NCT02461576已完成不适用
Clinical Evaluation of the Xpert® HIV-1 VL: A Method Comparison Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cepheid
- 入组人数
- 966
- 主要终点
- Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects
研究概览
简要总结
Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •HIV-1 seropositive adults using an FDA approved method
- •At least 18 years of age or older
- •Informed consent, if applicable
排除标准
- •Subject is less than 18 years of age
- •Previously enrolled in this study
- •Samples not collected according to the procedure
结局指标
主要结局
Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects
时间窗: 1 day (A single time point)
This study is a comparative analysis of HIV-1 RNA quantitation between Xpert HIV-1 VL to another FDA approved test. A single time point (cross-sectional) from each of at least 300 subjects with HIV-1 RNA quantitation within the dynamic range of both assays will be used in regression models to assess performance of the Xpert HIV-1 VL in comparison to the other FDA approved test.
次要结局
未报告次要终点
研究者
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