Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.

A Prospective Multi-Centre Study of the Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.

The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture.

The secondary aims are to:

Validate the sensitivity and specificity of the iTreat Flu A+B 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).

Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms.

Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test.

Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.

Inclusion Criteria:

• Male and female participants aged ≥ 18 years: iTreat Flu A+B Test and ellume.lab Flu A+B Test OR aged ≥ 1 and <18 years: ellume.lab Flu A+B Test only; and
• Fever ≥ 37.8°C (100°F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8°C (100°F) or feeling feverish within 24 hours of presentation; and
• Rhonorrhea or blocked nose; 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 <1 year.
• 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 have used any investigational device within 30 days preceding informed consent.
• Participants 18 years of age or older unable to understand English and consent to participation.
• Parent/legal guardian of Paticipants <18 years of age unable to understand English and consent to participation of child.
• Participants who have had prior exposure to iTreat Flu A+B Test.
• participants who have been previously enrolled in the iE-FLU-AUS-1701 study.