NCT01084954已完成不适用
Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
研究概览
简要总结
Validate a simple and cost-effective Nucleic Acid Test for HIV Detection in order to develop a rapid, highly sensitive and specific, one-stage test for the diagnosis of HIV infection. Blood samples collected will be assayed using the BioHelix Corporation helicase-dependent amplification or the Cepheid Xpert HIV-1 Quant Assay. A false negative or false positive rate of >1.0% would make this test unacceptable as a screening test for HIV viremia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current patient in the Medical Faculty Associates Infectious Diseases (ID) clinic with known HIV infection
- •Suspected to be viremic at the time of their clinic visit based on history and/or current symptoms
- •Able to provide informed consent
- •18 Years or older
排除标准
- •Patient unable to provide informed consent.
- •Pregnancy
结局指标
主要结局
Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
时间窗: Participation will last 1 hour for subjects to consent and provide a single blood sample.
A false negative or false positive rate of \> 1.0% would make this test unacceptable as a screening test for HIV viremia.
次要结局
未报告次要终点
研究者
研究点 (1)
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