Evaluation of the Performance of a Saliva Sample Versus a Nasopharyngeal Sample in the Diagnosis of COVID-19 by RT-PCR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- Detection of SARS-CoV-2 RNA in the saliva sample
研究概览
简要总结
Since December 2019, the world has faced a pandemic of COVID-19, an infectious disease caused by SARS-CoV-2, a virus that emerged in China. The reference diagnosis is based on the search for the SARS-COV-2 genome in the nasopharyngeal sample.
Carrying out this sample requires the competence of a healthcare professional and presents some inconveniences for the tested patient. Because saliva collection is simple, non-invasive, painless and inexpensive, and can be performed by poorly trained personnel, it could be an alternative to the reference nasopharyngeal sample. SARS-CoV2 detection in human saliva could be a potential diagnosis of COVID infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •patient hospitalized at the Amiens CHU in a COVID-19 unit
- •patient seen as outpatient in the area of infectious pathologies for COVID-19 infection
排除标准
- •Patients under 18
- •patients under guardianship or curators
结局指标
主要结局
Detection of SARS-CoV-2 RNA in the saliva sample
时间窗: day 1
Detection of SARS-CoV-2 RNA in the saliva sample
Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results
时间窗: day 1
Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results
次要结局
未报告次要终点