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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Infections (BV, CV, TV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanopath Vaginitis Assay | Diagnostic Test | Investigational Device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
Biologically female participants, ≥ 18 years of age, with at least one of the following symptoms of vaginitis:
Exclusion Criteria:
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The intended use population will be up to 1000 symptomatic participants with a clinical presentation consistent with vaginitis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LSU-CrescentCare Sexual Health Center | New Orleans | Louisiana | 70119 | United States |
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Vaginal swab specimens
| 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. |
|
| 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. |
|
| 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. |
|
| Yeast Culture | Diagnostic Test | Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation. |
|
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D000091642 | Urogenital Diseases |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D014848 | Vulvovaginitis |
| D014845 | Vulvar Diseases |
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091662 | Genital Diseases |
| D014847 | Vulvitis |
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