Assessment of a Cellular Host Response Test as a Sepsis Diagnostic for Those With Suspected Infection in the Emergency Department

Hollis R. O'Neal, Louisiana State University Health Sciences Center, Baton Rouge, LA.
Roya Sheybani, Cytovale, Inc., San Francisco, CA.
Terrell S. Caffery, Louisiana State University Health Sciences Center, Baton Rouge, LA.
Mandi W. Musso, Louisiana State University Health Sciences Center, Baton Rouge, LA.
Diana Hamer, Louisiana State University Health Sciences Center, Baton Rouge, LA.
Shannon M. Alwood, Louisiana State University Health Sciences Center, Baton Rouge, LA.
Matthew S. Berlinger, Louisiana State University Health Sciences Center, Baton Rouge, LA.
Tonya Jagneaux, Louisiana State University Health Sciences Center, Baton Rouge, LA.
Katherine W. LaVie, Louisiana State University Health Sciences Center, Baton Rouge, LA.
Catherine S. O'Neal, Louisiana State University Health Sciences Center, Baton Rouge, LA.
Michael A. Sanchez, Louisiana State University Health Sciences Center, Baton Rouge, LA.
Morgan K. Walker, Louisiana State University Health Sciences Center, Baton Rouge, LA.
Ajay M. Shah, Cytovale, Inc., San Francisco, CA.
Henry T. Tse, Cytovale, Inc., San Francisco, CA.
Christopher B. Thomas, Louisiana State University Health Sciences Center, Baton Rouge, LA.

Abstract

OBJECTIVES: Sepsis is a common cause of morbidity and mortality. A reliable, rapid, and early indicator can help improve efficiency of care and outcomes. To assess the IntelliSep test, a novel in vitro diagnostic that quantifies the state of immune activation by measuring the biophysical properties of leukocytes, as a rapid diagnostic for sepsis and a measure of severity of illness, as defined by Sequential Organ Failure Assessment and Acute Physiology and Chronic Health Evaluation-II scores and the need for hospitalization. DESIGN SETTING SUBJECTS: Adult patients presenting to two emergency departments in Baton Rouge, LA, with signs of infection (two of four systemic inflammatory response syndrome criteria, with at least one being aberration of temperature or WBC count) or suspicion of infection (a clinician order for culture of a body fluid), were prospectively enrolled. Sepsis status, per Sepsis-3 criteria, was determined through a 3-tiered retrospective and blinded adjudication process consisting of objective review, site-level clinician review, and final determination by independent physician adjudicators. MEASUREMENTS AND MAIN RESULTS: Of 266 patients in the final analysis, those with sepsis had higher IntelliSep Index (median = 6.9; interquartile range, 6.1-7.6) than those adjudicated as not septic (median = 4.7; interquartile range, 3.7-5.9; < 0.001), with an area under the receiver operating characteristic curve of 0.89 and 0.83 when compared with unanimous and forced adjudication standards, respectively. Patients with higher IntelliSep Index had higher Sequential Organ Failure Assessment (3 [interquartile range, 1-5] vs 1 [interquartile range, 0-2]; < 0.001) and Acute Physiology and Chronic Health Evaluation-II (7 [interquartile range, 3.5-11.5] vs 5 [interquartile range, 2-9]; < 0.05) and were more likely to be admitted to the hospital (83.6% vs 48.3%; < 0.001) compared with those with lower IntelliSep Index. CONCLUSIONS: In patients presenting to the emergency department with signs or suspicion of infection, the IntelliSep Index is a promising tool for the rapid diagnosis and risk stratification for sepsis.