NCT02487173已完成不适用
A Prospective Multi-Centre Study of the Respirio Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and Sofia® Influenza A+B Fluorescent Immunoassay (FIA) for the Rapid Detection of Influenza A/B
Ellume Pty Ltd8 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2015年9月1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
- 83
- 试验地点
- 8
- 主要终点
- Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Respirio Flu Test.
研究概览
简要总结
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
The secondary aims are to:
- validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza B , when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
- assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza A;
- assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza B;
- evaluate the correct interpretation of the Respirio Flu Test results by subjects with Influenza-like illness symptoms;
- evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test;
- evaluate the subjects' comprehension of the Respirio Flu Test labelling; and
- establish the minimum sample weight required to achieve a result with the Respirio Flu Test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged ≥ 1 year;
- •Rhinorrhea;
- •≤ 72 hours from onset of Influenza-like illness symptoms;
- •Subject (or parent/legal guardian) capable and willing to give informed consent/assent.
- •Subject (or parent/legal guardian) able to read and write in English.
排除标准
- •Has undergone treatment with antivirals within the previous 7 days;
- •Has been vaccinated by means of an Influenza nasal spray/mist vaccine within the previous 7 days;
- •Recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
- •Currently enrolled in another clinical trial or used any investigational device within 90 days preceding informed consent;
- •Has had prior exposure to the Respirio Flu Test;
- •Subject (or parent/legal guardian) residing at the same residential address as a subject currently enrolled in this study.
结局指标
主要结局
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Respirio Flu Test.
时间窗: Day 1
Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.
Of participants positive for influenza A by ReverseTranscriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Respirio Flu Test.
时间窗: Day 1
Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.
次要结局
- Percent of participants who correctly interpret result of Respirio Flu Test.(Day 1)
- Weight of sample deposited in Respirio Flu Test.(Day 1)
- Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test.(Day 1)
- Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Respirio Flu Test.(Day 1)
- Percent of participants positive for influenza A by Sofia® Influenza A+B Test and Respirio Flu Test.(Day 1)
- Combine positive and negative agreement of Respirio Flu Test and Sofia® Influenza A+B Test to establish overall agreement. Report as a percentage of participants with 95% confidence limits.(Day 1)
- Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Respirio Flu Test.(Day 1)
- Percent of participants correctly determining eligibility and conditions for use of Respirio Flu Test from scores on a label comprehension questionnaire.(Day 1)
- Percent of participants negative for influenza B by Sofia® Influenza A+B Test and Respirio Flu Test.(Day 1)
研究者
研究点 (8)
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