POCARED Diagnostics, LTD, Field Study Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 40,000
- 试验地点
- 5
- 主要终点
- Agreement
研究概览
简要总结
This study is designed to compare the performance of the P-1000 System, POCARED's Rapid Diagnostic System which uses optical fluorescence analysis, to standard methods of uropathogen quantification and identification.
详细描述
This study will be conducted at 5 sites, 4 in the United States and 1 site in Israel. 40,000 clinical specimens will be included and assessed by the laboratories using standard reference methods and the P-1000.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Samples arriving in the laboratory for urine culture
排除标准
- •Samples <=2mL
- •Specimens stored at room temperature for more than 2 hours (unless a preservative is used)
- •Specimens refrigerated for more than 24 hours
- •Specimens requesting low count urine culture (<100,000 CFU/mL [colony forming units per milliliter])
- •Bloody specimens
结局指标
主要结局
Agreement
时间窗: 6 months
Agreement of the POCARED quantification and identification compared with standard methods.
Sensitivity
时间窗: 6 months
Sensitivity of the POCARED quantification and identification compared with standard methods.
Specificity
时间窗: 6 months
Specificity of the POCARED quantification and identification compared with standard methods.
次要结局
未报告次要终点