Bacterial Infections, Bacterial Infections and Mycoses, Candidiasis, Female Urogenital Diseases, Genital Diseases, Female, Infections, Mycoses, Urogenital Disease, Vaginal Diseases, Vaginitis, Vaginosis, Bacterial, Vulvar Diseases, Vulvovaginitis
Conditions
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.
Detailed description
This is an observational, diagnostic study.
Interventions
DIAGNOSTIC_TESTNanopath Vaginitis Assay
Investigational Device
DIAGNOSTIC_TESTBD 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_TESTCepheid 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_TESTHologic 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_TESTYeast Culture
Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation.
Sponsors
Nanopath, Inc
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections | 1 day | Compare the sensitivity and specificity of the Nanopath assay to NAAT and yeast culture for diagnosing vaginitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Equivalency of Percent Agreement Between Self-Collected and Clinician-Collected Samples Using the Nanopath Assay | 1 day | Compare the performance between clinician-collected samples and self-collected samples using the Nanopath assay for diagnosing vaginitis. |
Countries
United States
Outcome results
None listed