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Large Algorithm Setting and Validation Study

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

Who can join

Ages 18 and older · Women

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

About the study

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.

What is being tested

• Nanopath Vaginitis Assay (diagnostic test)
• BD Max™ Vaginal Panel (diagnostic test)
• Cepheid Xpert® Xpress MVP (diagnostic test)
• Hologic Aptima® BV Assay (diagnostic test)
• Yeast Culture (diagnostic test)

Sponsor: Nanopath, Inc · Participants: 1,000 · Started: Jun 3, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07607470

Locations in the U.S.

Conditions

• Bacterial Infections
• Female Genital Diseases
• Fungal Infections
• Bacterial Vaginosis

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.