10 sites in 3 countries

United States8 sites

Planned Parenthood Gulf Coast
Houston, Texas, 77023
Altus Research
Lake Worth, Florida, 33461
Red Rocks OBGYN
Lakewood, Colorado, 80228
Matrix Clinical Research
Los Angeles, California, 90057-4103
Eastern Carolina Women's Center
New Bern, North Carolina, 28562
M3 Wake Research - San Diego at Convoy
San Diego, California, 92111
Washington University
St Louis, Missouri, 63110
Unified Women's Clinical Research/Lyndhurst
Winston-Salem, North Carolina, 27103

Other trials in United States

Bulgaria1 site

Diagnostic Consultative Center "Ascendent" Ltd.
Sofia, 1202

Other trials in Bulgaria

Switzerland1 site

Centre Hospitalier Universitaire Vaudois (Chuv)
Lausanne, 1011

Other trials in Switzerland

About this study

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

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.

Conditions: Bacterial Vaginosis, Candida Vaginitis
Being tested: cobas® BV/CV test, BD Max™ Vaginal Panel, Cepheid Xpert Xpress MVP, Hologic Aptima BV Assay
Medical subject headings: Vaginosis, Bacterial, Candidiasis, Vulvovaginal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cobas® BV/CV testDiagnostic 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 PanelDiagnostic test
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 MVPDiagnostic test
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 AssayDiagnostic test
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.

Study groups in NCT06975436
Study group	Role	What they receive
Symptomatic Participants		Not described Receives: Diagnostic Test: cobas® BV/CV test; Diagnostic Test: BD Max™ Vaginal Panel; Diagnostic Test: Cepheid Xpert Xpress MVP; Diagnostic Test: Hologic Aptima BV Assay
Asymptomatic Participants		Not described Receives: Diagnostic Test: cobas® BV/CV test

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Sensitivity of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status
The sensitivity of a diagnostic test is the percentage of true positive (TP) tests out of all patients with a condition. It is calculated as follows: 100% x (TP)/(TP + false negatives (FN)). The BV test results will be compared with the patient infection status (PIS) established by using 3 Food and Drug Administration (FDA)-cleared commercial assays. The CV test results will be compared with the PIS established by using selective culture and MALDI-TOF.
Measured: Day 1
Clinical Specificity of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status
The specificity of a diagnostic test is the percentage of true negative (TN) tests out of all patients who do not have a condition. It is calculated as follows: 100% x (TN)/(TN + false positives (FP)). The BV test results will be compared with the patient infection status (PIS) established by using 3 FDA-cleared commercial assays. The CV test results will be compared with the PIS established by using selective culture and MALDI-TOF.
Measured: Day 1
Positive Predictive Value of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status
The positive predictive value of a diagnostic test is the percentage of true positive (TP) tests out of all of the positive findings. It is calculated as follows: 100% x (TP)/(TP + FP). The BV test results will be compared with the patient infection status (PIS) established by using 3 FDA-cleared commercial assays. The CV test results will be compared with the PIS established by using selective culture and MALDI-TOF.
Measured: Day 1
Negative Predictive Value of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status
The negative predictive value of a diagnostic test is the percentage of true negative (TN) tests out of all of the negative findings. It is calculated as follows: 100% x (TN)/(TN + FN). The BV test results will be compared with the patient infection status (PIS) established by using 3 FDA-cleared commercial assays. The CV test results will be compared with the PIS established by using selective culture and MALDI-TOF.
Measured: Day 1

Secondary outcomes (2)

Equivalency of the cobas® 5800 System and the cobas® 6800/8800 Systems: Clinical Sensitivity of the cobas® BV/CV Test for Detecting the Presence of BV and/or CV
The sensitivity of a diagnostic test is the percentage of true positive (TP) tests out of all patients with a condition. It is calculated as follows: 100% x (TP)/(TP + false negatives (FN)). The BV test results obtained with each cobas® system will be compared with the patient infection status (PIS) established by using 3 FDA-cleared commercial assays. The CV test results obtained with each cobas® system will be compared with the PIS established by using selective culture and MALDI-TOF.
Measured: Day 1
Equivalency Between the cobas® 5800 System and the cobas® 6800/8800 Systems: Clinical Specificity of the cobas® BV/CV Test for Detecting the Presence of BV and/or CV
The specificity of a diagnostic test is the percentage of true negative (TN) tests out of all patients who do not have a condition. It is calculated as follows: 100% x (TN)/(TN + false positives (FP)). The BV test results obtained with each cobas® system will be compared with the patient infection status (PIS) established by using 3 FDA-cleared commercial assays. The CV test results obtained with each cobas® system will be compared with the PIS established by using selective culture and MALDI-TOF.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Dec 202430 Jun 2025

First posted16 May 2025
Study start30 Dec 2024
Primary completion30 Jun 2025
Study completion30 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 738 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06975436
Sponsor's protocol ID: RD006770
Status last verified: Oct 2026
First submitted: 9 May 2025
Last updated: 16 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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