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临床试验/NCT02968355
NCT02968355已完成不适用

Clinical Evaluation of the FilmArray® Global Fever (GF) Panel

BioFire Defense LLC11 个研究点 分布在 10 个国家目标入组 2,084 人开始时间: 2018年3月26日最近更新:
适应症

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

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

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (11)

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