An observational study in Bacterial Infections, Bacterial Infections and Mycoses and Infections, sponsored by Nanopath, Inc. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Nanopath, Inc · Observational
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.
240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 350 across 30 observational studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →This is the only study on the registry with Nanopath, Inc as lead sponsor.
Compared within Vaginosis, Bacterial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Bacterial Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The intended use population will be up to 1000 symptomatic participants with a clinical presentation consistent with vaginitis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Biologically female participants, ≥ 18 years of age, with at least one of the following symptoms of vaginitis:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Investigational Device
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.
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.
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.
Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation.
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
Time frame: 1 day
Equivalency of Percent Agreement Between Self-Collected and Clinician-Collected Samples Using the Nanopath Assay
Compare the performance between clinician-collected samples and self-collected samples using the Nanopath assay for diagnosing vaginitis.
Time frame: 1 day
Plan to share: No
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