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

NCT06975436 | Completed FDA Device

• 1 other identifier: RD006770
• Study Type: observational
• Target: 738
• Locations: 3 countries
• Sites: 10

Brief 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.

Conditions

Bacterial Vaginosis; Candida Vaginitis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  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

  Day 1

Study Arms (2)

Symptomatic Participants

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

Diagnostic Test: cobas® BV/CV test

Interventions

cobas® BV/CV test DIAGNOSTIC_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.

Asymptomatic Participants; Symptomatic Participants

BD Max™ Vaginal Panel DIAGNOSTIC_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.

Symptomatic Participants

Cepheid Xpert Xpress MVP DIAGNOSTIC_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.

Symptomatic Participants

Hologic Aptima BV Assay DIAGNOSTIC_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.

Symptomatic Participants

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• Contraindication to vaginal swab sampling.
• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Roche Molecular Systems: collaborator

Study Sites (10)

Matrix Clinical Research

Los Angeles, California, 90057-4103, United States

Location

M3 Wake Research - San Diego at Convoy

San Diego, California, 92111, United States

Location

Red Rocks OBGYN

Lakewood, Colorado, 80228, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Eastern Carolina Women's Center

New Bern, North Carolina, 28562, United States

Location

Unified Women's Clinical Research/Lyndhurst

Winston-Salem, North Carolina, 27103, United States

Location

Planned Parenthood Gulf Coast

Houston, Texas, 77023, United States

Location

Diagnostic Consultative Center "Ascendent" Ltd.

Sofia, 1202, Bulgaria

Location

Centre Hospitalier Universitaire Vaudois (Chuv)

Lausanne, 1011, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal swab specimens

MeSH Terms

Conditions

Vaginosis, Bacterial; Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Candidiasis; Mycoses; Vulvovaginitis; Vulvitis; Vulvar Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: December 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); BU (1); CH (1)