NCT02104518已完成不适用
Evaluation of a Point-of-care G6PD Diagnostic Test
PATH1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2014年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Determine concordance between point-of-care tests and spectrophotometric gold standard
研究概览
简要总结
In this study the investigators propose to evaluate the performance of several G6PD testing platforms.
详细描述
In this study we propose to evaluate the performance of several G6PD testing platforms. We will also determine the concordance between point-of-care G6PD tests and the spectrophotometric gold standard. This study will also access the sensitivity and specificity between the point-of-care G6PD tests. This study will take place in Indonesia, specifically in the SW Sumba region. We will enroll 700 volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 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
- 是
入选标准
- •Subjects must be at least five years of age
- •Patient / parental consent
- •Patient willing to allow donated sample to be used in future research
排除标准
- •Patients with severe malaria or other severe illness
- •Patients who received a blood transfusion in the last three months
- •Patients unwilling to allow donated blood to be used in future research
结局指标
主要结局
Determine concordance between point-of-care tests and spectrophotometric gold standard
时间窗: Six months
Percent agreement between the quantitative results of the G6PD tests and the spectrophotometric test.
次要结局
- Determine sensitivity and specificity of the point-of-care G6PD tests against the spectrophotometric gold standard(Six months)
- Measure categorical accuracy of point-of-care G6PD test against by the spectrophotometric gold standard(Six months)
- Define the G6PD-normal and deficient profiles in the SW Sumba population.(Six months)
- Determine concordance between point-of-care G6PD tests and the florescent spot test(Six months)
研究者
研究点 (1)
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