Large Algorithm Setting and Validation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nanopath Vaginitis Assay, BD Max™ Vaginal Panel, Cepheid Xpert® Xpress MVP, Hologic Aptima® BV Assay.
- Who it may be relevant to
- Registry conditions: Bacterial Infections, Bacterial Infections and Mycoses, Infections, Vaginitis. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing
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.
Detailed description
This is an observational, diagnostic study.
Interventions
- Diagnostic test Nanopath Vaginitis Assay
Investigational Device - Diagnostic test BD Max™ Vaginal Panel
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. - Diagnostic test Cepheid Xpert® Xpress MVP
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. - Diagnostic test Hologic Aptima® BV Assay
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. - Diagnostic test Yeast Culture
Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation.
Primary outcome measures
- Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections [Time frame: 1 day]
Secondary outcome measures (1)
- Equivalency of Percent Agreement Between Self-Collected and Clinician-Collected Samples Using the Nanopath Assay [Time frame: 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 2 centers
- Segal Trials — North Miami
- LSU-CrescentCare Sexual Health Center — New Orleans
Identifiers
NCT: NCT07607470 · LAVA Protocol