Evaluation of ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41,862
- 试验地点
- 14
- 主要终点
- PRISM Chagas Specificity
研究概览
简要总结
Protocol designed to test blood samples from blood donors of whole blood and blood components using a new investigational screening test (PRISM Chagas) that detects antibody to T. cruzi (Chagas infection). Results will be compared to the current T. cruzi antibody screening assay. Specimens positive with the screening assay will be further tested with a new investigational Chagas confirmatory assay [Enzyme Strip Assay (ESA) Chagas]. Additional specimens collected under separate protocols or sourced from suppliers will also be provided to the clinical sites for testing with PRISM Chagas assay and ESA Chagas.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy donors that have consented to participate in study
排除标准
- 未提供
结局指标
主要结局
PRISM Chagas Specificity
时间窗: 6 months
Total of 16,249 serum and plasma blood donor specimens tested with PRISM Chagas assay during design validation phase. Repeatedly reactive specimens were tested further with a supplemental assay \[radioimmune precipitation assay (RIPA)\].
PRISM Chagas Sensitivity
时间窗: 6 months
Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.
ESA Chagas Specificity
时间窗: 3 months
Preselected US blood donor specimens (330) presumed T cruzi antibody negative negative that were tested only with the investigational ESA Chagas.
ESA Chagas Sensitivity
时间窗: 3 months
Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.
次要结局
- PRISM Chagas Reactivity Serology Positive Specimens(4 months)
- PRISM Chagas Reactivity in Chagas Endemic Population(2 months)
- ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas.(15 months)
- ESA Chagas Sensitivity in Serologically Positive Non-US Specimens(3 months)
- ESA Chagas Testing in Chagas Endemic Population(2 months)