Assessment of the Clinical Performance of the ARROW-FLU System

Inclusion Criteria:

1. The subject may be of any age and either gender.

2. Preliminary assessment of the subject by the Investigator/Designee should be suggestive of influenza virus infection. Subject should present with an influenza-like febrile respiratory illness defined as both

   • Presentation within that last 48 hours of developing a subjective feeling of being feverish and/or a temperature recorded at the clinic within the last 48 hours of greater than or equal to 100.5 F and
   • At least two of the following symptoms: cough, nasal congestion, rhinorrhea, sore throat, headache, myalgia.

3. Written informed consent must be obtained prior to study enrollment:

   1. A subject who is 18 years or older must be willing to give written informed consent and must agree to comply with study procedures.
   2. The legal authorized representative of a subject who is under the age of 18 must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as defined by the clinical site's IRB).

Exclusion Criteria:

1. The subject underwent a nasal wash/aspirate as part of standard-of-care (SOC) testing during this study visit.

2. The subject is undergoing treatment currently or within the past seven (7) days of the study visit with either

   • A nasally-administered influenza vaccine (FluMist)
   • Anti-viral medication, which may include but is not limited to Amantadine (Symmetrel), Rimantadine (Flumadine), Zanamivir (Relenza), Oseltamivir (Tamiflu), or Ribavirin.
3. The subject is currently receiving or has received within the past thirty (30) days of the study visit anu experimental biologic, drug, or device including either treatment or therapy.