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

Abstract 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)...

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Main Authors: Richard G. Bachur, Sheldon L. Kaplan, Cesar A. Arias, Natasha Ballard, Karen C. Carroll, Andrea T. Cruz, Richard Gordon Jr., Salim Halabi, Jeffrey D. Harris, Kristina G. Hulten, Theresa Jacob, Mark D. Kellogg, Adi Klein, Pninit Shaked Mishan, Sergey M. Motov, Octavia M. Peck‐Palmer, Leticia M. Ryan, Ma'anit Shapira, George S. Suits, Henry E. Wang, Alexandra Weissman, Richard E. Rothman
Format: Article
Language:English
Published: Elsevier 2024-06-01
Series:Journal of the American College of Emergency Physicians Open
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Online Access:https://doi.org/10.1002/emp2.13167
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author Richard G. Bachur
Sheldon L. Kaplan
Cesar A. Arias
Natasha Ballard
Karen C. Carroll
Andrea T. Cruz
Richard Gordon Jr.
Salim Halabi
Jeffrey D. Harris
Kristina G. Hulten
Theresa Jacob
Mark D. Kellogg
Adi Klein
Pninit Shaked Mishan
Sergey M. Motov
Octavia M. Peck‐Palmer
Leticia M. Ryan
Ma'anit Shapira
George S. Suits
Henry E. Wang
Alexandra Weissman
Richard E. Rothman
author_facet Richard G. Bachur
Sheldon L. Kaplan
Cesar A. Arias
Natasha Ballard
Karen C. Carroll
Andrea T. Cruz
Richard Gordon Jr.
Salim Halabi
Jeffrey D. Harris
Kristina G. Hulten
Theresa Jacob
Mark D. Kellogg
Adi Klein
Pninit Shaked Mishan
Sergey M. Motov
Octavia M. Peck‐Palmer
Leticia M. Ryan
Ma'anit Shapira
George S. Suits
Henry E. Wang
Alexandra Weissman
Richard E. Rothman
author_sort Richard G. Bachur
collection DOAJ
description Abstract 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 cases yielded equivocal MMBV scores. Area under the curve for MMBV was 0.95 (0.90–0.99). Conclusions MMBV 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.
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spelling doaj-art-e7fc5ef3cf90420587dd3af3e93259a52025-08-20T03:03:42ZengElsevierJournal of the American College of Emergency Physicians Open2688-11522024-06-0153n/an/a10.1002/emp2.13167A rapid host–protein test for differentiating bacterial from viral infection: Apollo diagnostic accuracy studyRichard G. Bachur0Sheldon L. Kaplan1Cesar A. Arias2Natasha Ballard3Karen C. Carroll4Andrea T. Cruz5Richard Gordon Jr.6Salim Halabi7Jeffrey D. Harris8Kristina G. Hulten9Theresa Jacob10Mark D. Kellogg11Adi Klein12Pninit Shaked Mishan13Sergey M. Motov14Octavia M. Peck‐Palmer15Leticia M. Ryan16Ma'anit Shapira17George S. Suits18Henry E. Wang19Alexandra Weissman20Richard E. Rothman21Division of Emergency Medicine Boston Children's Hospital Boston Massachusetts USADivision of Infectious Disease Texas Children's Hospital Houston Texas USADivision of Infectious Diseases Department of Medicine Houston Methodist Hospital Houston Texas USAAmerican Family Care Urgent Care Chattanooga Tennessee USADivision of Infectious Diseases The Johns Hopkins University Baltimore Maryland USADivision of Infectious Disease Texas Children's Hospital Houston Texas USADepartment of Emergency Medicine University of Texas Health Science Center at Houston (UTHealth) Houston Texas USADepartment of Emergency Medicine Carmel Medical Center Haifa IsraelAmerican Family Care Urgent Care Powdersville South Carolina USADivision of Infectious Disease Texas Children's Hospital Houston Texas USAClinical Trials Unit & Translational Research Maimonides Medical Center Brooklyn New York USADepartment of Pathology Boston Children's Hospital Boston Massachusetts USADepartment of Pediatrics Hillel Yaffe Medical Center Hadera IsraelDepartment of Emergency Medicine Carmel Medical Center Haifa IsraelDepartment of Emergency Medicine Maimonides Medical Center Brooklyn New York USADivision of Clinical Chemistry University of Pittsburgh Medical Center Pittsburgh Pennsylvania USAPediatrics Emergency Medicine Johns Hopkins University Baltimore Maryland USARappaport Faculty of Medicine Technion Institute of Technology Haifa IsraelAmerican Family Care Urgent Care Easley South Carolina USADepartment of Emergency Medicine University of Texas Health Science Center at Houston (UTHealth) Houston Texas USADepartment of Emergency Medicine University of Pittsburgh Medical Center Pittsburgh Pennsylvania USADepartment of Emergency Medicine The Johns Hopkins University Baltimore Maryland USAAbstract 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 cases yielded equivocal MMBV scores. Area under the curve for MMBV was 0.95 (0.90–0.99). Conclusions MMBV 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.https://doi.org/10.1002/emp2.13167bacterial infectionCRPdiagnostic testhost–responseIP‐10TRAIL
spellingShingle Richard G. Bachur
Sheldon L. Kaplan
Cesar A. Arias
Natasha Ballard
Karen C. Carroll
Andrea T. Cruz
Richard Gordon Jr.
Salim Halabi
Jeffrey D. Harris
Kristina G. Hulten
Theresa Jacob
Mark D. Kellogg
Adi Klein
Pninit Shaked Mishan
Sergey M. Motov
Octavia M. Peck‐Palmer
Leticia M. Ryan
Ma'anit Shapira
George S. Suits
Henry E. Wang
Alexandra Weissman
Richard E. Rothman
A rapid host–protein test for differentiating bacterial from viral infection: Apollo diagnostic accuracy study
Journal of the American College of Emergency Physicians Open
bacterial infection
CRP
diagnostic test
host–response
IP‐10
TRAIL
title A rapid host–protein test for differentiating bacterial from viral infection: Apollo diagnostic accuracy study
title_full A rapid host–protein test for differentiating bacterial from viral infection: Apollo diagnostic accuracy study
title_fullStr A rapid host–protein test for differentiating bacterial from viral infection: Apollo diagnostic accuracy study
title_full_unstemmed A rapid host–protein test for differentiating bacterial from viral infection: Apollo diagnostic accuracy study
title_short A rapid host–protein test for differentiating bacterial from viral infection: Apollo diagnostic accuracy study
title_sort rapid host protein test for differentiating bacterial from viral infection apollo diagnostic accuracy study
topic bacterial infection
CRP
diagnostic test
host–response
IP‐10
TRAIL
url https://doi.org/10.1002/emp2.13167
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