FebriDx® Method Comparison Study Protocol

Inclusion Criteria: * Subject exhibits or reports a new onset measured temperature (oral or tympanic) of greater than or equal to 100.5°F/38°C within 3 days (72 hours) of enrollment or at the visit * Subject has clinical suspicion for Acute Respiratory Infection and presents with at least one (1) of the following new onset symptoms beginning ≤ 7 days of enrollment: runny nose, nasal congestion, sore throat, cough, hoarse voice or shortness of breath 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 of enrollment * 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 or chemotherapeutic 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 full thickness (3rd°)) in the last 30 days * Subject has had major surgery (requiring intravenous anesthesia and/or respiratory assistance) in the last 30 days * Subject has a history of …