Diagnostic Accuracy By Providers Study

Study Overview
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Brief Summary
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The validation study is intended to provide comparative data on the diagnosis of vaginal infections as performed in primary care settings versus the diagnosis provided through standard diagnostic testing performed in a reference laboratory. The clinician and lab diagnoses will be compared to those obtained using the BD MAX Vaginal Panel on the BD MAX System.

Detailed Description
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The primary goals of this study are to: Compare the level of agreement of clinician diagnosed bacterial vaginosis (BV) to vaginal swab samples evaluated for BV using Nugent's criteria and the BD MAX Vaginal Panel Compare the level of agreement of clinician diagnosed trichomonas vaginalis (TV) to the laboratory diagnosis of TV identified by quantitative PCR using the GeneXpert system by Cepheid and the BD MAX Vaginal Panel. Compare the level of agreement of clinician diagnosed yeast vaginitis to laboratory diagnosis of yeast identified with culture and the BD MAX Vaginal Panel. The secondary goals of this study include: Being able to describe the patterns of testing among clinicians in community practices providing routine care for women presenting with symptoms of vaginitis. Describe the treatments prescribed for women presenting with vaginitis and how these prescribed treatments are distributed in women with laboratory-confirmed diagnoses.

Official Title
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Diagnostic Accuracy By Providers Study

Conditions
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Vaginitis

Intervention / Treatment
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* Diagnostic Test: BDMax Vaginal Panel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, Age 18-40 Presenting with symptoms of vaginitis; vaginal discharge, vaginal odor, vulvar or vaginal itch, vulvar or vaginal discomfort (i.e. irritation, burning pain or vulvar edema). Able and willing to provide verbal consent. Willingness to undergo all study-related assessments and procedures, including the collection of multiple vaginal swabs, answer questions related to demographic and health information and follow all other study-related procedures. Exclusion: Women who meet any of the following criteria by participant report will be excluded from the study: 1.) Any condition that, in the opinion of the Investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women presenting with vaginitis symptoms<br>Women with vaginitis seeking routine care will be approached to have five additional swabs collected during their pelvic exam vaginal swab for qualitative PCR using the BD Max Vaginal Panel on the automated BDMAX System Vaginal smear for evaluation with Gram's stain and Nuget's criteria Vaginal swab for yeast culture Vaginal swab for Trichomonas vaginalis NAAT Vaginal swab for discrepant analysis testing | Diagnostic Test: BDMax Vaginal Panel<br>* The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions<br>* Other names: Trichomonas vaginalis NAAT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BV Result Agreement | Comparison of the level of agreement of clinician diagnosed BV to vaginal swab samples evaluated for BV using Nugent's criteria and the BD MAX Vaginal Panel | enrollment | 
| Trichomonas (TV) Result Agreement | Comparison of the level of agreement of clinician diagnosed TV to the laboratory diagnosis of TV identified by quantitative PCR using the GeneXpert system by Cepheid and the BD MAX Vaginal Panel | enrollment | 
| Yeast Result Agreement | Comparison of the level of agreement of clinician diagnosed yeast vaginitis to laboratory diagnosis of yeast identified with culture and the BD MAX Vaginal Panel | enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns of clinician testing | Description of the patterns of testing among clinicians in the community practice providing care for women presenting with symptoms of vaginitis | enrollment | 
| Prescribed Treatments | Description of the treatments prescribed for women presenting with vaginitis and how these prescribed treatments are distributed in women with laboratory confirmed diagnoses. | enrollment |