NCT05124496暂停不适用
Validation of the HyperDetector Digital Solution Screening Assay for Rapid Screening for Potential SARS-CoV-2 (COVID-19) Infection
HyperSpectral APD1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2020年12月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Specificity
研究概览
简要总结
To evaluate the HyperDetector as a method to rapidly screen SARS-CoV-2
To determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated RT-PCR COVID-19 method using nasal or nasopharyngeal swabs and to separately collected nasal swabs, oral swabs, oral rinse and saliva samples.
To determine the best workflow for using such an assay to reflex suspicious/positive samples to a validated RT-PCR COVID-19 assay.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects at COVID-19 testing site for Rt-PCR test.
排除标准
- •Minors under the age of 5
结局指标
主要结局
Specificity
时间窗: By 12/30/2022
To determine the specificity of the screening assay
Sensitivity
时间窗: By 12/30/2022
To determine the sensitivity of the screening assay
次要结局
未报告次要终点
研究者
研究点 (1)
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