Diagnostic Accuracy By Providers Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-06

Study Completion Date

2018-08-15

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.

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Detailed Description

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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.

Conditions

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Vaginitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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women presenting with vaginitis symptoms

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

BDMax Vaginal Panel

Intervention Type DIAGNOSTIC_TEST

The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions

Interventions

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BDMax Vaginal Panel

The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Gram Stain/Nuget Criteria yeast culture Trichomonas vaginalis NAAT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No