FebriDx® Method Comparison Study Protocol

A prospective, multi-center, blinded observational study to demonstrate that the FebriDx test meets the CLIA statutory criteria for waiver by providing sufficient assurance that the addition of a new operator population (untrained) and environment of use (waived) will not adversely impact the performance or safety of the test.

The study aims to:

• Demonstrate that FebriDx® Test is accurate and the operator can perform the test with a negligible risk of erroneous result.
• As a secondary objective, ease-of-use objective data and subjective feedback relating to the device and its operator interface will be collected at the end of the study and assessed for comparability.

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 a myocardial infarction or stroke in the last 30 days