Agreement of Antigen Tests on Oral Pharyngeal Swabs or Less Invasive Testing With PCR, for Detecting SARS-CoV-2 in Adults: A Prospective Nationwide Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,000
- 试验地点
- 3
- 主要终点
- Clinical sensitivity and specificity of each antigen test compared to RT-PCR test result.
研究概览
简要总结
To evaluate the analytical and clinical sensitivity and specificity of antigen tests performed as oropharyngeal swabs, outer nasal swabs, saliva swabs or breath tests including self-tests for SARS-CoV-2 towards standard RT-PCR testing.
For each test 200 SARS-CoV-2 positive and 200 SARS-CoV-2 negative individuals previously defined by RT-PCR are tested. When tested an additional RT-PCR test is performed to verify status.
Analytical sensitivity and specificity is determined on 210 SARS-CoV-2 positive samples with known Cq and 100 SARS-CoV-2 negative samples.
30 companies with a total of 55 tests participate in this nationwide study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Age 18 years or over,
- •Capacity to give informed, written consent
- •Be able to cooperate to the additional testing.
排除标准
- •Individuals not fulfilling the inclusion criteria
- •Declining additional oropharyngeal, nasal or saliva swabs.
结局指标
主要结局
Clinical sensitivity and specificity of each antigen test compared to RT-PCR test result.
时间窗: Up to 3 days after first initial positive COVI-19 RT-PCR test
Performance is compared for each antigen test in relation to oropharyngeal RT-PCR samples collected simultaneously
Analytical sensitivity and specificity of each antigen test on retrospectively collected SARS-CoV-2 positive and negative samples.
时间窗: 2 months
SARS-CoV-2 positive samples are stratified into subgroups according to Cq by RT-PCR and frozen samples in universal transport medium is tested on each antigen test.
次要结局
- Clinical sensitivity compared to RT-PCR result with the later stratified into low, intermediate and high Cq(Up to 3 days after first initial positive COVI-19 RT-PCR test)
- Agreement between oropharyngeal swabs and tests from other anatomical test locations by RT-PCR.(Up to 3 days after first initial positive COVI-19 RT-PCR test.)
研究者
Uffe Schneider
Principal Investigator.
Hvidovre University Hospital