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Large Algorithm Setting and Validation Study
Sponsor: Nanopath, Inc
Summary
In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay. The Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.
Official title: A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2026-05-20
Completion Date
2027-01
Last Updated
2026-05-26
Healthy Volunteers
No
Conditions
Interventions
Nanopath Vaginitis Assay
Investigational Device
BD Max™ Vaginal Panel
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
Cepheid Xpert® Xpress MVP
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
Hologic Aptima® BV Assay
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
Yeast Culture
Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation.
Locations (1)
LSU-CrescentCare Sexual Health Center
New Orleans, Louisiana, United States