COVID-19 Tests With Saliva Specimens
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- The clinical evaluation of saliva as specimen for COVID-19 molecular test
研究概览
简要总结
Upper respiratory swabs, such as the nasopharyngeal (NP) swab, have so far been major specimen sources used for the SARS-COV-2 molecular test. However, due to the discomfort and invasiveness of NP collection, and the expense of personal protective equipment, alternative sampling sources such as saliva are desired. The purpose of this proposed study is: 1) to examine whether saliva can be used as an specimen for the SARS-COV-2 molecular test; 2) to test if gingival crevicular fluids is a reliable specimen for the SARS-COV-2 antibodies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Persons referred for COVID-19 testing including those with COVID-19 symptoms and/or a suspected SARS-COV-2 infection or undergoing surveillance testing and
- •Is able to give informed consent
- •Is able to understand oral or written instructions, and
- •Is able to mentally and physically perform self-collection of saliva using the provided collection device.
排除标准
- •- Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Employees of Paradigm lab and the assisted living facilities involved in the study
- •Members of other vulnerable populations
结局指标
主要结局
The clinical evaluation of saliva as specimen for COVID-19 molecular test
时间窗: 1 hour
We will evaluate the positive and negative agreement of saliva with nasopharyngeal swab as specimens for COVID-19 molecular test.
次要结局
未报告次要终点