Validation of a Novel, Rapid Sepsis Diagnostic for Emergency Department Use.

Autor:	O'Neal HR Jr; Pulmonary and Critical Care, Louisiana State University Health Sciences Center, Baton Rouge, LA.; Pulmonary & Critical Care, Our Lady of the Lake Regional Medical Center, Baton Rouge, LA., Sheybani R; Cytovale, Inc, San Francisco, CA., Janz DR; Pulmonary & Critical Care, University Medical Center, New Orleans, LA., Scoggins R; Pulmonary and Critical Care, Kootenai Health, Coeur d'Alene, ID., Jagneaux T; Pulmonary and Critical Care, Louisiana State University Health Sciences Center, Baton Rouge, LA.; Pulmonary & Critical Care, Our Lady of the Lake Regional Medical Center, Baton Rouge, LA., Walker JE; Pulmonary and Critical Care, Louisiana State University Health Sciences Center, Baton Rouge, LA.; Pulmonary & Critical Care, Our Lady of the Lake Regional Medical Center, Baton Rouge, LA., Henning DJ; Department of Emergency Medicine, University of Washington, Seattle, WA., Rosenman E; Department of Emergency Medicine, University of Washington, Seattle, WA., Mahler SA; Departments of Emergency Medicine, Epidemiology and Prevention, and Implementation Science, Wake Forest University School of Medicine, Winston-Salem, NC., Regunath H; Critical Care Medicine and Infectious Diseases, University of Maryland-Baltimore Washington Medical Center, Glen Burnie, MD.; Division of Infectious Diseases, Department of Medicine, University of Missouri School of Medicine, Columbia, MO., Sampson CS; Department of Emergency Medicine, University of Missouri School of Medicine, Columbia, MO., Files DC; Pulmonary and Critical Care Medicine, Wake Forest University School of Medicine, Winston Salem, NC., Fremont RD; Department of Medicine, Meharry School of Medicine, Nashville, TN., Noto MJ; Allergy, Pulmonary, and Critical Care Medicine, Emory University School of Medicine, Atlanta, GA., Schneider EE; Pulmonary and Critical Care, Bon Secours Mercy Health System, Richmond, VA., Shealey WR; Department of Medicine, Infectious Disease, Creighton University School of Medicine, Phoenix, AZ., Berlinger MS; Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD., Carver TC; Division of Trauma, Critical Care, and Acute Care Surgery, Medical College of Wisconsin, Milwaukee, WI., Walker MK; Critical Care Medicine, National Institutes of Health, Bethesda, MD., Ledeboer NA; Department of Pathology, Medical College of Wisconsin, Milwaukee, WI., Shah AM; Cytovale, Inc, San Francisco, CA., Tse HTK; Pulmonary & Critical Care, Our Lady of the Lake Regional Medical Center, Baton Rouge, LA., DiCarlo D; Department of Bioengineering and Biomedical Engineering, University of California, Los Angeles, CA., Rice TW; Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN., Thomas CB; Pulmonary and Critical Care, Louisiana State University Health Sciences Center, Baton Rouge, LA.; Pulmonary & Critical Care, Our Lady of the Lake Regional Medical Center, Baton Rouge, LA.
Jazyk:	angličtina
Zdroj:	Critical care explorations [Crit Care Explor] 2024 Feb 07; Vol. 6 (2), pp. e1026. Date of Electronic Publication: 2024 Feb 07 (Print Publication: 2024).
DOI:	10.1097/CCE.0000000000001026
Abstrakt:	Objectives: To assess the in vitro IntelliSep test, a microfluidic assay that quantifies the state of immune activation by evaluating the biophysical properties of leukocytes, as a rapid diagnostic for sepsis. Design: Prospective cohort study. Setting: Five emergency departments (EDs) in Louisiana, Missouri, North Carolina, and Washington. Patients: Adult patients presenting to the ED with signs (two of four Systemic Inflammatory Response Syndrome criteria, where one must be temperature or WBC count) or suspicion (provider-ordered culture) of infection. Interventions: All patients underwent testing with the IntelliSep using ethylene diamine tetraacetic acid-anticoagulated whole blood followed by retrospective adjudication for sepsis by sepsis-3 criteria by a blinded panel of physicians. Measurements and Main Results: Of 599 patients enrolled, 572 patients were included in the final analysis. The result of the IntelliSep test is reported as the IntelliSep Index (ISI), ranging from 0.1 to 10.0, divided into three interpretation bands for the risk of sepsis: band 1 (low) to band 3 (high). The median turnaround time for ISI results was 7.2 minutes. The ISI resulted band 1 in 252 (44.1%), band 2 in 160 (28.0%), and band 3 in 160 (28.0%). Sepsis occurred in 26.6% (152 of 572 patients). Sepsis prevalence was 11.1% (95% CI, 7.5-15.7%) in band 1, 28.1% (95% CI, 21.3-35.8%) in band 2, and 49.4% (95% CI, 41.4-57.4%) in band 3. The Positive Percent Agreement of band 1 was 81.6% and the Negative Percent Agreement of band 3 was 80.7%, with an area under the receiver operating characteristic curve of 0.74. Compared with band 1, band 3 correlated with adverse clinical outcomes, including mortality, and resource utilization. Conclusions: Increasing ISI interpretation band is associated with increasing probability of sepsis in patients presenting to the ED with suspected infection. (Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine.)
Databáze:	MEDLINE
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