In Vitro Diagnostic Study for Supplemental Testing of Anti-HTLV-I/II Reactive Human Blood Specimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,305
- 试验地点
- 1
- 主要终点
- INNO-LIA HTLV I/II Score Testing
研究概览
简要总结
The InnoLIA HTLV I/II Score is an in vitro diagnostic test for confirmation of antibodies to human T-cell lymphotropic virus (HTLV) type I and type II in human blood samples. It is intended as a supplemental test for blood donor samples that are reactive in routine anti-HTLV screening tests. This study will determine if the test is useful for donor counseling purposes.
详细描述
The InnoLIA HTLV I/II Score study consists of three sub-studies. The first sub-study will determine the sensitivity, specificity and accuracy of HTLV type assignment using well-characterized samples from the NIH-funded HTLV Outcomes Study (HOST). The second sub-study will compare automated reading and interpretation of test results with manual reading and interpretation using a sub-set of samples tested in the initial study. The third sub-study allows for use of the InnoLIA HTLV I/II Score as a supplemental test for whole blood and HCT/P donors testing repeatedly reactive with an FDA-approved donor screening test for anti-HTLV-I/II.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects completing a health history evaluation for routine donor screening
- •Subjects willing and able to provide informed consent
- •Subjects testing repeat reactive on a licensed screening test for HTLV antibodies
排除标准
- •Subjects not meeting health history criteria for routine donor screening
- •Subjects unwilling and unable to provide informed consent
- •Subjects testing negative on a licensed screening test for HTLV antibodies
结局指标
主要结局
INNO-LIA HTLV I/II Score Testing
时间窗: January 2016 through May 2016
315 residual donor samples tested
次要结局
未报告次要终点