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Updated: Aug 8, 2026
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A Data-Driven Approach to Quantifying Immune States in Sepsis
Published on: February 7, 2025
Validation of SeptiCyte RAPID to Discriminate Sepsis From Noninfectious Systemic Inflammation in Critically Ill
Jerry J Zimmerman1, Sainath Raman2, Warwick W Butt3
1Department of Pediatrics GAPPSS, GEODESIC Investigator (J.J.Z.) and RPD panelist (E.Y.K.), Seattle Children's Hospital, University of Washington School of Medicine, Seattle, WA.
Summary
The SeptiCyte RAPID test accurately identifies sepsis probability in critically ill children, showing performance similar to adults. Further studies are needed to confirm its real-world clinical utility and impact.
Area of Science:
- Pediatric critical care medicine
- Infectious disease diagnostics
- Biomarker research
Background:
- Accurate sepsis diagnosis in children is challenging, with a need for precise biomarkers.
- The SeptiCyte RAPID is a point-of-care host gene expression test for sepsis probability.
- Previous studies reported SeptiCyte RAPID performance in adults.
Purpose of the Study:
- To clinically validate the SeptiCyte RAPID test as a sepsis diagnostic adjunct in critically ill children.
- To evaluate the performance of SeptiCyte RAPID in differentiating sepsis from noninfectious systemic inflammatory response syndrome (SIRS) in pediatric patients.
Main Methods:
- A retrospective, noninterventional study enrolled 284 critically ill children (1 month to 18 years) across multiple sites.
- Patients met criteria for SIRS; sepsis vs. noninfectious SIRS was determined by physician adjudication (Retrospective Physician Diagnosis [RPD]).
- Diagnostic performance was assessed using area under the curve (AUC), likelihood ratios, and correlation between SeptiScore and sepsis probability.
Main Results:
- SeptiCyte RAPID demonstrated strong diagnostic performance for sepsis in children, with AUCs ranging from 0.80 to 0.83.
- Integrating clinical parameters (lactate, platelets, MAP, etc.) with SeptiCyte RAPID improved performance, yielding an AUC of 0.86.
- Higher SeptiScores consistently correlated with an increased probability of sepsis.
Conclusions:
- SeptiCyte RAPID shows comparable performance in children to that previously observed in adults.
- Real-world effectiveness studies are necessary to establish the clinical utility, patient benefits, and health economic impact of SeptiCyte RAPID in pediatric sepsis management.