IntelliSep Biomarker for Sepsis

IntelliSep (Cytovale) is a point of care test that has been approved by the FDA as a biomarker of sepsis. IntelliSep assesses the cellular host response to sepsis by deformability cytometry of leukocytes.This test is intended for use in adult patients who present to the eD with signs and symptoms of infection and as an aid in the early detection of sepsis with organ dysfunction manifesting within the first three days after testing.

Results are reported as an IntelliSep index (ISI) between 0.10 and 10.0. The results are further stratified into 3 discrete bands. ISI values between 0.1 and 4.9 are classified as band 1, ISI values between 5.0 and 6.2 as band 2, and ISI values between 6.3 and 10.0 as band 3. Patients with sepsis typically have higher ISI and fall into band 3. 

A higher ISI is associated with an increasing probability of sepsis in patients presenting to the emergency department with suspected infection. Patients with a higher ISI had a higher Sequential Organ Failure Assessment and were more likely to be admitted to the hospital compared with those with a lower ISI. 

A study by O’Neal et al, showed that the test had a specificity of 83% and sensitivity of 92% for sepsis when testing patients with signs or symptoms of infection. 

A one year pre and post analysis of more than 34,000 patients with suspected sepsis was presented at the Society of Critical Care Medicine’s (SCCM) 2026 Critical Care Congress. The study was performed at 4 hospital emergency departments. The outcomes included:

• 9% relative reduction in sepsis mortality, driven by earlier identification of high-risk patients and faster initiation of life-saving treatment.
• 22% relative reduction in mortality among patients initially suspected of sepsis who were ultimately not septic. By quickly ruling out sepsis, IntelliSep enabled clinicians to identify and treat the true underlying condition sooner.
• 20% increase in ED discharges with no increase in seven‑day revisit rates.
• 30% decrease in blood culture utilization, concentrated among patients ultimately not diagnosed with sepsis, while maintaining greater than 90% utilization among confirmed sepsis patients

References

O’Neal HR, et al, Cellular host response sepsis test for risk stratification of patients in the emergency department: A pooled analysis, Acad Emerg Med. 2024;31(9):883-893.

Thomas C.B, et al. Impact of a Sepsis Quality Improvement Initiative on Clinical and Operational Outcomes. Healthcare, 2025;13:1273.

Sarani N, et al. Clinical Utility of Recently Food and Drug Administration-Approved IntelliSep Test (Sepsis Biomarker) for Early Diagnosis of Sepsis: Comparison with Other Biomarkers. J Clin Med. 2024 Aug 16;13(16):4852.