Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 主要终点
- To establish the precision of IB10 sphingotest PCT+ measurements in point-of-care setting with respect to frozen EDTA plasma specimens
研究概览
简要总结
To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings such as emergency rooms or intensive care units, with corresponding procalcitonin measurements obtained in a reference or clinical laboratory using a comparative assay, with respect to the same subset of human EDTA plasma specimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able and willing to provide written informed consent
- •Subject is 18 years of age or older
- •Subject is presenting with symptoms suggestive of bacterial infection
- •Subject is presenting with two or more of the following symptoms suggestive of systemic inflammatory response syndrome (SIRS):
- •Body temperature less than 36°C (96.8°F) or greater than 38°C (100.4°F);
- •Heart rate greater than 90 beats per minute;
- •Respiratory rate greater than 20 breaths per minute, or an arterial partial pressure of carbon dioxide (pCO2) less than 4.3 kPa (32 mmHg);
- •White blood cell count less than 4,000 cells/mm3 (4 x 109 cells/L) or greater than 12,000 cells/mm3 (12 x 109 cells/L);
- •A normal white blood cell count with the presence of greater
- •than 10% immature neutrophils.
排除标准
- •Subjects less than 18 years of age;
- •Subjects who do not present with a minimum of two symptoms suggestive of SIRS, as defined above
- •Subjects unable or unwilling to provide written informed consent
结局指标
主要结局
To establish the precision of IB10 sphingotest PCT+ measurements in point-of-care setting with respect to frozen EDTA plasma specimens
时间窗: 1 day
Point of Care precision Testing
To establish the in vitro stability of EDTA whole blood and plasma speciments with respect to procalitonin concentrations as measured by the of IB10 sphingotest PCT+ test.
时间窗: 1 day
in vitro stability
To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings, with corresponding procalcitonin measurements obtained in a ref or clinical laboratory using a comparative assay, with respect to the same EDTA plasma specimens
时间窗: 1 day
Method comparison
To establish the equivalence of IB10 sphingotest PCT+ measurements in EDTA whole blood and plasma specimens, as obtained in point-of-care settings as defined above
时间窗: 1 day
Method comparison
To establish equivalence of IB10 sphingotest PCT+ measurements in fresh EDTA plasma specimens and frozen EDTA plasma specimens
时间窗: 24 hours
in vitro stability
次要结局
未报告次要终点