Symphony IL-6 Reference Range Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- IL-6 Reference Range Study
研究概览
简要总结
Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment as a point-of-care (POC) device.
The objective of this study is to establish a reference range for Symphony IL-6 in a cohort of apparently healthy individuals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is willing and able to provide informed consent
- •> 18 years of age
- •Whole blood specimen collected in EDTA anticoagulant tubes
- •Minimum volume of 100µL for Symphony IL-6 testing
- •Specimen is available for testing within 12 hours from collection
- •C-Reactive Protein (CRP) < 10 mg/L
排除标准
- •Subjects presenting with a fever
- •Subjects with a diagnosis of COVID-19 or other respiratory illness at the time of collection
- •Subjects otherwise self-reported as unhealthy
- •Hemolyzed specimens
结局指标
主要结局
IL-6 Reference Range Study
时间窗: Specimen is tested within 12 hours from collection
Establishment of the interleukin-6 concentration in whole blood samples from healthy individuals.
次要结局
未报告次要终点