Overview
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.
Description
This is an observational, diagnostic study.
Eligibility
Inclusion Criteria:
Biologically female participants, ≥ 18 years of age, with at least one of the following symptoms of vaginitis:
- Abnormal vaginal discharge
- Vaginal or vulvar itching, burning, or irritation
- Painful or uncomfortable intercourse
- Vaginal odor
- Painful or frequent urination
Exclusion Criteria:
- 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
