Sample Collection to Evaluate an Investigational Instrument for the Detection of Respiratory Viruses in Nasopharyngeal Swabs

GenMark Diagnostics0 个研究点目标入组 205 人开始时间: 2013年2月最近更新: 2015年12月28日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: GenMark Diagnostics
入组人数: 205
主要终点: Sample collection study only

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this sample collection study is to prospectively collect respiratory viral clinical samples, conduct standard of care comparator testing and archive the collected residual samples for future testing in order to establish the clinical performance characteristics of the investigational instrument.

研究设计

研究类型: Observational
观察模型: Case Control
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•The specimen is a nasopharyngeal swab.
•The specimen is from a pediatric or adult male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long term care facility.
•The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis, and pneumonia.

排除标准

•The specimen is not a nasopharyngeal swab.
•The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.

结局指标

主要结局

Sample collection study only

时间窗: prospective sample collection

次要结局

未报告次要终点

研究者

发起方

GenMark Diagnostics

申办方类型

Industry

责任方

Sponsor

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