NCT01787227已完成不适用
A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel (NxTAG RPP) in Patients With Clinical Signs and Symptoms of Respiratory Tract Infection
Luminex Molecular Diagnostics4 个研究点 分布在 2 个国家目标入组 1,500 人开始时间: 2015年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 4
- 主要终点
- Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each claimed target.
研究概览
简要总结
xTAG RPP assay is a PCR-based assay to detect the presence or absence of viral and bacterial DNA / RNA in clinical specimens (nasopharyngeal swabs).
The objective of this study is to establish diagnostic accuracy of the xTAG RPP.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each claimed target.
时间窗: Within the first year after sample extraction
Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by xTAG RPP.
次要结局
未报告次要终点
研究者
研究点 (4)
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