The Use of SG Diagnostics COVID-19 Antigen Rapid Test Kit for Self-testing as a Method for Reduction SARS-CoV-2
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit
研究概览
简要总结
The SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is intended for use with self-collected nasal swab samples in individuals who are suspected of COVID-19. This test utilizes a lateral flow immunoassay technology for the qualitative detection of spike and nucleocapsid protein antigens of SARS-CoV-2 in individuals with known or suspected COVID-19.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (aged ≥ 18 years) volunteers
排除标准
- •Children (aged < 18years)
结局指标
主要结局
Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit
时间窗: within 1 day
Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit
时间窗: within 1 day
Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
次要结局
未报告次要终点