Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-09 @ 8:30 AM
Study NCT ID:
NCT03151928
Status:
COMPLETED
Last Update Posted:
2018-10-04
First Post:
2017-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Accuracy By Providers Study
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Diagnostic Accuracy By Providers Study
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAP
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: