Evaluation of the Levels of C-Reactive Protein, Procalcitonin, and Lactate in a Normal Healthy Population When Tested With the Nanōmix eLab® System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanōmix eLab® System
研究概览
简要总结
The main objective of this clinical study is to determine the normal reference range of the Nanōmix eLab® (eLab) C-Reactive Protein, Procalcitonin and Lactate Assay.
详细描述
The purpose of this clinical study is to determine the normal reference range of the Nanōmix eLab® (eLab) C-Reactive Protein, Procalcitonin and Lactate Assay, whereby collected blood samples are used to characterize the distribution of C-Reactive Protein (CRP), Procalcitonin (PCT), and Lactate (LAC) in a population of healthy subjects. Approximately 4 mL of whole blood will be collected by venipuncture from normal healthy volunteers and tested with the eLab C-Reactive Protein, Procalcitonin, and Lactate assay within 30 minutes of collection. Following the whole blood test, the sample will be spun down to plasma and a plasma sample will be tested on the eLab with the eLab C-Reactive Protein, Procalcitonin, and Lactate assays within 30 min of the whole blood test. Demographic and health information will also be collected from each participant by having them complete a questionnaire. The test results will be collated to establish the normal range (2.5 - 97.5th percentile) for each analyte. The remaining plasma will be frozen and stored at -80° C.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Must be 18 years of age or older
- •Must have provided written informed consent
- •Must self-report as being in good health
排除标准
- •Under the care of a physician and currently receiving any therapy
- •Obesity (BMI > 35)
- •Have had outpatient surgery or been hospitalized in the last 3 months for any reason
- •Known to be pregnant or nursing
- •Engaged in exertion resulting in an estimated HR>120 bpm for > 5 minutes in the last 4 hours
结局指标
主要结局
Normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanōmix eLab® System
时间窗: One timepoint at enrollment
To determine the normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanōmix eLab® System using Li-Heparinized venous whole blood and Li-Heparinized plasma samples from healthy subjects.System using Li-Heparinized venous whole blood and Li-Heparinized plasma samples from healthy subjects.Nanōmix eLab® System.
次要结局
未报告次要终点