Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Influenza A, Influenza B

Intervention / Treatment
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* Device: Respirio Flu Test
* Device: eLab Flu Test
* Device: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respirio Flu Test and eLab Flu Test<br>Upper respiratory tract samples from participants will be tested with: Respirio Flu Test; eLab Flu Test; and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) | Device: Respirio Flu Test<br>* The Respirio Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal secretions. The Respirio Flu Test is designed to be simple to use and generates a result within 20 minutes.<br>Device: eLab Flu Test<br>* The eLab Flu Test is an in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasopharyngeal swab samples. The eLab Flu Test generates a result within 10 minutes.<br>Device: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)<br>* Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The reverse transcriptase polymerase chain reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits. | Day 1 | 
| 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. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits. | Day 1 | 
| 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. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits. | Day 1 | 
| 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. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits. | 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. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% 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. | Establish specificity against a gold standard. Report as a percentage of participants with 96% 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 eLab Flu Test. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits. | Day 1 | 
| Percent of participants who correctly interpret result of Respirio Flu Test. | Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits. | Day 1 | 
| Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test. | The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale). | Day 1 |