Diagnostic Accuracy By Providers Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- BV Result Agreement
研究概览
简要总结
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.
详细描述
The primary goals of this study are to:
- 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
- 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.
- 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:
- Being able to describe the patterns of testing among clinicians in community practices providing routine care for women presenting with symptoms of vaginitis.
- Describe the treatments prescribed for women presenting with vaginitis and how these prescribed treatments are distributed in women with laboratory-confirmed diagnoses.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, Age 18-40
- •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).
- •Able and willing to provide verbal consent.
- •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.
- •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.
排除标准
- 未提供
结局指标
主要结局
BV Result Agreement
时间窗: enrollment
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
Trichomonas (TV) Result Agreement
时间窗: enrollment
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
Yeast Result Agreement
时间窗: enrollment
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
次要结局
- Prescribed Treatments(enrollment)
- Patterns of clinician testing(enrollment)
研究者
Sharon Hillier
Professor
University of Pittsburgh