A rapid host–protein test for differentiating bacterial from viral infection: Apollo diagnostic accuracy study

作者：Richard G. Bachur, Sheldon L. Kaplan, César A. Arias, Natasha Ballard, Karen C. Carroll, Andrea T. Cruz, Richard Gordon, Salim Halabi, Jeffrey D. Harris, Kristina G. Hultén, Theresa Jacob, Mark D. Kellogg, Adi Klein, Pninit Shaked Mishan, Sergey Motov, Octavia M. Peck‐Palmer, Leticia Manning Ryan, Maanit Shapira, George S. Suits, Henry E. Wang, Alexandra Weissman, Richard E. Rothman · 发表于：Journal of the American College of Emergency Physicians Open · 年份：2024 · DOI：10.1002/emp2.13167 · 被引用次数：27 · 研究领域：Immune Response and Inflammation、Sepsis Diagnosis and Treatment、Neonatal and Maternal Infections

Objectives: To determine the diagnostic accuracy of a rapid host-protein test for differentiating bacterial from viral infections in patients who presented to the emergency department (ED) or urgent care center (UCC). Methods: This was a prospective multicenter, blinded study. MeMed BV (MMBV), a test based on tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), interferon gamma-inducible protein-10 (IP-10), and C-reactive protein (CRP), was measured using a rapid measurement platform. Patients were enrolled from 9 EDs and 3 UCCs in the United States and Israel. Patients >3 months of age presenting with fever and clinical suspicion of acute infection were considered eligible. MMBV results were not provided to the treating clinician. MMBV results (bacterial/viral/equivocal) were compared against a reference standard method for classification of infection etiology determined by expert panel adjudication. Experts were blinded to MMBV results. They were provided with comprehensive patient data, including laboratory, microbiological, radiological and follow-up. Results: Of 563 adults and children enrolled, 476 comprised the study population (314 adults, 162 children). The predominant clinical syndrome was respiratory tract infection (60.5% upper, 11.3% lower). MMBV demonstrated sensitivity of 90.0% (95% confidence interval [CI]: 80.3-99.7), specificity of 92.8% (90.0%-95.5%), and negative predictive value of 98.8% (96.8%-99.6%) for bacterial infections. Only 7.2% of cas...