Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B

A Prospective Multi-Centre Study of the Respirio Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and Sofia® Influenza A+B Fluorescent Immunoassay (FIA) 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 in detecting Influenza A, when used by subjects, 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 in detecting Influenza B , when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
• assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza A;
• assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza B;
• evaluate the correct interpretation of the Respirio Flu Test results by subjects with Influenza-like illness symptoms;
• evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test;
• evaluate the subjects' comprehension of the Respirio Flu Test labelling; and
• establish the minimum sample weight required to achieve a result with the Respirio Flu Test.

Inclusion Criteria:

• Male and female subjects aged ≥ 1 year;
• Rhinorrhea;
• ≤ 72 hours 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 in 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;
• Subject (or parent/legal guardian) residing at the same residential address as a subject currently enrolled in this study.