NCT02067286已完成不适用
Multi-Center Study of In Vitro Diagnostic Devices for the Detection of Influenza A, Influenza B, and RSV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- IQuum, Inc.
- 入组人数
- 1,642
- 试验地点
- 7
- 主要终点
- Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to an FDA-cleared nucleic acid amplification test
研究概览
简要总结
The objective of this study is to evaluate the clinical sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay when used on the Liat Analyzer to detect the presence or absence of Influenza A, Influenza B, and RSV in a nasopharyngeal swab specimen as compared to an FDA approved NAAT and culture.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients exhibiting 2 or more symptom groups characteristic of influenza and/or RSV at the time of visit or within the past 48 hours:
- •fever of at least 37.8 C (100F)
- •runny or stuffy nose
- •coughing, wheezing or difficulty breathing
- •sore throat, headache, extreme tiredness, or muscle aches
- •infants: decreased activity, irritability, poor feeding
- •Subject who are able to understand and consent to participation; for minors under the age of 18, this includes a parent or legal guardian
排除标准
- •Patients who are under-going anti-viral medication now or within the last 7 days.
- •Patients who received Nasal Spray Flu Vaccine within the last 6 weeks
结局指标
主要结局
Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to an FDA-cleared nucleic acid amplification test
时间窗: 1 day
次要结局
- Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to culture(1 day)
研究者
研究点 (7)
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