Lumos Diagnostics announced that results of its DISRUPT clinical trial of FebriDx® as an aid to differentiate bacterial from viral acute respiratory infections (ARI's) has been published in the peer-reviewed journal JAMA Open Network. The authors concluded that the rapid diagnostic test demonstrated performance that may inform clinicians when assessing for bacterial or viral etiology of ARI symptoms. The DISRUPT trial was a prospective, blinded, multicentre, observational study of FebriDx's performance in identifying bacterial versus viral acute respiratory infections. Participants were enrolled between October 2019 and April 2021 at 20 outpatient sites throughout the United States.

The trial included 496 ARI patients with a clinically adjudicated final diagnosis, and 170 subjects without an ARI. Participants with ARIs were diagnostically tested with FebriDx as well as multiplex-PCR (polymerase chain reaction) testing and culture algorithm designed to identify 28 different pathogens. The results of this trial have been published in the peer-reviewed journal JAMA Open Network as an Original Investigation entitled Diagnostic accuracy of a bacterial and viral biomarker Point-of-Care test in the outpatient setting (doi:10.1001/jamanetworkopen.2022.34588).

In this study FebriDx demonstrated sensitivity of 93.2% and specificity of 88.4% for bacterial infections, providing a negative predictive value (NPV) of 98.7%. For viral ARIs, FebriDx demonstrated sensitivity of 70.3%, specificity of 88.0% and an NPV of 66.7%.