POC Test Identifies and Differentiates Viral from Bacterial Acute Respiratory Infection in 10 Minutes

Clinical diagnosis of patients with viral and bacterial acute respiratory infection can be a challenge due to similar signs and symptoms. An acute respiratory infection, typically presenting as cough, cold, sore throat, and runny nose, is the most common single reason for visiting a doctor and antibiotic prescriptions. However, most coughs, colds, sore throats, runny noses and earaches are caused by viruses and do not require antibiotics. Accurate detection of a viral infection can help prioritize which patients should have pathogen-specific testing performed. Now, a rapid test to differentiate a viral from a bacterial infection may lead to a considerable reduction in unnecessary antibiotics, which could lead to a reduction in antimicrobial resistance and adverse events.

FebriDx from Lumos Diagnostics (Melbourne, Australia) is a rapid, all-in-one point-of-care test device that can differentiate a viral from bacterial acute respiratory infection. FebriDx can be used to help in decision making at the point of care to reduce uncertainty, avoid unnecessary antibiotics, and enable appropriate patient management. It can assist with a diagnosis in 10 minutes for patients with acute respiratory infections. The FebriDx test is easily performed by a nurse or healthcare worker to help with decision making and freeing up valuable physician time. FebriDx can aid in determining whether a patient needs antibiotics within a single clinic visit.

In multi-center U.S. clinical trials to evaluate the diagnostic accuracy of FebriDx in distinguishing between bacterial and viral acute respiratory infections, the test was determined to have both high sensitivity (up to 95%) to detect a bacterial infection and up to 99% negative predictive value (NPV) to safely rule out a bacterial infection. Additionally, an economic evaluation has concluded that using the FebriDx test to guide antibiotic treatment for patients presenting with acute respiratory infections could potentially result in USD 2.5 billion of annual cost saving for the U.S. healthcare system.

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