NCT05092438已完成不适用
An Observational, Retrospective, Clinical Performance 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 595 人开始时间: 2021年10月8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
- 595
- 试验地点
- 1
- 主要终点
- sensitivity
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
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residual specimens of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing
- •Specimen that had not been centrifuged Adequate residual volume (≥400 μl)
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
- •Obvious physical damage of banked residual specimen
- •Repeat specimens from the same subject
结局指标
主要结局
sensitivity
时间窗: 6 weeks
positive percentage agreement
specificity
时间窗: 6 weeks
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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