Diagnostic Accuracy By Providers Study (DAP)

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.

Study Overview

• Status: Completed
• Conditions: Vaginitis
• Intervention / Treatment: Diagnostic test: BDMax Vaginal Panel

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.

• Study Type: Observational
• Enrollment (Actual): 299

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of UPMC/associated community clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women presenting to primary care offices with symptoms of vaginitis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Diagnostic test: BDMax Vaginal Panel; The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions; Other Names: Gram Stain/Nuget Criteria; yeast culture; Trichomonas vaginalis NAAT

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Becton Dickinson Life Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 6, 2017
• Primary Completion (ACTUAL): August 15, 2018
• Study Completion (ACTUAL): August 15, 2018

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (ACTUAL): May 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vaginal Diseases; Vaginitis
• Other Study ID Numbers: PRO17030332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No