Vaginitis
Conditions
Brief summary
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
The primary goals of this study are to: 1. 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 2. 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. 3. 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: 1. Being able to describe the patterns of testing among clinicians in community practices providing routine care for women presenting with symptoms of vaginitis. 2. Describe the treatments prescribed for women presenting with vaginitis and how these prescribed treatments are distributed in women with laboratory-confirmed diagnoses.
Interventions
DIAGNOSTIC_TESTBDMax Vaginal Panel
The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions
Sponsors
Becton Dickinson Life Sciences
University of Pittsburgh
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Female, Age 18-40 2. 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). 3. Able and willing to provide verbal consent. 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BV Result Agreement | enrollment | 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 |
| Trichomonas (TV) Result Agreement | enrollment | 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 |
| Yeast Result Agreement | enrollment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patterns of clinician testing | enrollment | Description of the patterns of testing among clinicians in the community practice providing care for women presenting with symptoms of vaginitis |
| Prescribed Treatments | enrollment | Description of the treatments prescribed for women presenting with vaginitis and how these prescribed treatments are distributed in women with laboratory confirmed diagnoses. |
Countries
United States
Outcome results
None listed