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| Name | Class |
|---|---|
| Becton Dickinson Life Sciences | UNKNOWN |
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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.
The primary goals of this study are to:
The secondary goals of this study include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| women presenting with vaginitis symptoms | Women with vaginitis seeking routine care will be approached to have five additional swabs collected during their pelvic exam
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BDMax Vaginal Panel | Diagnostic Test | The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions |
|
| 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 |
| 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 |
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Inclusion Criteria:
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.
Women
Women presenting to primary care offices with symptoms of vaginitis
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| Name | Affiliation | Role |
|---|---|---|
| Sharon L Hillier, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital of UPMC/associated community clinics | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32350529 | Derived | Hillier SL, Austin M, Macio I, Meyn LA, Badway D, Beigi R. Diagnosis and Treatment of Vaginal Discharge Syndromes in Community Practice Settings. Clin Infect Dis. 2021 May 4;72(9):1538-1543. doi: 10.1093/cid/ciaa260. |
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| ID | Term |
|---|---|
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Description of the treatments prescribed for women presenting with vaginitis and how these prescribed treatments are distributed in women with laboratory confirmed diagnoses.
| enrollment |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |