Clinical Validation of Novel Malaria Diagnostic Tools for Point-of-Care Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- Clinical performance assessment
研究概览
简要总结
In this study, a prospective evaluation of novel malaria diagnostic tools under development will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria at point-of-care (POC). This study aims to support product development efforts and aims to provide early stage (TLR~5) technology developers with valuable information on performance and basic feasibility data that can help to accelerate development.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 5 years or older
- •Presenting at the study site with symptoms and signs suggestive of malaria
- •Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17)
- •Willing to provide sample at enrolment
排除标准
- •Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines
结局指标
主要结局
Clinical performance assessment
时间窗: up to 6 months
Point estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV, and DOR) of nPOC using nPCR as reference for detecting malaria in patients with symptoms suggestive of malaria
Concordance
时间窗: up to 6 months
Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading
次要结局
未报告次要终点