Sensitivity and Specificity of SARS-CoV-2 Rapid Antigen Test Compared to RT-PCR Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,697
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of the rapid antigen test of COVID-19
研究概览
简要总结
This project aims to investigate the sensitivity and specificity of the rapid antigen test compared to RT-PCR test performed on samples from the nasopharynx and the anterior nasal cavity and the oropharynx, respectively.
详细描述
The purpose of the study is to investigate the sensitivity and specificity of correct SARS-CoV-2 test results of nasopharyngeal swabs and swabs swabs from the anterior part of the nose examined by rapid antigen test (Standard Q COVID-19 Ag - test, SD Biosensor INC.) compared with swabs from the oropharynx examined by RT-PCR test among citizens who have booked an appointment for a COVID-19 test in one of Testcenter Denmark's test centers in the Capital Region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •A booked appointment for a COVID-19 test at one of Testcenter Denmark's test centers in the Capital Region
排除标准
- •Previously tested positive for COVID-19
- •Non-fluent in Danish
结局指标
主要结局
Sensitivity and specificity of the rapid antigen test of COVID-19
时间窗: It is expected that the required number of participants can be included during approximately one week after t
次要结局
- Economic analyses(It is expected that the required number of participants can be included during approximately one week after t)
- PCR analysis on nasopharyngeal swabs(It is expected that the required number of participants can be included during approximately one week after t)
研究者
Christian von Buchwald
Professor
Rigshospitalet, Denmark