NCT01112956已完成不适用
Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2: Development of Testing Strategies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,500
- 试验地点
- 3
- 主要终点
- Sensitivity and Specificity using Western Blot as the Gold Standard test
研究概览
简要总结
The purposes of this study are:
- To determine the accuracy of commercially available serologic assays in diagnosing patients with herpes simplex virus type 2 (HSV-2);
- To assess the sensitivity and specificity of the commerical assays using HSV-2 western blot as the "gold standard" in a diverse patient population;
- To develop testing strategies and recommendations for screening asymptomatic populations for HSV-2.
详细描述
The purposes of this study are:
- To determine the accuracy of commercially available serologic assays in diagnosing patients with herpes simplex virus type 2 (HSV-2);
- To assess the sensitivity and specificity of the commerical assays using HSV-2 western blot as the "gold standard" in a diverse patient population;
- To develop testing strategies and recommendations for screening asymptomatic populations for HSV-2.
We will evaluate the assays in diverse populations:
- STD clinic population
- Men who have sex with men, with high prevalence of HIV infection
- Pregnant women
The study will inform the development of testing strategies:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women 16-55 years of age
排除标准
- •Those who refuse to get tested for HIV
结局指标
主要结局
Sensitivity and Specificity using Western Blot as the Gold Standard test
时间窗: Up to 4 months after initial testing
次要结局
- In population with relative low prevalence of HSV-2 infection (e.g. persons <=25 years), whether a combination of tests (i.e. testing algorithm(s)) can increase the positive predictive value to the level of >= 95%(Up to 4 months after initial testing)
研究者
研究点 (3)
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