Large Algorithm Setting and Validation Study

NCT07607470 | Not Yet Recruiting

• 1 other identifier: LAVA Protocol
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections

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

  1 day

Secondary Outcomes (1)

• Equivalency of Percent Agreement Between Self-Collected and Clinician-Collected Samples Using the Nanopath Assay

  1 day

Study Arms (1)

Vaginal Infections (BV, CV, TV)

Diagnostic Test: 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

Interventions

BD Max™ Vaginal Panel DIAGNOSTIC_TEST

This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.

Vaginal Infections (BV, CV, TV)

Cepheid Xpert® Xpress MVP DIAGNOSTIC_TEST

This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.

Vaginal Infections (BV, CV, TV)

Yeast Culture DIAGNOSTIC_TEST

Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation.

Vaginal Infections (BV, CV, TV)

Nanopath Vaginitis Assay DIAGNOSTIC_TEST

Investigational Device

Vaginal Infections (BV, CV, TV)

Hologic Aptima® BV Assay DIAGNOSTIC_TEST

This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.

Vaginal Infections (BV, CV, TV)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The intended use population will be up to 1000 symptomatic participants with a clinical presentation consistent with vaginitis.

You may qualify if:

• 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

You may not qualify if:

• Previously enrolled in this study
• Contraindication to vaginal swab sampling

Sponsors & Collaborators

• Nanopath, Inc: lead

Study Sites (1)

LSU-CrescentCare Sexual Health Center

New Orleans, Louisiana, 70119, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal swab specimens

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Genital Diseases; Vulvitis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 26, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)