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

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

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.

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.