A novel test designed to quantify the state of immune activation by measuring the biophysical properties of leukocytes from a routine blood sample in less than 10 minutes has the potential to rapidly risk-stratify patients independent of pathogen, according to a new study. This finding is important as risk stratification may improve resource allocation in hospitals.

Data from the study shows that the 10-minute IntelliSep sepsis risk stratification test from Cytovale (San Francisco, CA, USA) has the potential to provide useful prognostic information for patients with suspected infection and possible immune dysregulation that can lead to life-threatening organ dysfunction.

The Cytovale system directly analyzes white blood cells using rapid techniques that look at cell structure, making it a faster and less expensive diagnostic compared to gene expression diagnostic systems. Cytovale’s IntelliSep test uses a biomechanical evaluation of white blood cells from a standard blood draw, generating results in under ten minutes. Microfluidic cell-handling techniques combined with the technological advances of high-speed imaging and machine learning allow the Cytovale system to analyze the biophysical properties of thousands of leukocytes in a few seconds, yielding the ISI score. The ISI is a pathogen-agnostic, quantitative measure of immune activation. In patients with suspected infection, elevated ISI indicate a state of immune dysregulation and portend an immediate risk of adverse outcomes, while lower scores portend a less-severe course. The ISI results are stratified into three interpretation bands corresponding to regions of low (Green Band), intermediate (Yellow Band), and high probability (Red Band) of severe outcomes.

The study, which enrolled 282 patients presenting to the Emergency Department (ED) with respiratory symptoms early in the COVID-19 pandemic, aimed to assess the IntelliSep Index (ISI) as a tool for risk stratification of patients with suspected infection presenting to the ED. In the study, 182 (64.5%) patients received a green score, while 54 (18.1%) received a yellow score, and 46 (15.6%) a red score. Patients who received a red score had a 3-day mortality rate of 10.9%, approximately ten-fold higher than the 1.1% 3-day mortality rate experienced by patients receiving a green score. In addition, a lower percentage of green band patients required admission (96 [52.7%]) relative to those receiving yellow (44 [81.5%]) and red scores (43 [93.5%]).

The study reports the performance of this tool as a means to stratify this population for risk of morbidity and mortality resulting from infection with a novel respiratory virus, providing an important test of the value of this host-response technology in assessing severity of illness independent of pathogen type. Data from this study builds on previously published studies that have shown that Cytovale’s IntelliSep test quickly and clearly distinguished sepsis risk in a high-acuity population and helped to identify patients with infections severe enough to cause morbidity and mortality. These data demonstrate the 10-minute test’s potential to aid physicians in rapidly identifying patients at increased risk of having or developing sepsis, a dysregulated immune (white blood cell) response to infection, which is highly lethal and difficult to quickly and accurately diagnose.

“Patients frequently present to the ED with undifferentiated illnesses, forcing clinicians to make rapid, impactful decisions with limited data, often well before a definitive diagnosis is established,” said Cytovale Co-founder and CEO Ajay Shah. “Data from this study published in PLOS ONE demonstrate the potential of the IntelliSep test to assist clinicians in the risk stratification and early direction of care for patients before the results of longer-lead time diagnostic tests are available. This may enable ED providers to triage their own resources and most effectively serve all of their patients.” 

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