FebriDx DISRUPT Acute Respiratory Infection Trial in Acute Respiratory Infection: An Evaluation of FebriDx® POC Test

Acute Respiratory Infection Cohort INCLUSION CRITERIA * 1 year of age or older * Exhibit or report of 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 * Clinical suspicion for Acute Respiratory Infection and presents with at least one of the following new onset of symptoms: runny nose, nasal congestion, sore throat, cough, hoarse voice or shortness of breath beginning within 7 days before enrollment Acute Respiratory Infection Cohort EXCLUSION CRITERIA * Incomplete or invalid testing for comparator method * Unwilling to participate * Receiving interferon therapy (e.g. MS, HIV, HBV, HCV) in the last 30 days * 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) * Taking antibiotics or antiviral therapy in the last 14 days * Received a live viral immunization in the last 14 days * Significant trauma or burns (\> 5% total body surface area or full thickness (3rd°)) in the last 30 days * Major surgery (requiring intravenous anesthesia and/or respiratory assistance) in the last 30 days * Chronic fever without associated respiratory symptoms of greater than 7 days * History of ear pain plus an exam consistent with otitis media within the last 14 days * History of a myocardial infarction or stroke in the last 30 days ASYMPTOMATIC COHORT INCLUSION CRITERIA * 1 year of age or older * Absence of infectious signs and symptoms ASYMPTOMATIC COHORT EXCLUSION CRITERIA * Fever greater than or equal to 100.5°F /38°C (oral or tympanic) in last 14 days * Cough * Chills * Dyspnea * Purulent Sputum * Fatigue * Pleuritic Pain * Nasal congestion * Rhinorrhea (runny nose) * Sore throat * Hoarse voice * Earache * Autoimmune or rheumatologic disease (e.g. undifferentiated connective tissue disease, Rheumatoid Arthritis, Systemic Lupus Erythematosus (and subsets of Lupus), Sjögren's syndrome, Systemic Sclerosis, Polymyositis and Dermatomyositis, Wegener's granulomatosis) * Suspected of having any infection * Receiving interferon therapy (e.g. MS, HIV, HBV, HCV) in last 30 days * Immunocompromised state (e.g. HIV) or taking immunosuppressive (e.g. oral steroids, Methotrexate, Cyclosporine, Antimetabolite chemotherapy, interferon therapy) in the last 30 days * Taking antibiotics or antiviral therapy in the last 30 days * Received a live viral immunization in the last 30 days * Significant trauma or burns (\> 5% total body surface area or full thickness (3rd°)) in the last 30 days * Major surgery (requiring intravenous anesthesia and/or respiratory assistance) in the last 30 days * History of a myocardial infarction or stroke in the last 30 days * Chronic bacterial infection or osteomyelitis * Known chronic viral infections such as HIV, HCV, HBV, or CMV * Active tuberculosis * Acute or chronic (greater than 30 days) diarrhea and/or vomiting * Urinary tract symptoms in the last 14 days * Active diarrheal illness within the last 14 days * Active skin, ocular, or neurologic infections * Suspected of having otitis media