Clinical Validation Study of Point of Care Kenota 1 System and Total Immunoglobulin E Test Kit Using the CWS Method Comparison Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kenota Inc.
- 入组人数
- 411
- 试验地点
- 3
- 主要终点
- Total IgE Value
研究概览
简要总结
The goal of this Method Comparison Study is to compare total IgE results obtained from at least 360 subjects aged less than 80 years old using four different testing arms comprising three types of samples and two testing methods. The main questions it aims to answer are:
- Are the Kenota 1 Devices easy to use by untrained operators at a clinic environment?
- Do tIgE results provided by the Kenota 1 Devices match the results provided by the FDA-cleared Phadia ImmunoCAP System?
Subjects will be asked to donate two fingerstick whole blood samples and one venous blood draw.
详细描述
The Method Comparison Study will compare total IgE results obtained from at least 360 subjects aged less than 80 years old using four different testing arms. comprising three types of samples and two testing methods.
Arm (A): Fresh fingerstick whole blood will be collected and tested on Kenota 1 Devices at three CLIA-Waived sites (CWSs).
Arm (B): Venous plasma will be collected at the CWSs and tested on Kenota 1 Devices at the central lab site.
Arm (C): Venous plasma will be collected at the CWSs and tested on Phadia instruments (ImmunoCAP) at the central lab site.
Arm (D): Venous whole blood will be collected at the CWSs and tested on Kenota 1 Devices at the central lab site.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages <80 years
- •From all Ethnic/Racial backgrounds
排除标准
- •Individuals with skin damage, burns or scars at the site of venipuncture on both arms
结局指标
主要结局
Total IgE Value
时间窗: One day
Tests performed on the Kenota 1 Devices will provide tIgE values in kU/L for each test. These values will be compared directly with the tIgE results produced by the comparator method, Phadia ImmunoCAP system, which are also in kU/L. The Slope, Intercept and Correlation Coefficient will be calculated and used to determine if overall proportional bias of Kenota 1 fresh fingerstick whole blood is less than 10% compared to the comparator method.
次要结局
未报告次要终点