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Observational Study for Vaginal Infection Diagnosis

This study is looking at a new diagnostic test called the Nanopath Vaginitis Assay for vaginal infections. It aims to see how accurate the Nanopath test is compared to existing FDA-cleared tests like the BD Max™ Vaginal Panel, Cepheid Xpert® Xpress MVP, Hologic Aptima® BV Assay, and yeast cultures. You may be able to join if you are a biologically female participant, at least 18 years old, and have symptoms like abnormal vaginal discharge, itching, burning, irritation, painful intercourse, vaginal odor, or painful/frequent urination. The study will enroll up to 1000 participants to help develop and check the accuracy of the Nanopath assay for diagnosing vaginal infections.

Study design
This is an observational study involving up to 1000 participants. It compares a new diagnostic test to several existing tests.
What's involved
The study involves providing clinician-collected and participant-collected vaginal swab specimens. The record does not specify the number of visits or the total duration of participation.
Compensation
Not stated in the trial record.
Follow-up
The accuracy of the Nanopath Assay for Diagnosis of Vaginal Infections will be measured at 1 day.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07607470

Large Algorithm Setting and Validation Study

Recruiting
Not specifiedAges 18+Observational
Nanopath, Inc
~1,000 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Nanopath Vaginitis AssayBD Max™ Vaginal PanelCepheid Xpert® Xpress MVPHologic Aptima® BV AssayYeast Culture

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections
Measured over 1 day

Conditions

Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Urogenital Disease
Candidiasis
Mycoses
Vulvovaginitis
Vulvar Diseases
Vaginosis, Bacterial

Explore related trials

Bacterial VaginosisCandidiasisVaginitisVulvovaginitis

NCT07607470

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • LSU-CrescentCare Sexual Health Center

    New Orleans, Louisianastudy coordinator listed

    Recruiting

  • Segal Trials

    North Miami, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Anna Kaplan
[email protected]
347-678-6542
Email the study team

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Eligibility criteria

Inclusion

Abnormal vaginal discharge
Vaginal or vulvar itching, burning, or irritation
Painful or uncomfortable intercourse
Vaginal odor
Painful or frequent urination
Previously enrolled in this study
Contraindication to vaginal swab sampling

What this trial measures

  • Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections1 day

    Compare the sensitivity and specificity of the Nanopath assay to NAAT and yeast culture for diagnosing vaginitis