NCT03151928

Diagnostic Accuracy By Providers Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 299 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vaginitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	BDMax Vaginal Panel	The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions

Timeline

• Start date: 2017-07-06
• Primary completion: 2018-08-15
• Completion: 2018-08-15
• First posted: 2017-05-12
• Last updated: 2018-10-04

Locations

1 site across 1 country: United States