738
Participants
Start Date
December 30, 2024
Primary Completion Date
June 30, 2025
Study Completion Date
June 30, 2025
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.
Centre Hospitalier Universitaire Vaudois (Chuv), Lausanne
"Diagnostic Consultative Center Ascendent Ltd.", Sofia
Unified Women's Clinical Research/Lyndhurst, Winston-Salem
Eastern Carolina Women's Center, New Bern
Altus Research, Lake Worth
Washington University, St Louis
Planned Parenthood Gulf Coast, Houston
Red Rocks OBGYN, Lakewood
M3 Wake Research - San Diego at Convoy, San Diego
Matrix Clinical Research, Los Angeles
Roche Molecular Systems
UNKNOWN
Hoffmann-La Roche
INDUSTRY