Infectious Disease

Test rapidly determines sepsis probability in patients in emergency department


Cytovale, Inc. funded this abstract. Hollis reports that this project has been funded in whole or in part with federal funds from the Department of Health and Human Services, the Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract number 75A50119C00072.


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Key takeaways:

  • The probability for sepsis in ED patients was given to physicians in less than 10 minutes with the IntelliSep Test.
  • This test could allow physicians to know which patients need more attention and improve care.

WASHINGTON — A test designed to rapidly determine sepsis probability in ED patients suspected of having an infection was found to be reliable, according to an abstract presented at the American Thoracic Society International Conference.

In a prospective, multicenter validation cohort study, Hollis R O’Neal, MD, medical director of research at Our Lady of the Lake Regional Medical Center and critical care physician at LSU Health Sciences Center, and colleagues evaluated 572 ED patients who were suspected of having an infection to see if the odds of sepsis could quickly be determined with the IntelliSep Test (Cytovale), which gives physicians a patients’ probability for sepsis in less than 10 minutes.

Of the total cohort, 152 patients were ultimately diagnosed with sepsis.

Looking across the three interpretation bands into which the test places patients based on their probability for sepsis, researchers found that 79 out of 160 patients in Band 3 (high probability) had sepsis, with a positive predictive value of 49.4% (95% CI, 41.4%-57.4%) and 45 out of 160 patients in Band 2 had sepsis, with a positive predictive value of 28.12% (95% CI, 21.3%-35.8%). In comparison, only 52 (34.2%) of the 152 patients with sepsis were diagnosed with the condition by ED providers, according to the abstract.

Notably, this test received FDA clearance in December 2022, according to a press release from Cytovale.

Healio spoke with O’Neal to learn more about the IntelliSep Test, surprising findings from the study and the impact the findings could have on clinicians.

Healio: How prevalent is sepsis?

O’Neal: Sepsis is responsible for more than 350,000 deaths every year in the United States alone — more than opioid overdoses, prostate cancer and breast cancer combined. Mortality from sepsis increases as much as 8% for every hour that treatment is delayed. As many as 80% of sepsis deaths could be prevented with rapid diagnosis and treatment — making early detection essential.

Healio: What is the Main takeaway from this study?

O’Neal: IntelliSep may aid hospital EDs in saving lives, preventing sepsis-related morbidity, and conserving resources for those who need it most. The tool may also assist hospitals in improving overall patient care and better meet guidelines set by the Centers for Medicare & Medicaid Services (CMS) for timely sepsis treatment.

Healio: Were any of the study findings unexpected or surprising?

O’Neal: The findings are in line with previous published research showing the potential of the IntelliSep test as a groundbreaking diagnostic tool to help clinicians quickly recognize sepsis in busy EDs. The data presented demonstrate the accuracy of IntelliSep in stratifying patients based on their risk of sepsis and death, identifying three statistically distinct bands of sepsis probability from low to high.

We observed that the bands trended strongly with both hospital care metrics and sepsis-based mortality. These data also build on published reports finding the test showed a 97% negative predictive value. That is to say that 97% of those who were categorized as low sepsis probability did not have sepsis upon adjudication. At the same time, about 50% of those who received a high probability score were adjudicated as having sepsis, so there is great potential for the IntelliSep test as an actionable diagnostic tool for sepsis, helping clinicians make critical, time-sensitive decisions and focus their resources where they are most needed.

One surprising aspect of these findings was related to the patient population. The study enrolled during the delta surge of the COVID-19 pandemic. As a result, the patient population featured more acute illness than previous studies as well as viral sepsis. Fortunately, the test proved to be pathogen agnostic, providing clear information regardless of the source of illness.

Healio: Would you briefly characterize what the impact of the findings are for the everyday clinician?

O’Neal: The CV-SQuISH-ED validation study shows the potential for the IntelliSep test to change the way EDs address suspected cases of sepsis. The IntelliSep test aims to provide EDs with a simple, intuitive solution that provides actionable results in 10 minutes or less directly from a standard blood draw. In the ED, every minute counts and resources are strained. Rapid sepsis diagnosis is critical for the millions of patients presenting with signs and symptoms of infection in the ED each year. The lack of a clear indicative sepsis diagnosis test complicates evaluating potentially septic patients. Unlike other time-sensitive conditions (eg, heart attack and stroke), no timely, high-fidelity test has existed to support early sepsis identification — until now.

These data further validate the potential of the IntelliSep test to accurately aid in the early diagnosis of sepsis in the ED when incorporated into existing clinical protocols. This could give physicians actionable information when they need it most, allowing them to confidently triage suspected sepsis patients quickly and spend more time with those in greatest need. It also has the potential to help strained health systems prevent unnecessary treatment, preserve valuable resources and improve compliance with the Severe Sepsis and Septic Shock Management Bundle (SEP-1) guidelines.

Healio: How will future studies be different?

O’Neal: Cytovale, the makers of the IntelliSep test, are planning a number of studies to further evaluate the potential of the IntelliSep test to aid in the rapid diagnosis of sepsis in EDs. These studies will aim to provide information about how the test performs in real-life ED triage situations and highlight how the test might be used to impact clinical and operational outcomes for the ED.

For more information:

Hollis R O’Neal, MDcan be reached at



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American Thoracic Society International Conference

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