NCT03251261已完成不适用
Illumigene CMV Clinical Trial Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,615
- 试验地点
- 5
- 主要终点
- Qualitative detection of CMV to aid in the diagnosis of CMV
研究概览
简要总结
To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs
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
- — 至 20 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Saliva swab specimens from neonates up to 21 days of age
- •Saliva swab sample placed in a nonnutritive transport medium or in a plastic sterile tube without medium.
- •Flocked-nylon swabs
排除标准
- •Samples other than saliva swab from patients up to 21 days of age.
- •Swabs other than flocked-nylon.
- •Swabs in a viral transport media not defined in the Investigational Use Only package insert
- •Multiple specimens from the same patient.
- •Specimens received in the laboratory in unsatisfactory containers or condition.
结局指标
主要结局
Qualitative detection of CMV to aid in the diagnosis of CMV
时间窗: within 30 days of sample collection
Test each sample for CMV detection
次要结局
未报告次要终点
研究者
研究点 (5)
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