Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 May 8;5(3):e13167.
doi: 10.1002/emp2.13167. eCollection 2024 Jun.

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

Richard G Bachur  1 , Sheldon L Kaplan  2 , Cesar A Arias  3   4   5 , Natasha Ballard  6 , Karen C Carroll  7 , Andrea T Cruz  2   8 , Richard Gordon Jr  9 , Salim Halabi  10 , Jeffrey D Harris  11 , Kristina G Hulten  2 , Theresa Jacob  12 , Mark D Kellogg  13 , Adi Klein  14   15 , Pninit Shaked Mishan  10 , Sergey M Motov  16 , Octavia M Peck-Palmer  17 , Leticia M Ryan  18 , Ma'anit Shapira  15   19 , George S Suits  20 , Henry E Wang  9 , Alexandra Weissman  21 , Richard E Rothman  22
Affiliations

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

Richard G Bachur et al. J Am Coll Emerg Physicians Open. .

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.

Keywords: CRP; IP‐10; TRAIL; bacterial infection; diagnostic test; host–response.

PubMed Disclaimer

Conflict of interest statement

Cesar A. Arias, Natasha Ballard, Karen C. Carroll, Andrea T. Cruz, Richard Gordon, 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, and Richard E. Rothman have no relevant conflict of interests to declare. Richard G. Bachur and Sheldon L. Kaplan participated in a scientific advisory board on health economic modeling for MeMed and were compensated for their time. Richard E. Rothman participated in a scientific board on health care economic modeling (without compensation). Richard G. Bachur, Sheldon L. Kaplan, and Richard E. Rothman participated in discussions with the U.S. Food and Drug Administration clearance and were involved in study design, patient recruitment, data collection and analysis, and drafting and revising the manuscript.

Figures

FIGURE 1
FIGURE 1
MeMed BV (MMBV) interpretation.
FIGURE 2
FIGURE 2
Patient enrollment flow: Note that “viral” includes non‐infectious cases and “bacterial” includes bacterial and viral co‐infections. MMBV, MeMed BV.
FIGURE 3
FIGURE 3
MeMed BV (MMBV) distribution according to reference standard. Each dot represents a patient in the study population (n = 476). Red line corresponds to group median and red dot corresponds to group average.
FIGURE 4
FIGURE 4
Performance of MeMed BV (MMBV) versus procalcitonin (PCT) in differentiating between bacterial and viral infection, n = 416. MMBV outperformed PCT (p < 0.0001). AUC, area under the receiver operating characteristic curve; CI, confidence interval.
See this image and copyright information in PMC

References

    1. Hasegawa K, Tsugawa Y, Cohen A, et al. Infectious disease‐related emergency department visits among children in the US. Pediatr Infect Dis J. 2015;34(7):681‐685. - PMC - PubMed
    1. Goto T, Yoshida K, Tsugawa Y, et al. Infectious disease‐related emergency department visits of elderly adults in the United States, 2011–2012. J Am Geriatr Soc. 2016;64(1):31‐36. - PubMed
    1. Stenehjem E, Wallin A, Fleming‐Dutra KE, et al. Antibiotic prescribing variability in a large urgent care network: a new target for outpatient stewardship. Clin Infect Dis. 2020;70(8):1781‐1787. - PMC - PubMed
    1. Klein EY, Martinez EM, May L, et al. Categorical risk perception drives variability in antibiotic prescribing in the emergency department: a mixed methods observational study. J Gen Intern Med. 2017;32(10):1083‐1089. - PMC - PubMed
    1. Denny KJ, Gartside JG, Alcorn K, et al. Appropriateness of antibiotic prescribing in the emergency department. J Antimicrob Chemother. 2019;74(2):515‐520. - PMC - PubMed