De-identified Residual Sample Collection for the Respiratory Viral Panel on the GenMark Sample to Answer Platform (ARM 1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,487
- 试验地点
- 1
- 主要终点
- Sample collection study only
研究概览
简要总结
Collect de-identified, residual samples to support a clinical trial. Samples may be prospectively or retrospectively collected. Overall Study Objective Obtain clinical performance data to characterize clinical performance of the Respiratory Viral Panel on the GenMark Sample-to-Answer Platform.
详细描述
The purpose of this investigational study is to collect clinical samples to establish the clinical performance characteristics of the in vitro diagnostic (IVD) Respiratory Viral Panel on the GenMark Sample-to-Answer Platform. Data obtained from the samples will be used to support premarket submissions/registrations for this GenMark product. Samples will be aliquotted, characterized by comparator methods and banked until the instrument and assay are available for testing.
Sample collection may be prospective or retrospective. Prospective collection will preserve prevalence. Retrospective collection will be used to obtain sufficient numbers of certain sample types such as where the organism of interest is of low prevalence. The Sponsor will ensure that information identifying samples as prospectively or retrospectively collected is documented.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sample from patients exhibiting signs/symptoms of respiratory viral infection
- •All medical standard-of-care testing requested by the submitting clinician is complete and has been reported to the clinician/requestor.
排除标准
- •Samples that are incorrectly de-identified
结局指标
主要结局
Sample collection study only
时间窗: prospective and retrospective sample collection
This is an IVD Diagnostic study.
次要结局
未报告次要终点