跳至主要内容
临床试验/NCT02547636
NCT02547636已完成不适用

Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel

BioFire Diagnostics, LLC6 个研究点 分布在 1 个国家目标入组 1,822 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,822
试验地点
6
主要终点
Clinical specificity of the FilmArray NGDS Warrior Panel

研究概览

简要总结

This study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel.

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 (prospectively collected via informed consent):
  • Adult subject has a recorded or self-reported fever within the previous 24 hours
  • Subject provides informed consent prior to enrollment and specimen collection
  • Subject has not previously provided a whole blood specimen for this study
  • Whole blood (residual)
  • Whole blood (in EDTA) submitted to laboratory for standard of care testing
  • Specimen is not from an individual with a specimen previously enrolled in the study
  • Positive Blood Culture:
  • Culture was detected as positive by an automated blood culture system
  • Culture is not from a patient previously enrolled in the study
  • Negative Blood Culture:
  • Culture not detected as positive by an automated blood culture system
  • Culture is not from a patient previously enrolled in the study
  • Specimen was accepted for testing by the respective site's microbiology laboratory
  • Specimen is not from an individual that has a sputum already enrolled in the study

排除标准

  • 未提供

结局指标

主要结局

Clinical specificity of the FilmArray NGDS Warrior Panel

时间窗: 8 months

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 (6)

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