Hollis O'Neal, MD: Late Breaking Data on Diagnostic Test for Sepsis IntelliSep

Hollis O'Neal, MD, MSs

Credit: LSU Health

Late-breaking data from an investigation aiming to evaluate the effectiveness of an in-vitro test that measures the viscoelastic properties of leukocytes, as a rapid diagnostic tool for sepsis in the emergency department (ED) was featured at the American Thoracic Society (ATS) 2023 International Conference in Washington, DC,

Lead investigator Hollis O’Neal, MD, MSs, associate professor of medicine, director of research, OLOLRMC,  Louisiana State University Health Sciences Center, shared his insight from his research on the IntelliSep test "Validation of a Rapid Sepsis Diagnostic for Use in Patients Presenting to the Emergency Department With Signs or Suspicion of Infection" in an email interview with HCPLive.

HCPLive: Can you provide an overview of the IntelliSep test and its role in diagnosing sepsis in emergency departments?

Hollis O'Neal: IntelliSep is a first-of-its-kind diagnostic tool helping clinicians recognize sepsis and make critical time-sensitive decisions in as little as ten minutes. The test is pioneering a new way of quickly and accurately analyzing white blood cells to stratify a patient’s risk of sepsis. The test is designed to simply and clearly determine risk of sepsis using a biomechanical evaluation of white blood cells collected from a standard blood draw.

IntelliSep categorizes patients into three risk assessment groups according to their probability of having sepsis, bands one (low probability of sepsis) to three (high probability of sepsis). The results may empower hospitals to optimize clinical outcomes, improve resource utilization and achieve operational excellence.

HCPLive: What makes the IntelliSep test a pioneering technology in the field of medical diagnostics, particularly for fast-moving and immune-mediated diseases?

Hollis O'Neal: The Cytovale IntelliSep test is a semi-quantitative test that assesses cellular host response via deformability cytometry of leukocyte biophysical properties and is intended for use in conjunction with clinical assessments and laboratory findings to aid in the early detection of sepsis with organ dysfunction manifesting within the first 3 days after testing. It is indicated for use in adult patients with signs and symptoms of infection who present to the Emergency Department. The test is performed on an EDTA anticoagulated whole blood sample.

The IntelliSep test generates an IntelliSep Index value that falls within one of three discrete interpretation bands based on the probability of sepsis with organ dysfunction manifesting within the first three days after testing. The test represents the probability of the clinical syndrome of sepsis and is intended to be used alongside other clinical information and clinical judgment. It does not identify the causative agent of infection and should not be used as the sole basis to determine the presence of sepsis.

HCPLive: How does the IntelliSep test compare to existing diagnostic methods for sepsis? What are its advantages and limitations?

Hollis O'Neal: The IntelliSep test is designed to provide critical information about the severity of a patient’s immune response to infection and the risk of sepsis for ED use. It is pathogen agnostic and can provide severity risk information regardless of pathogen. This enables the provider to respond urgently to emergent conditions, then titrate as additional pathogen information becomes available.

Past approaches have focused on specific pathogen ID, which is helpful in identifying the sepsis risk level, but it is not a timely solution. Additionally, it does not look for downstream signs of the consequences of sepsis, which have typically been indicative of inflammation but non-specific to sepsis.