QuickVue Influenza A + B Test Field Study

The objective of this study is to demonstrate an improved clinical performance of the visually read QuickVue Influenza A+B test with nasal and nasopharyngeal swab specimens. Clinical performance will be based on comparison of QuickVue results to either cell culture or an FDA-cleared molecular test at one or more Reference Laboratories.

Inclusion criteria

Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza. They must meet the following criteria to be eligible for enrollment:

• Male or Female of all ages (with appropriate consent).
• The subject must have had of a fever, ≥ 37.8º C (100º F), within the last two days.
• Must also be currently exhibiting one or more of the following symptoms characteristic of influenza-like-illness (ILI).

• Nasal congestion
• Rhinorrhea
• Sore throat
• Cough
• Headache
• Myalgia
• Malaise

Exclusion criteria

• 1. Has undergone treatment with anti-influenza antivirals within the previous 7 days, to include but not be limited to, Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.

• Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.

• Unable to understand and consent to participation; for minors this includes parent or legal guardian.