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

Author:

Bachur Richard G.1,Kaplan Sheldon L.2,Arias Cesar A.345,Ballard Natasha6,Carroll Karen C.7,Cruz Andrea T.28,Gordon Richard9,Halabi Salim10,Harris Jeffrey D.11,Hulten Kristina G.2,Jacob Theresa12,Kellogg Mark D.13,Klein Adi1415,Mishan Pninit Shaked10,Motov Sergey M.16,Peck‐Palmer Octavia M.17,Ryan Leticia M.18,Shapira Ma'anit1519,Suits George S.20,Wang Henry E.9,Weissman Alexandra21,Rothman Richard E.22

Affiliation:

1. Division of Emergency Medicine Boston Children's Hospital Boston Massachusetts USA

2. Division of Infectious Disease Texas Children's Hospital Houston Texas USA

3. Division of Infectious Diseases Department of Medicine Houston Methodist Hospital Houston Texas USA

4. Center for Infectious Diseases Houston Methodist Research Institute Houston Texas USA

5. Department of Medicine Weill Cornell New York New York USA

6. American Family Care Urgent Care Chattanooga Tennessee USA

7. Division of Infectious Diseases The Johns Hopkins University Baltimore Maryland USA

8. Emergency Center Texas Children's Hospital Houston Texas USA

9. Department of Emergency Medicine University of Texas Health Science Center at Houston (UTHealth) Houston Texas USA

10. Department of Emergency Medicine Carmel Medical Center Haifa Israel

11. American Family Care Urgent Care Powdersville South Carolina USA

12. Clinical Trials Unit & Translational Research Maimonides Medical Center Brooklyn New York USA

13. Department of Pathology Boston Children's Hospital Boston Massachusetts USA

14. Department of Pediatrics Hillel Yaffe Medical Center Hadera Israel

15. Rappaport Faculty of Medicine Technion Institute of Technology Haifa Israel

16. Department of Emergency Medicine Maimonides Medical Center Brooklyn New York USA

17. Division of Clinical Chemistry University of Pittsburgh Medical Center Pittsburgh Pennsylvania USA

18. Pediatrics Emergency Medicine Johns Hopkins University Baltimore Maryland USA

19. Clinical Laboratory Division Hillel Yaffe Medical Center Hadera Israel

20. American Family Care Urgent Care Easley South Carolina USA

21. Department of Emergency Medicine University of Pittsburgh Medical Center Pittsburgh Pennsylvania USA

22. Department of Emergency Medicine The Johns Hopkins University Baltimore Maryland USA

Abstract

AbstractObjectivesTo 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).MethodsThis 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.ResultsOf 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 cases yielded equivocal MMBV scores. Area under the curve for MMBV was 0.95 (0.90–0.99).ConclusionsMMBV had a high sensitivity and specificity relative to reference standard for differentiating bacterial from viral infections. Future implementation of MMBV for patients with suspected acute infections could potentially aid with appropriate antibiotic decision‐making.

Publisher

Wiley

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