Validation of SeptiCyte RAPID to Discriminate Sepsis from Non-Infectious Systemic Inflammation.

Autor: Balk R; Rush Medical College and Rush University Medical Center, Chicago, IL 60612, USA., Esper AM; Grady Memorial Hospital and Emory University School of Medicine, Atlanta, GA 30322, USA., Martin GS; Grady Memorial Hospital and Emory University School of Medicine, Atlanta, GA 30322, USA., Miller RR 3rd; FirstHealth of the Carolinas, Pinehurst, NC 28374, USA., Lopansri BK; Intermountain Medical Center, Murray, UT 84107, USA.; School of Medicine, University of Utah, Salt Lake City, UT 84132, USA., Burke JP; Intermountain Medical Center, Murray, UT 84107, USA.; School of Medicine, University of Utah, Salt Lake City, UT 84132, USA., Levy M; Warren Alpert Medical School, Brown University, Providence, RI 02912, USA., Opal S; Warren Alpert Medical School, Brown University, Providence, RI 02912, USA., Rothman RE; School of Medicine, Johns Hopkins University, Baltimore, MD 21205, USA., D'Alessio FR; School of Medicine, Johns Hopkins University, Baltimore, MD 21205, USA., Sidhaye VK; School of Medicine, Johns Hopkins University, Baltimore, MD 21205, USA., Aggarwal NR; Anschutz Medical Campus, University of Colorado, Denver, CO 80045, USA., Greenberg JA; Rush Medical College and Rush University Medical Center, Chicago, IL 60612, USA., Yoder M; Rush Medical College and Rush University Medical Center, Chicago, IL 60612, USA., Patel G; Rush Medical College and Rush University Medical Center, Chicago, IL 60612, USA., Gilbert E; Loyola University Medical Center, Maywood, IL 60153, USA., Parada JP; Loyola University Medical Center, Maywood, IL 60153, USA., Afshar M; School of Medicine and Public Health, University of Wisconsin, Madison, WI 53705, USA., Kempker JA; Grady Memorial Hospital and Emory University School of Medicine, Atlanta, GA 30322, USA., van der Poll T; Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands., Schultz MJ; Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands., Scicluna BP; Centre for Molecular Medicine and Biobanking, University of Malta, Msida MSD 2080, Malta.; Department of Applied Biomedical Science, Faculty of Health Sciences, Mater Dei Hospital, University of Malta, Msida MSD 2080, Malta., Klein Klouwenberg PMC; Fundashon Mariadal, Kralendijk, Bonaire, Netherlands Antilles., Liebler J; Keck Hospital of University of Southern California (USC), Los Angeles, CA 90033, USA.; Los Angeles General Medical Center, Los Angeles, CA 90033, USA., Blodget E; Keck Hospital of University of Southern California (USC), Los Angeles, CA 90033, USA.; Los Angeles General Medical Center, Los Angeles, CA 90033, USA., Kumar S; Keck Hospital of University of Southern California (USC), Los Angeles, CA 90033, USA.; Los Angeles General Medical Center, Los Angeles, CA 90033, USA., Navalkar K; Immunexpress Inc., Seattle, DC 98109, USA., Yager TD; Immunexpress Inc., Seattle, DC 98109, USA., Sampson D; Immunexpress Inc., Seattle, DC 98109, USA., Kirk JT; Immunexpress Inc., Seattle, DC 98109, USA., Cermelli S; Immunexpress Inc., Seattle, DC 98109, USA., Davis RF; Immunexpress Inc., Seattle, DC 98109, USA., Brandon RB; Immunexpress Inc., Seattle, DC 98109, USA.
Jazyk: angličtina
Zdroj: Journal of clinical medicine [J Clin Med] 2024 Feb 20; Vol. 13 (5). Date of Electronic Publication: 2024 Feb 20.
DOI: 10.3390/jcm13051194
Abstrakt: (1) Background: SeptiCyte RAPID is a molecular test for discriminating sepsis from non-infectious systemic inflammation, and for estimating sepsis probabilities. The objective of this study was the clinical validation of SeptiCyte RAPID, based on testing retrospectively banked and prospectively collected patient samples. (2) Methods: The cartridge-based SeptiCyte RAPID test accepts a PAXgene blood RNA sample and provides sample-to-answer processing in ~1 h. The test output (SeptiScore, range 0-15) falls into four interpretation bands, with higher scores indicating higher probabilities of sepsis. Retrospective (N = 356) and prospective (N = 63) samples were tested from adult patients in ICU who either had the systemic inflammatory response syndrome (SIRS), or were suspected of having/diagnosed with sepsis. Patients were clinically evaluated by a panel of three expert physicians blinded to the SeptiCyte test results. Results were interpreted under either the Sepsis-2 or Sepsis-3 framework. (3) Results: Under the Sepsis-2 framework, SeptiCyte RAPID performance for the combined retrospective and prospective cohorts had Areas Under the ROC Curve (AUCs) ranging from 0.82 to 0.85, a negative predictive value of 0.91 (sensitivity 0.94) for SeptiScore Band 1 (score range 0.1-5.0; lowest risk of sepsis), and a positive predictive value of 0.81 (specificity 0.90) for SeptiScore Band 4 (score range 7.4-15; highest risk of sepsis). Performance estimates for the prospective cohort ranged from AUC 0.86-0.95. For physician-adjudicated sepsis cases that were blood culture (+) or blood, urine culture (+)(+), 43/48 (90%) of SeptiCyte scores fell in Bands 3 or 4. In multivariable analysis with up to 14 additional clinical variables, SeptiScore was the most important variable for sepsis diagnosis. A comparable performance was obtained for the majority of patients reanalyzed under the Sepsis-3 definition, although a subgroup of 16 patients was identified that was called septic under Sepsis-2 but not under Sepsis-3. (4) Conclusions: This study validates SeptiCyte RAPID for estimating sepsis probability, under both the Sepsis-2 and Sepsis-3 frameworks, for hospitalized patients on their first day of ICU admission.
Databáze: MEDLINE
Nepřihlášeným uživatelům se plný text nezobrazuje