A Prospective Multi-centre Study of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) for the Rapid Detection of Influenza A/B
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,500
- Locations
- 14
- Primary Endpoint
- Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by eLab Flu Test.
Study Overview
Brief Summary
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza A 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 and the eLab Flu Test in detecting Influenza B as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Evaluate the correct interpretation of the Respirio Flu Test by subjects with influenza-like symptoms; Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female subjects aged ≥ 1 year;
- •Rhinorrhea;
- •≤ 5 days 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 English.
Exclusion Criteria
- •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 or eLab Flu Test.
Outcomes
Primary Outcomes
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by eLab Flu Test.
Time Frame: Day 1
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by eLab Flu Test.
Time Frame: Day 1
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Respirio Flu Test.
Time Frame: Day 1
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
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.
Time Frame: Day 1
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Secondary Outcomes
- 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)
- Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by eLab Flu Test.(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)
- Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by eLab Flu Test.(Day 1)
- Percent of participants who correctly interpret result of Respirio Flu Test.(Day 1)
- Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test.(Day 1)