Clinical Evaluation of the FilmArray® Global Fever (GF) Panel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,084
- 试验地点
- 11
- 主要终点
- Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel
研究概览
简要总结
This study will evaluate the clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel.
详细描述
The FilmArray Global Fever (GF) Panel, developed by BioFire Defense in collaboration with the U.S. Department of Defense and NIAID, uses an automated, multiplex PCR system to evaluate whole blood samples for 19 pathogens simultaneously in under an hour. Targets of the GF Panel are Chikungunya virus, CCHF virus, dengue virus (serotypes 1-4), Ebolavirus, Lassa virus, Marburgvirus, West Nile virus, Yellow fever virus, Zika virus, Bacillus anthracis, Francisella tularensis, Leptospira spp., Salmonella enterica serovar Typhi and Paratyphi A, Yersinia pestis, Leishmania donovani complex, Plasmodium spp., P. falciparum, and P. ovale/vivax. BioFire Defense is conducting a prospective clinical study to evaluate the sensitivity and specificity of the GF Panel when used to test blood collected from subjects with fever or who have recently had fever. This multi-center study is being conducted at locations around the world.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Whole blood in EDTA (prospectively collected via informed consent)
- •Subject has a recorded or self-reported fever within the past two days.
- •Subject has not participated in the study within the last 30 days.
排除标准
- 未提供
结局指标
主要结局
Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel
时间窗: 18 months
Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay
次要结局
未报告次要终点
