A Prospective Multi-Centre Study of the Ellume.Lab Flu A+B Test and iTreat Flu A+B 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
- 381
- 试验地点
- 16
- 主要终点
- Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test.
研究概览
简要总结
The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture.
The secondary aims are to:
Validate the sensitivity and specificity of the iTreat Flu A+B 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).
Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms.
Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test.
Evaluate the operators' satisfaction with the 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
- 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 participants aged ≥ 18 years: iTreat Flu A+B Test and ellume.lab Flu A+B Test OR aged ≥ 1 and <18 years: ellume.lab Flu A+B Test only; and
- •Fever ≥ 37.8°C (100°F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8°C (100°F) or feeling feverish within 24 hours of presentation; and
- •Rhonorrhea or blocked nose; 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 <1 year.
- •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 have used any investigational device within 30 days preceding informed consent.
- •Participants 18 years of age or older unable to understand English and consent to participation.
- •Parent/legal guardian of Paticipants <18 years of age unable to understand English and consent to participation of child.
- •Participants who have had prior exposure to iTreat Flu A+B Test.
- •participants who have been previously enrolled in the iE-FLU-AUS-1701 study.
研究组 & 干预措施
iTreat Flu A+B Test and ellume.lab Flu A+B Test
Upper respiratory tract samples from participants will be tested with:
iTreat Flu A+B Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); and viral culture.
干预措施: iTreat Flu A+B Test (Diagnostic Test)
iTreat Flu A+B Test and ellume.lab Flu A+B Test
Upper respiratory tract samples from participants will be tested with:
iTreat Flu A+B Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); and viral culture.
干预措施: ellume.lab Flu A+B Test (Diagnostic Test)
iTreat Flu A+B Test and ellume.lab Flu A+B Test
Upper respiratory tract samples from participants will be tested with:
iTreat Flu A+B Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); and viral culture.
干预措施: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) (Diagnostic Test)
iTreat Flu A+B Test and ellume.lab Flu A+B Test
Upper respiratory tract samples from participants will be tested with:
iTreat Flu A+B Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); and viral culture.
干预措施: Viral culture (Diagnostic Test)
结局指标
主要结局
Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test.
时间窗: 1 day
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants positive for influenza A by viral culture, 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 limits.
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test.
时间窗: 1 day
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants negative for influenza A by viral culture, 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 limits.
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B Test.
时间窗: 1 day
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants positive for influenza B by viral culture, 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 limits.
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test.
时间窗: 1 day
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants negative for influenza B by viral culture, 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 limits.
次要结局
- Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by iTreat Flu A+B Test.(1 day)
- Of participants positive for influenza A by RT-PCR, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.(1 day)
- Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test.(1 day)
- Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.(1 day)
- Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test.(1 day)
- Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.(1 day)
- Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test.(1 day)
- Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.(1 day)
- Percent of participants who correctly interpret result of iTreat Flu A+B Test.(1 day)
- Scores from questionnaire to assess ease of use, comfort and convenience of iTreat Flu A+B Test.(1 day)
- Scores from questionnaire to assess ease of use and convenience of ellume.lab Flu A+B Test.(1 day)