Large Algorithm Setting and Validation Study

A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing

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.

This is an observational, diagnostic study.

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