Diagnostic Accuracy By Providers Study

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.

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.