Cut through the Clinical Uncertainty with a
Sepsis is a Medical Emergency that is Common, Costly, and Difficult to Diagnose
Misdiagnosis and delayed treatment may lead to serious consequences for patients and hospitals.
80% of sepsis deaths could be prevented with a rapidsepsis test that aids in sepsis diagnosis4
- AHRQ. Most Expensive Hospital Conditions, 2017. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb261-Most-Expensive-Hospital-Conditions-2017.jsp.
- Wang HE, Jones AR, Donnelly JP. Revised national estimates of emergency department visits for sepsis in the United States. Crit Care Med. 2017;45:1443-1449.
- Gaddis ML, Gaddis GM. Detecting sepsis in an emergency department: SIRS vs. qSOFA. Mo Med. 2021 May-Jun;118(3):253-258. PMID: 34149086.
- Kumar A, Roberts D, Wood KE, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006;34(6):1589-1596.
Unlike Other Time-Sensitive Medical Emergencies, Sepsis Lacked a Highly Sensitive Diagnostic Test.
Until Now.
Like heart attack and stroke, there is now an objective detection tool for sepsis, supporting rapid diagnosis and treatment.
Kumar A et al. Duration of hypotension prior to initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Critical Care Medicine. 2006;(34):1589-1596.
Now You Can Identify which Patients are at Risk of Developing Sepsis during ED Triage
IntelliSep is an In Vitro Diagnostic Test for Sepsis with Clear, Actionable Results
In about 8 minutes IntelliSep delivers clinically actionable results, risk-stratifying patients based on their probability of having sepsis.
Results are presented as a numerical value between 0.1 and 10.0, which is further stratified into 3 discrete bands. Patients with sepsis typically have higher scores and fall into Band 3.
IntelliSep helps the ED accelerate the time to diagnosis and treatment, patient disposition, and throughput.
*All results should be interpreted in the context of the other clinical observations and laboratory test results for the patient
Pathogen-Agnostic
Host response approach assesses white blood cells to detect sepsis due to any pathogen
Fits ED and Lab Workflows
100uL from a standard ‘purple-top’ K2 EDTA blood collection tube
Rapid Results
~ 8 minutes blood test, from tube-to-score
Diagnostic Confidence
Sepsis probability score extends out to 3 days
Seamless Information Communication
Results automatically delivered to LIS at the end of each run
Performance Highlights
- 1,002 adult patients with signs or suspicion of infection presenting to the ED, spanning 5 adult cohorts from separate observational studies
- Performance was compared to retrospective physician adjudication of sepsis blinded to the IntelliSep results
- Zero 30-day in-hospital sepsis-associated mortality in Band 1 patients
- Diagnostic performance provides confidence for the next 3 days
IntelliSep is a reliable in vitro diagnostic test to aid in the rapid diagnosis and risk stratification of sepsis in patients who present to the ED with signs and suspicion of infection
O’Neal HR et al. Pooled analysis. Presented at: Academic Emergency Medicine Annual Meeting; 2024.
Application of Early Sepsis Detection Begins in Triage
Incorporating IntelliSep into your ED workflow to test for sepsis will lead to
more accurate and timely diagnosis and treatment.
*The above decision-making notes are based on one site’s institutional practices and validation of IntelliSep. See the IntelliSep Test Instructions for Use for all cleared claims and performance data.
1. O’Neal HR et al. Pooled analysis. Presented at: Academic Emergency Medicine Annual Meeting; 2024.
Frequently Asked Questions
Intellisep test
1. What is a diagnostic test for sepsis?
There are many types of tests that can be used to help diagnose sepsis, including blood tests as well as imaging tests. There are a few types of blood tests that are most commonly used–biomarkers (e.g. lactate, PCT, CBC), host response diagnostics (e.g. IntelliSep), and pathogen identification tests (e.g. blood cultures). Imaging tests such as x-rays, CT scans, and ultrasounds typically help identify the source of infection. These tests range in their accuracy and speed.
2. How does IntelliSep detect sepsis?
The IntelliSep test detects sepsis by analyzing biophysical changes in white blood cells that occur early in the immune response to infection and signal risk for sepsis.
The IntelliSep test is run on the Cytovale System with a small blood sample. Using microfluidics and deformability cytometry, the Cytovale System interrogates tens of thousands of cells to observe changes in biomechanical properties. Ultra-high resolution imaging captures images of the cells during the interrogation process. Then, the Cytovale System uses high-throughput image analysis and machine learning to examine biologically relevant features in cell images, translating them into a score that reflects the probability of sepsis. Results are further stratified into three bands where Band 1 represents low probability and Band 3 represents high probability of sepsis.
3. What sets IntelliSep apart from other rapid sepsis tests?
IntelliSep is the first and only test FDA cleared for sepsis detection. Unlike traditional diagnostics that focus on identifying pathogens or measuring biomarkers, IntelliSep detects sepsis based on biophysical changes in immune cells that occur in response to systemic infection. IntelliSep gives providers a new way to understand sepsis and detect it earlier and more accurately than ever possible before.