Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Diagnostic Test: Ellume Home Flu Test
* Diagnostic Test: ellume.lab Flu A+B Test
* Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
* Diagnostic Test: Viral culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 2 Years

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: Arm<br>Ellume Home Flu Test and ellume.lab Flu A+B Test Upper respiratory tract samples from participants will be tested with: Ellume Home Flu Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and viral culture. | Diagnostic Test: Ellume Home Flu Test<br>* The Ellume Home Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples.<br>Diagnostic Test: ellume.lab Flu A+B Test<br>* The ellume.lab Flu A+B Test is a rapid in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasal swab samples.<br>Diagnostic Test: 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>Diagnostic Test: Viral culture<br>* Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.<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 Ellume Home Flu Test. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 1 day | 
| 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. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 1 day | 
| 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. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 1 day | 
| 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. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 1 day | 
| 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. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 1 day | 
| 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. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 1 day | 
| 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. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 1 day | 
| 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. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 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. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 1day | 
| Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 1 day | 
| Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 1 day | 
| Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu Test. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits. | 1 day | 
| Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test. | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 1 day | 
| Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 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. | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals. | 1 day | 
| Percent of participants who correctly interpret the result of the Ellume Home Flu Test | Agreement between trained staff and participants. Report as a percentage of participants with 96% confidence limits. | 1 day | 
| Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home 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). | 1 day | 
| Scores from questionnaire to assess ease of use and convenience of the ellume.lab Flu A+B 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). | 1 day |