Rapid and Robust Identification of Sepsis Using SeptiCyte RAPID in a Heterogeneous Patient Population

<b>Background/Objective:</b> SeptiCyte RAPID is a transcriptional host response assay that discriminates between sepsis and non-infectious systemic inflammation (SIRS) with a one-hour turnaround time. The overall performance of this test in a cohort of 419 patients has recently been described [Balk et al., J Clin Med 2024, 13, 1194]. In this study, we present the results from a detailed stratification analysis in which SeptiCyte RAPID performance was evaluated in the same cohort across patient groups and subgroups encompassing different demographics, comorbidities and disease, sources and types of pathogens, interventional treatments, and clinically defined phenotypes. The aims were to identify variables that might affect the ability of SeptiCyte RAPID to discriminate between sepsis and SIRS and to determine if any patient subgroups appeared to present a diagnostic challenge for the test. <b>Methods:</b> (1) Subgroup analysis, with subgroups defined by individual demographic or clinical variables, using conventional statistical comparison tests. (2) Principal component analysis and k-means clustering analysis to investigate phenotypic subgroups defined by unique combinations of demographic and clinical variables. <b>Results:</b> No significant differences in SeptiCyte RAPID performance were observed between most groups and subgroups. One notable exception involved an enhanced SeptiCyte RAPID performance for a phenotypic subgroup defined by a combination of clinical variables suggesting a septic shock response. <b>Conclusions:</b> We conclude that for this patient cohort, SeptiCyte RAPID performance was largely unaffected by key variables associated with heterogeneity in patients suspected of sepsis.

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Publication Details

Journal
Journal of Clinical Medicine
Published
2024-10-10
DOI
https://doi.org/10.3390/jcm13206044
Citations
5
Primary Topic
Sepsis Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
1.93

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article

Rapid and Robust Identification of Sepsis Using SeptiCyte RAPID in a Heterogeneous Patient Population

Mitchell M. Levy, Venkataramana K. Sidhaye, Janice M. Liebler, Marcus Josephus Schultz et al.
5 citations
Journal of Clinical Medicine
Sepsis Diagnosis and Treatment
1.93
article

Rapid and Robust Identification of Sepsis Using SeptiCyte RAPID in a Heterogeneous Patient Population

Mitchell M. Levy, Venkataramana K. Sidhaye, Janice M. Liebler, Marcus Josephus Schultz, Thomas D. Yager, Richard E. Rothman, Krupa Navalkar, Bert K. Lopansri, Silvia Cermelli, Neil R. Aggarwal, Greg S. Martin, Mark A. Yoder, Xue W. Mei, Annette M. Esper, Franco R. D’Alessio, Emily Blodget, Tom van der Poll, Roy F. Davis, Jared A. Greenberg, John P. Burke, James T. Kirk, Majid Afshar, Peter M. C. Klein Klouwenberg, Gourang Patel, R.A. Balk, Jordan A. Kempker, Brendon P. Scicluna, Richard B. Brandon, Santhi Kumar, Dayle Sampson, Russell R. Miller, Jorge P. Parada, Emily Gilbert
article en
5 citations

Abstract

<b>Background/Objective:</b> SeptiCyte RAPID is a transcriptional host response assay that discriminates between sepsis and non-infectious systemic inflammation (SIRS) with a one-hour turnaround time. The overall performance of this test in a cohort of 419 patients has recently been described [Balk et al., J Clin Med 2024, 13, 1194]. In this study, we present the results from a detailed stratification analysis in which SeptiCyte RAPID performance was evaluated in the same cohort across patient groups and subgroups encompassing different demographics, comorbidities and disease, sources and types of pathogens, interventional treatments, and clinically defined phenotypes. The aims were to identify variables that might affect the ability of SeptiCyte RAPID to discriminate between sepsis and SIRS and to determine if any patient subgroups appeared to present a diagnostic challenge for the test. <b>Methods:</b> (1) Subgroup analysis, with subgroups defined by individual demographic or clinical variables, using conventional statistical comparison tests. (2) Principal component analysis and k-means clustering analysis to investigate phenotypic subgroups defined by unique combinations of demographic and clinical variables. <b>Results:</b> No significant differences in SeptiCyte RAPID performance were observed between most groups and subgroups. One notable exception involved an enhanced SeptiCyte RAPID performance for a phenotypic subgroup defined by a combination of clinical variables suggesting a septic shock response. <b>Conclusions:</b> We conclude that for this patient cohort, SeptiCyte RAPID performance was largely unaffected by key variables associated with heterogeneity in patients suspected of sepsis.

Journal of Clinical MedicineVol. 13(20)
University of Southern California (US), Rush University Medical Center (US), Loyola University Medical Center (US), Grady Memorial Hospital (US), University of Wisconsin–Madison (US), Johns Hopkins University (US), University of Miami (US), Emory University (US), University of Malta (MT), University of Utah (US), Brown University (US), Johns Hopkins Medicine (US), Keck Hospital of USC (US), Mater Dei Hospital (MT), Intermountain Medical Center (US), University of Oxford (GB), Los Angeles Medical Center (US), Princeton BioMeditech (United States) (US), FirstHealth of the Carolinas (US), Amsterdam University Medical Centers (NL), University of Colorado Anschutz Medical Campus (US), Medical University of Vienna (AT), University of Amsterdam (NL), University of Colorado Denver (US)
University of Southern California, Rush University
Reduced inequalities
Openalex Percentile: Top 13%
Sepsis Diagnosis and Treatment
1.93
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