Collection and Testing of Human Oral Fluid Samples/VioOne OF Sample Collection Device
试验速览
- 阶段
- 不适用
- 发起方
- Avioq, Inc.
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Presence of Nicotine in Collected Oral Fluid Samples
研究概览
简要总结
The VioOne Oral Fluid Sample Collection Device can be used to collect human oral fluid samples for detection of cotinine using an ELISA cotinine assay.
详细描述
The Study to evaluate the VioOne Oral Fluid Sample Collection Device (herein referred to as VioOne Device) will consist of several sub-studies as described below:
A. Recovery Study
This study will determine the percent recovery of cotinine spiked into the oral fluid of non-smokers collected with the VioOne Sample Collection Device.
- Sample collection
Oral fluid will be collected per the VioOne package insert from five individuals self-reported to be non-smokers. The samples collected will then be individually spiked with cotinine to concentrations of 0, 5, 10, 15 or 25ng/mL. Two sets of each concentration will be prepared. One set will be stored at 2-8°C prior to testing and one set will be shipped per routine shipping conditions and tested upon return. 2. Testing
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •healthy adults (aged 18 or older)
排除标准
- •individuals with significant health problems.
结局指标
主要结局
Presence of Nicotine in Collected Oral Fluid Samples
时间窗: Within one week of sample collection
ELISA assay in comparison with the Mass-spec method will be used to detect the presence of nicotine in the oral fluid samples collected with the VioOne collection device.
次要结局
未报告次要终点