Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24,111
- 试验地点
- 7
- 主要终点
- PRISM HIV O Plus Test Data for Specificity
研究概览
简要总结
To test blood samples from volunteer donors of whole blood and blood components using a new investigational test that detects human immunodeficiency virus (HIV) infection. Results will be compared to the current HIV screening assay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy donors that have consented to study
排除标准
- 未提供
研究组 & 干预措施
ABBOTT PRISM HIV O Plus assay for Specificity
All subjects will have their blood tested by the investigational HIV test.
干预措施: collection of follow-up sample based on PRISM HIV O Plus result (Device)
ABBOTT PRISM HIV O Plus Assay for Sensitivity
Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
结局指标
主要结局
PRISM HIV O Plus Test Data for Specificity
时间窗: 12 months
Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.
PRISM HIV O Plus Test Data for Sensitivity
时间窗: 12 months
Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA).
次要结局
未报告次要终点