Clinical Performance Study of the Ultra Influenza A&B Test Using Nasal Swabs for Identifying Subjects Who Are Infected With the Influenza Virus Strain Type A or Type B

Inclusion Criteria:

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

- 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 (1) presentation within the
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 (2) at least two of the following symptoms: cough, nasal congestion,
rhinorrhea, sore throat, headache, myalgia.

- 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 IRB).

Exclusion Criteria:

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

- The subject is undergoing treatment currently and/or within the past 7 days of the
study visit with a nasally administered influenza vaccine (FluMist) or with
anti-viral medication, which may include but is not limited to Amantadine
(Symmetrel), Rimantadine (Flumadine), Zanamivir (Relenza), Oseltamivir (Tamiflu) or
Ribavirin.

- The subject is currently receiving or has received within the past thirty (30) days
of the study visit an experimental biologic, drug or device, including either
treatment or therapy.

- The subject has previously participated in this research study.