NCT05155553已完成不适用
An Observational Clinical Performance Evaluation Study Testing Residual Specimens of Cerebrospinal Fluid Obtained by Lumbar Puncture From Meningitis/Encephalitis Subjects Using the QIAstat-Dx® Meningitis/Encephalitis Panel
QIAGEN Gaithersburg, Inc1 个研究点 分布在 1 个国家目标入组 1,524 人开始时间: 2022年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,524
- 试验地点
- 1
- 主要终点
- PPA
研究概览
简要总结
Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.
详细描述
This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residual specimens (minimum 500μL) of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing Specimen that have not undergone more than 3 freeze/thaw cycles.
排除标准
- •Specimens not fitting criteria outlined above.
- •CSF obtained from an external ventricular drain or shunt source.
- •Lack of clear subject identification or label on residual banked CSF specimen.
- •Specimen has been centrifuged.
- •Obvious physical damage of banked residual specimen.
- •Repeat specimens from the same subject.
结局指标
主要结局
PPA
时间窗: 6 months
positive percentage agreement
NPA
时间窗: 6 months
negative percentage agreement
次要结局
未报告次要终点
研究者
研究点 (1)
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