A Prospective Multi-Centre Study of the Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by ellume.lab Flu A+B Test.
研究概览
简要总结
The primary purpose of the study is to validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to reverse transcriptase polymerase chain reaction (RT-PCR)
Secondary aims are to:
Validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture; Evaluate the participant's satisfaction with the convenience and ease of use of the Ellume Home Flu Test; Evaluate the participant's interpretation of the Ellume Home Flu Test results compared to the interpretation by site staff; Evaluate the operator's satisfaction and ease of use of the ellume·lab Flu A+B 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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants aged ≥ 2 years; and
- •Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation; and
- •Rhinorrhea; and
- •≤ 72 hours from onset of ILI symptoms; and
- •Participant (or parent/legal guardian) capable and willing to give informed consent/assent; and
- •Participant (or parent/legal guardian) able to read and write in English.
排除标准
- •Participants aged < 2 years.
- •Participants who have undergone treatment with Tamiflu (oseltamivir), Relenza (zanamivir) or Symmetral (amantadine) within the previous 7 days;
- •Participants who have been vaccinated by means of an Influenza nasal spray/mist vaccine within the previous 7 days;
- •Participants who have had a nose bleed within the past 30 days;
- •Participants who have had recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
- •Participants currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent.
- •Participants previously enrolled in IE-FLU-AUS-1801;
- •Participants 18 years of age or older unable to understand English and consent to participation;
- •Parent/legal guardian of participants < 18 years of age unable to understand English and consent to participation of child.
结局指标
主要结局
Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by ellume.lab Flu A+B Test.
时间窗: 1 day
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by ellume.lab Flu A+B Test.
时间窗: 1 day
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Ellume Home Flu Test.
时间窗: 1 day
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Ellume Home Flu Test.
时间窗: 1 day
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by ellume.lab Flu A+B Test.
时间窗: 1 day
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by ellume.lab Flu A+B Test.
时间窗: 1 day
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Ellume Home Flu Test.
时间窗: 1 day
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Ellume Home Flu Test.
时间窗: 1 day
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
次要结局
- Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.(1 day)
- Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.(1day)
- Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.(1 day)
- Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.(1 day)
- Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home Flu Test.(1 day)
- Scores from questionnaire to assess ease of use and convenience of the ellume.lab Flu A+B Test.(1 day)
- Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test.(1 day)
- Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test.(1 day)
- Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test.(1 day)
- Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu Test.(1 day)
- Percent of participants who correctly interpret the result of the Ellume Home Flu Test(1 day)