Description

Introducing FebriDx®, the only test of it’s kind. FebriDx is a new rapid point-of-care test to aid in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial etiology

Intended use

FebriDx is intended to be used in urgent and emergency care settings. FebriDx offers rapid, point-of-care results that aid in diagnosing a bacterial infection, which could have a direct impact on the spread of resistant bacteria. This test aides in preventing overuse of anti-biotics and is the only alternative to an actual blood lab work panel only taking 10 minutes real time saving time and money.

FebriDx® is indicated for use in patients aged 12-64 who present to urgent care or emergency care settings for evaluation of acute respiratory infection who have had symptoms for less than 7 days and within 3 days of fever onset.

• Identify a bacterial/viral infection and initiate appropriate treatment during a patient visit
• Improve practice workflow by identifying which patients require attention and who to prioritize for confirmatory testing
• Help reduce spread of infection by rapidly isolating potentially contagious patients
• Easily implement an outpatient antimicrobial stewardship solution

The FebriDx® Bacterial/Non-Bacterial Point-of-Care Assay is a qualitative visually read rapid immunoassay for the detection of human host response proteins, Myxovirus resistance protein A (MxA) and C-reactive protein (CRP) directly from fingerstick blood.

Key product features

• 98% negative predictive value to rule out bacterial infections
• Instrument-free
• Results in 10 minutes from a fingerstick
• FDA cleared, easy-to-use procedure

Potential CPT CODE DEFINITIONS

• 86332 Immune complex assay, Immune complex measurement
• 86140 Measurement C-reactive protein for detection of infection or inflammation

Resources

FebriDX Product Outline

PM-116.0-FebriDx-UrgentCare-US

SDS-00013.2 USA FebriDx Test

PM-127.1 FebriDx IFU-US