Laser Interferometry of Single Virus Particles Flowing Through Glass Microcapillaries to Detect Novel Coronavirus COVID-19
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- kappa value
研究概览
简要总结
Using Laser light to detect COVID 19 virus particles in deep throat swab / nasal swab samples.
详细描述
The investigators will develop novel primers to detect single virus particles in patient samples. The method involves the absorption of light by single virus particles giving a specific pattern. The investigators will develop the device to create a microdroplet of carrier fluid that is run through the trial device. The investigators will develop novel binding receptors for preferential capture of Coronavirus.
The investigators will review the results of the novel test against the standard diagnostic test and identify virus particles in test negative subjects.
The investigators will isolate the viral rna in test negative subjects and perform sequencing to find novel mutations that are not detected by the current test.
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
盲法说明
The participants and the primary care provider will be masked to the outcome of the test. The test will not be used to determine clinical care and the result of the original diagnostic test will be masked from the outcomes assessor of the novel test under investigation.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical suspicion of coronavirus or staff member having a coronavirus test
排除标准
- •unable to give written informed consent
结局指标
主要结局
kappa value
时间窗: 6 months
level of agreement between novel test and standard test
次要结局
- sensitivity and specificity(unknown this will require a centrally validated test set for known positives and negatives to be available estimated 1 year)