NCT04981769Unknown不适用
POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 主要终点
- Covid-19 PCR test result
研究概览
简要总结
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites.
详细描述
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites using a national laboratory PCR Covid-19 test as reference. This study is following FDA EUA molecular test approval criteria. Study will be conducted in 3 or more geographically diverse clinical sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 125 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects presenting to clinical site for Covid-19 testing. Completion of signed written informed consent process.
排除标准
- •Inability to complete signed written informed consent process. Younger than 2 years of age. Any contraindication to Covid-19 swab testing
结局指标
主要结局
Covid-19 PCR test result
时间窗: 90 minutes
Molecular Covid-19 testing
次要结局
未报告次要终点
研究者
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