FebriDx® Method Comparison Study Protocol

Inclusion Criteria:

• Subject exhibits or reports a new onset measured temperature (oral or tympanic) ofgreater than or equal to 100.5°F/38°C within 3 days (72 hours) of enrollment or atthe visit

• Subject has clinical suspicion for Acute Respiratory Infection and presents with atleast one (1) of the following new onset symptoms beginning ≤ 7 days of enrollment:runny nose, nasal congestion, sore throat, cough, hoarse voice or shortness ofbreath

Exclusion Criteria:

• Subject is unable or unwilling to provide signed, Informed Consent

• Subject is less than 12 years old or over 64 years old

• Subject has a fever that started more than 3 days (> 72 hours) prior to enrollment

• Subject has symptoms of Acute Respiratory Infection that started > 7 days ofenrollment

• Subject is receiving interferon therapy (e.g. MS, HIV, HBV, HCV) in the last 30 days

• Subject is in an immunocompromised state (e.g. HIV) or taking immunosuppressive orchemotherapeutic medications in the last 30 days (e.g. oral steroids, Methotrexate,Cyclosporine, Antimetabolite chemotherapy, interferon therapy)

• Subject has taken antibiotics or antiviral therapy in the last 14 days

• Subject received a live viral immunization in the last 14 days

• Subject has significant trauma or burns (> 5% total body surface area or fullthickness (3rd°)) in the last 30 days

• Subject has had major surgery (requiring intravenous anesthesia and/or respiratoryassistance) in the last 30 days

• Subject has a history of a myocardial infarction or stroke in the last 30 days