The Sepsis ImmunoScore Predicts Sepsis, Mortality, and Deterioration Better than Clinical Scores and Widely Available Biomarkers

BACKGROUNDEarly identification of patients at risk for sepsis, mortality, and clinical deterioration is essential for improving outcomes, but existing diagnostic and predictive tools have limited accuracy. The objective was to evaluate the performance of an FDA-authorized AI tool, the Sepsis ImmunoScore, compared to widely available biomarkers and clinical tools for diagnosis of sepsis and prediction of in-hospital mortality and intensive care unit (ICU) admission. METHODSThis multicenter observational study included 6,027 adult patients suspected of infection across 7 U.S. hospital sites. The Sepsis ImmunoScores predictive performance was compared to the sequential organ failure assessment (SOFA) score, procalcitonin (PCT), C-reactive protein (CRP), Systemic Inflammatory Response Syndrome (SIRS) score, National Early Warning Score (NEWS), and quick SOFA (qSOFA). Primary outcomes included sepsis as defined by Sepsis-3 criteria, in-hospital mortality, and ICU admission. Predictive accuracy was assessed using area under the receiver operating characteristic curve (AUC), and 95% confidence intervals were generated and hypothesis testing conducted using the bootstrap method. RESULTSThe Sepsis ImmunoScore demonstrated statistically significant superior performance across all outcomes. For sepsis prediction, the Sepsis ImmunoScore achieved an AUC of 0.82, compared to SOFA (0.72), procalcitonin (PCT) (0.70),C-reactive protein (CRP) (0.61), SIRS (0.59), NEWS (0.69), and qSOFA (0.67). For in-hospital mortality prediction, the Sepsis ImmunoScore achieved an AUC of 0.80, outperforming SOFA (0.72), PCT (0.67), CRP (0.58), SIRS (0.60), NEWS (0.72), and qSOFA (0.69). For ICU admission, the Sepsis ImmunoScore reached an AUC of 0.74, superior to SOFA (0.63), PCT (0.64), CRP (0.54), SIRS (0.60), NEWS (0.70), and qSOFA (0.65). All differences between the Sepsis ImmunoScore and comparators were statistically significant. CONCLUSIONSThe Sepsis ImmunoScore significantly improved predictive accuracy for sepsis, in-hospital mortality, and ICU admission compared to six conventional clinical scores and biomarkers. This AI-based tool may enhance risk stratification and clinical decision-making, potentially leading to more timely sepsis interventions and improved outcomes. KEY POINTSO_ST_ABSQuestionC_ST_ABSHow does the FDA-authorized Sepsis ImmunoScore compare to conventional sepsis tools at diagnosing and predicting sepsis, clinical deterioration, and in-hospital mortality? FindingsIn a multicenter observational cohort of 6,027 patients with suspected infection, the Sepsis ImmunoScore demonstrated statistically superior performance compared to PCT, CRP, SOFA, qSOFA, SIRS, and NEWS in predicting all outcomes: sepsis diagnosis, ICU admission, and in-hospital mortality. MeaningBecause the Sepsis ImmunoScore outperforms existing sepsis diagnostics, it could potentially enhance risk stratification and clinical decision-making for patients with suspected infection, enabling more appropriate and timely interventions.