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Diagnostic Accuracy of FebriDx: A Rapid Test to Detect Immune Responses to Viral and Bacterial Upper Respiratory Infections

Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN 37232, USA
Clinical Research of South Florida, Coral Gables, FL 33134, USA
Clinical Research Associates, Inc., Nashville, TN 37203, USA
Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA 02114, USA
Department of Emergency Medicine, Brigham and Women’s Hospital, Boston, MA 02115, USA
Department of Emergency Medicine, New York Methodist Hospital, Brooklyn, NY 11215, USA
Department of Emergency Medicine, University of Alabama School of Medicine, Birmingham, AL 35233, USA
Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA
Author to whom correspondence should be addressed.
Academic Editor: Emmanuel Andrès
J. Clin. Med. 2017, 6(10), 94;
Received: 14 August 2017 / Revised: 21 September 2017 / Accepted: 21 September 2017 / Published: 7 October 2017
C-reactive protein (CRP) and myxovirus resistance protein A (MxA) are associated with bacterial and viral infections, respectively. We conducted a prospective, multicenter, cross-sectional study of adults and children with febrile upper respiratory tract infections (URIs) to evaluate the diagnostic accuracy of a rapid CRP/MxA immunoassay to identify clinically significant bacterial infection with host response and acute pathogenic viral infection. The reference standard for classifying URI etiology was an algorithm that included throat bacterial culture, upper respiratory PCR for viral and atypical pathogens, procalcitonin, white blood cell count, and bandemia. The algorithm also allowed for physician override. Among 205 patients, 25 (12.2%) were classified as bacterial, 53 (25.9%) as viral, and 127 (62.0%) negative by the reference standard. For bacterial detection, agreement between FebriDx and the reference standard was 91.7%, with FebriDx having a sensitivity of 80% (95% CI: 59–93%), specificity of 93% (89–97%), positive predictive value (PPV) of 63% (45–79%), and a negative predictive value (NPV) of 97% (94–99%). For viral detection, agreement was 84%, with a sensitivity of 87% (75–95%), specificity of 83% (76–89%), PPV of 64% (63–75%), and NPV of 95% (90–98%). FebriDx may help to identify clinically significant immune responses associated with bacterial and viral URIs that are more likely to require clinical management or therapeutic intervention, and has potential to assist with antibiotic stewardship. View Full-Text
Keywords: respiratory infection; antibiotic stewardship; MxA; CRP; immunoassay; FebriDx respiratory infection; antibiotic stewardship; MxA; CRP; immunoassay; FebriDx
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Self, W.H.; Rosen, J.; Sharp, S.C.; Filbin, M.R.; Hou, P.C.; Parekh, A.D.; Kurz, M.C.; Shapiro, N.I. Diagnostic Accuracy of FebriDx: A Rapid Test to Detect Immune Responses to Viral and Bacterial Upper Respiratory Infections. J. Clin. Med. 2017, 6, 94.

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