NCT05162547已完成不适用
Multi-Center Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB/RSV/Severe Acute Respiratory Syndrome-CoV-2 Assay on the NeuMoDx™ Molecular Systems
QIAGEN Gaithersburg, Inc1 个研究点 分布在 1 个国家目标入组 2,383 人开始时间: 2022年3月11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
- 2,383
- 试验地点
- 1
- 主要终点
- Positive Percentage Agreement
研究概览
简要总结
To demonstrate the clinical performance of the NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay on the NeuMoDx Systems by determining clinical sensitivity and specificity of the Assay.
详细描述
To evaluate the clinical performance of the NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay on the on the NeuMoDx™ 288 and 96 Molecular Systems, collectively referred to as NeuMoDx Systems. The results of this study will be used to support regulatory registration and product release in the US, Europe and other markets.
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
- •Fresh specimens shall be collected from all comers across the study duration
- •Collected from individuals of any age presenting with influenza-like illness (ILI)
- •Nasopharyngeal (NP) swab specimen obtained using a flexible mini-tip flocked swab and collected into 3 mL Copan® Universal Transport Media (UTM) [Cat. No.305c] or Beckton Dickinson (BD™) Universal Viral Transport (UVT) [Cat. No. 220531]
- •Minimum volume for residual specimen approximately 2 mL
- •Fresh specimens to be tested within 3 days of collection.
- •Fresh specimens to be stored under the recommended stability conditions (2-8°C).
排除标准
- •Required information unable to be obtained from associated medical chart.
- •Specimens not fitting criteria outlined above.
结局指标
主要结局
Positive Percentage Agreement
时间窗: 6 months
positive percentage agreement
次要结局
- Negative Percentage Agreement(6 months)
研究者
研究点 (1)
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