Validation Protocol Spartan Cube CYP2C19- Method Comparison
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 425
- 试验地点
- 2
- 主要终点
- % Agreement of test results generated on the Spartan Cube CYP2C19 System and bidirectional sequencing
研究概览
简要总结
The aim of the study is to demonstrate concordance (percent agreement) between results produced by the Spartan CYP2C19 system and bi-directional sequencing. In addition, this study will evaluate the concordance of buccal samples stored prior to running on the Spartan Cube CYP2C19 system and bi-directional sequencing.
详细描述
Sample holding time - two parts
- Sample tested in less than one-hour
a.In the first part, buccal samples will be collected from subjects and tested using the Spartan Cube CYP2C19 system. These samples will be run immediately (within 1 h) after collection from the subject (<1 h sample holding time). All results will be compared to bi-directional sequencing to determine percent agreement. 2. Sample tested greater than 21 hours a.In the second part (sample holding portion), samples will be tested using the Spartan Cube CYP2C19 product. These samples will be run after storage at ambient temperature. All results will be compared to bi-directional sequencing to determine the percent agreement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
盲法说明
Bi-directional sequencing results and Spartan results will not be shared with participants. The investigator will not see the bi-directional sequencing results.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who will provide buccal samples and a saliva sample who have not eaten drank or smoked in the past 30 minutes.
排除标准
- •Participants who have eaten drank or smoked in the past 30 minutes prior to collection.
结局指标
主要结局
% Agreement of test results generated on the Spartan Cube CYP2C19 System and bidirectional sequencing
时间窗: Through study completion; anticipated to be less than 4 months
Determine % agreement across all tests conducted and bi-directional sequencing results
次要结局
未报告次要终点