NCT05733559已完成不适用
An Observational Prospective Clinical Study to Assess Clinical Performance of QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 Target in the Intended Use Population and Environment
QIAGEN Gaithersburg, Inc1 个研究点 分布在 1 个国家目标入组 565 人开始时间: 2023年2月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 565
- 试验地点
- 1
- 主要终点
- PPA
研究概览
简要总结
This study will evaluate the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method
详细描述
This multicentre study aims to evaluation the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting with signs and symptoms of a respiratory infection.
- •Consent or assent to be obtained
- •Able to communicate (speak, read and write) in local language, and able to understand and sign the required study documents.
- •Willing and able to provide Nasopharyngeal Swab (NPS) Specimen collected per manufacturer's instructions.
排除标准
- •Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
结局指标
主要结局
PPA
时间窗: 8 weeks
positive percentage agreement
NPA
时间窗: 8 weeks
negative percentage agreement
次要结局
未报告次要终点
研究者
研究点 (1)
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