NCT07489846已完成不适用
Clinical Evaluation of the Xpert® Expanded Respiratory Panel on the GeneXpert® System Using Nasopharyngeal Swab Specimens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cepheid
- 入组人数
- 3,200
- 试验地点
- 1
- 主要终点
- Xpert test compared to comparator(s) tests
研究概览
简要总结
A multi-site observational all-comers study that will be conducted at geographically diverse sites within the United States
详细描述
Prospectively collected Nasopharyngeal swab specimens will be collected from consented individuals with signs and symptoms of respiratory tract infection at a single timepoint
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
- 否
入选标准
- •NPS specimen from participant who presents with signs and symptoms of RTI
- •NPS specimen collected in commercially available UTM/VTM only
排除标准
- •NPS specimen collected from a participant previously enrolled in this study
- •Principal Investigator feels the participant is not suitable to participate in the study
结局指标
主要结局
Xpert test compared to comparator(s) tests
时间窗: Clinical Performance assessed on specimens collected at Baseline
Evaluating the clinical performance (PPA and NPA) of Xpert ERP relative to comparator(s)
次要结局
未报告次要终点
研究者
研究点 (1)
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