FebriDx Prospective Multicenter Clinical Trial Published in the Journal of Clinical Medicine

October 9, 2017

A prospective, multicenter, cross-sectional study was published on October 7, 2017 in the Journal of Clinical Medicine in an article entitled, “Diagnostic Accuracy of FebriDx: A Rapid Test to Detect Immune Responses to Viral and Bacterial Upper Respiratory Infections.” This clinical trial enrolled adults and children with upper respiratory infections (URIs) to evaluate the diagnostic accuracy of the FebriDx test to identify clinically significant bacterial infections with host response and acute pathogenic viral infection in patients who presented with a history of fever in the outpatient setting.

This study enrolled 370 patients, 205 symptomatic patients with URI and 165 asymptomatic patients from 10 clinical sites in the U.S. For bacterial detection, agreement between FebriDx and the reference standard was 92%, with FebriDx having a sensitivity of 80% and specificity of 93%. Bacterial sensitivity increased further in patients that had a confirmed fever at the time of enrollment. Most importantly, FebriDx demonstrated a negative predictive value (NPV) of 97% for bacterial infection. For viral detection, agreement was 84%, sensitivity ranged between 86-87%, specificity was 83-88%, and the NPV was 93-95% depending on the comparator method. Additionally, 38% of viral infections generated elevated CRP and would lead to antibiotic overtreatment if the CRP result was used independently of MxA.

 

 

To learn more about FebriDx*, click here.

* The FebriDx test is commercially available in Canada, Europe, Saudi Arabia, and the Gulf Cooperative Countries, and Singapore. FebriDx is not FDA cleared and is not commercially available in the U.S.

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