NCT01032902已完成不适用
Study to Establish the Ability of the Chembio Diagnostics Systems, Inc. DPP HIV 1/2 Rapid Test to Qualitatively Detect the Presence of Antibodies Against HIV-1 in Oral Fluid, Whole Blood (Capillary and Venous), Serum and Plasma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,808
- 试验地点
- 5
- 主要终点
- The device detects HIV-1 antibodies in a variety of sample matrices: capillary whole blood, venous whole blood (with EDTA or heparin anticoagulant), oral fluid, serum and plasma (with EDTA or heparin anticoagulant).
研究概览
简要总结
This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid, whole blood (capillary and venous), serum or plasma. This study will assess the DPP® HIV 1/2 Screen assay's ability to detect HIV-1.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be at least 2 years of age (no upper age limit).
- •Must be willing and able to receive post-test counseling, if applicable.
- •Must sign (and be given) a copy of the written Informed Consent form and or Assent form (if applicable).
- •Must be able to sustain fingersticks and venipuncture from the arm or hand only.
排除标准
- •Am in a life threatening condition at the time of enrollment
- •Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.).
- •Have participated or are participating in a clinical trial for an HIV vaccine.
- •Have previously participated in this clinical trial.
结局指标
主要结局
The device detects HIV-1 antibodies in a variety of sample matrices: capillary whole blood, venous whole blood (with EDTA or heparin anticoagulant), oral fluid, serum and plasma (with EDTA or heparin anticoagulant).
时间窗: 20 minutes
次要结局
- The device provides a qualitative screen for the detection of antibodies to HIV-1 compared to an FDA approved HIV-1/2 EIA, with sensitivity and specificity equal to or greater than 98% at the lower 95% confidence interval boundary.(20 minutes)
研究者
研究点 (5)
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