Roya Sheybani, PhD
Associate Director Clinical Affairs
Cytovale, United States
Disclosure information not submitted.
Terrell Caffery, MD, FACEP
Academic Section Chief, Associate Professor
LSU Emergency Medicine, United States
Disclosure information not submitted.
Mandi Musso, PhD
Academic Research Director
Our Lady of the Lake Regional Medical Center, United States
Disclosure information not submitted.
Diana Hamer, PhD
Academic Research Director
Our Lady of the Lake Regional Medical Center, United States
Disclosure information not submitted.
Shannon Alwood, MD
EM program director, Assistant Prof.
LSUHSC, United States
Disclosure information not submitted.
Tonya Jagneaux, MD
Associate Prof.
Louisiana State University, United States
Disclosure information not submitted.
Catherine O’Neal, MD
Assistant Professor of Clinical Medicine
Louisiana State University Health Sciences Center, United States
Disclosure information not submitted.
Ajay Shah, PhD
President & CEO
CytoVale, Inc.
San Francisco, California, United States
Disclosure information not submitted.
Henry Tse, PhD
CTO
CytoVale, Inc.
San Francisco, California, United States
Disclosure information not submitted.
Christopher Thomas, MD
Assistant Prof.
Louisiana State University Health Sciences Center, United States
Disclosure information not submitted.
Title: Rapid Cellular Host Response Test for Risk Stratification of ED Patients with Confirmed Infection
Introduction/Hypothesis: Patients presenting to the Emergency Department with an infection, whether bacterial or viral, experience a range of unpredictable clinical courses, with a significant number at risk of progressing to critical illness and death. Currently, no rapid diagnostics exist with clinically actionable performance for risk stratification of such patients and ED clinicians must balance the benefits of early intervention against the risks of indiscriminate use of resource-intensive interventions. The objective of this study was to assess the potential of IntelliSep test to stratify such a population for risk of poor outcomes.
Methods: The IntelliSep test is an investigational in vitro diagnostic that quantifies the state of immune activation by measuring the biophysical properties of leukocytes from a routine blood sample in under 10 minutes. The test provides a single score, the IntelliSep Index (ISI), between 0.1-10.0 (inclusive), stratified into three discrete interpretation bands of risk for disease severity: Green, Yellow, and Red. Adult patients presenting to the ED with signs or suspicion of infection (2+ SIRS or order for cultures) were prospectively enrolled at multiple sites in the USA (Feb. 2016 – Sept. 2019). EDTA-anticoagulated blood was assayed within 3 hours of draw, and patients were followed by retrospective chart review for outcome information. Presence of infection was determined by physician adjudication, and only those infected were included in the final analysis. ISI trends with severity of illness metrics and hospital-based outcomes were assessed.
Results: 237 infected patients were stratified by the ISI as 78 (33%) Green, 60 (25%) Yellow, and 99 (42%) Red. ISI bands correlated strongly with severity of illness metrics (SOFA, APACHE II, PIRO), positive blood cultures, and the need for ICU admission. Significant differences in mortality were observed across the bands (0.0% in Green vs. 15.2% in Red; p < .001). Among survivors, Green Band patients had significantly lower hospital length of stay (p < .001). Risk-stratification of patients was independent of demographic groups (age, sex, race).