Comparison of three rapid diagnostic tests for bloodstream infections using Benefit-risk Evaluation Framework (BED-FRAME)

Authors

Richard D. Smith, Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Min Zhan, Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Shanshan Zhang, Biostatistics Center and the Department of Biostatistics and Bioinformatics, The George Washington University, Washington, D.C., USA.
Surbhi Leekha, Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Anthony Harris, Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Yohei Doi, Division of Infectious Diseases, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
Scott Evans, Biostatistics Center and the Department of Biostatistics and Bioinformatics, The George Washington University, Washington, D.C., USA.
J Kristie Johnson, Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Robert K. Ernst, Department of Microbial Pathogenesis, University of Maryland School of Dentistry, Baltimore, Maryland, USA.

Document Type

Journal Article

Publication Date

1-17-2024

Journal

Journal of clinical microbiology

Volume

62

Issue

1

DOI

10.1128/jcm.01096-23

Keywords

BED-FRAME; blood culture; bloodstream infections; rapid diagnostic testing

Abstract

Rapid diagnostic tests (RDTs) for bloodstream infections have the potential to reduce time to appropriate antimicrobial therapy and improve patient outcomes. Previously, an in-house, lipid-based, matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) method, Fast Lipid Analysis Technique (FLAT MS), has shown promise as a rapid pathogen identification method. In this study, FLAT MS for direct from blood culture identification was evaluated and compared to FDA-cleared identification methods using the Benefit-risk Evaluation Framework (BED-FRAME) analysis. FLAT MS was evaluated and compared to Bruker Sepsityper and bioMérieux BioFire FilmArray BCID2 using results from a previous study. For this study, 301 positive blood cultures were collected from the University of Maryland Medical Center. The RDTs were compared by their sensitivities, time-to-results, hands-on time, and BED-FRAME analysis. The overall sensitivity of all platforms compared to culture results from monomicrobial-positive blood cultures was 88.3%. However, the three RDTs differed in their accuracy for identifying Gram-positive bacteria, Gram-negative bacteria, and yeast. Time-to-results for FLAT MS, Sepsityper, and BioFire BCID2 were all approximately one hour. Hands-on times for FLAT MS, Sepsityper, and BioFire BCID2 were 10 (±1.3), 40 (±2.8), and 5 (±0.25) minutes, respectively. BED-FRAME demonstrated that each RDT had utility at different pathogen prevalence and relative importance. BED-FRAME is a useful tool that can used to determine which RDT is best for a healthcare center.

APA Citation

Smith, Richard D.; Zhan, Min; Zhang, Shanshan; Leekha, Surbhi; Harris, Anthony; Doi, Yohei; Evans, Scott; Kristie Johnson, J; and Ernst, Robert K., "Comparison of three rapid diagnostic tests for bloodstream infections using Benefit-risk Evaluation Framework (BED-FRAME)" (2024). GW Authored Works. Paper 4169.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/4169

Department

Biostatistics and Bioinformatics