FebriDx® Method Comparison Study Protocol

Launched by LUMOS DIAGNOSTICS · Dec 19, 2024

Keywords

ClinConnect Summary

The FebriDx Method Comparison Study is looking to understand how well the FebriDx test can differentiate between bacterial and non-bacterial respiratory infections, especially when used by people who don’t have any laboratory training. This is important because it could help doctors quickly determine the cause of respiratory symptoms, like a cough or sore throat, in patients. The study is currently recruiting participants between the ages of 12 and 64 who have a fever and respiratory symptoms that started within the last week.

If you or someone you know is interested in participating, you would need to provide consent and meet certain criteria, such as having a recent fever and specific respiratory symptoms. Participants will have the FebriDx test performed by both trained and untrained individuals to see how accurate the results are. It's a unique opportunity to contribute to research that could improve the diagnosis of respiratory infections, and you would be helping to gather important information on this new testing method.

Gender

ALL

Eligibility criteria

• 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