Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Clinical sensitivity and specificity of the FilmArray ME Panel
研究概览
简要总结
The FilmArray Meningitis/Encephalitis (ME) Panel (hereinafter referred to as FilmArray ME Panel) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residual cerebrospinal fluid samples after routine tests;
- •Samples obtained by lumbar puncture;
- •Sample volume is not less than 0.5 mL;
- •Samples that have not been centrifuged;
排除标准
- •Samples from repeatedly enrolled patients;
- •Samples that have not been preserved as required
结局指标
主要结局
Clinical sensitivity and specificity of the FilmArray ME Panel
时间窗: 6 days upon sample collection
Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay
次要结局
未报告次要终点
研究者
Cao Qing
Director of Infectious Diseases
Shanghai Children's Medical Center