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.
Abnormal vaginal discharge
Vaginal or vulvar itching, burning, or irritation
Painful or uncomfortable intercourse
Vaginal odor
Participants who do not meet the above-described inclusion criteria will be excluded from the study.
Previously enrolled in this study
Contraindication to vaginal swab sampling