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

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

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.

Sponsors & Collaborators

• Roche Molecular Systems

  collaborator UNKNOWN

• Hoffmann-La Roche

  lead INDUSTRY

Principal Investigators

• Clinical Trials · Hoffmann-La Roche

Eligibility

Min Age

14 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-12-30

Primary Completion

2025-06-30

Completion

2025-06-30

FDA Device

Yes

Countries

• United States
• Bulgaria
• Switzerland

Study Locations