Empower Clinicians with Essential Information to Triage Patients Quickly
Sepsis Poses Operational and Cost Challenges for the Lab
no GOLD STANDARD FOR SEPSIS DETECTION
78.1 – 93.0
Range in NPV for sepsis from blood cultures, lactate, and procalcitonin, suggesting current tools are insufficient1
EXCESS RESOURCE UTILIZATION
90%
Blood cultures do not grow any organisms, suggesting a pattern of over-testing due to
SEP-1 requirements and pressure to
intervene early2
BURDEN FROM GROWING VOLUME OF LAB TESTS
14B
Clinical lab tests ordered annually in the US3, demanding more from laboratorians as tests become more complex and require faster turnaround times
HIGH ATTRITION RATE AMONG LAB STAFF
14%
Vacancy rate in microbiology labs nationally, due to increasing workload and staff burnout4
- O’Neal, et al. Assessment of a Cellular Host Response Test as a Sepsis Diagnostic for Those With Suspected Infection in the Emergency Department. Crit Care Explor. 2021;3(6).
- Fabre, et al. Blood Culture Utilization in the Hospital Setting: a Call for Diagnostic Stewardship. J Clin Microbiol. 2022;60(3).
- CDC. Strengthening Clinical Laboratories. https://www.cdc.gov/csels/dls/strengthening-clinical-labs.html.
- Edna Garcia, et al. The American Society for Clinical Pathology 2022 Vacancy Survey of Medical Laboratories in the United States. Am J Clin Path. 2024;161(3).
All results should be interpreted in the context of the other clinical observations and laboratory test results for the patient
IntelliSep Now Offers Early Sepsis Detection with Clear, Actionable Results
IntelliSep is a diagnostic tool that risk-stratifies patients based on their probability of having sepsis, providing results in about 8 minutes. The test equips your ED staff with the information that they need to deliver the right care, to the right patient, at the right time.
IntelliSep is an FDA-cleared in vitro diagnostic test for adult patients with signs and symptoms of infection who present to the Emergency Department
Expected Impact of IntelliSep
EARLY AND ACCURATE SEPSIS DETECTION
Visibility into patient’s level of immune activation, the biological underpinnings of sepsis, allows for early, accurate and confident detection1
increased SEP-1 COMPLIANCE
Actionable insights into immune activation allow for more targeted testing, reducing unnecessary blood cultures and contamination rates.2,3
OPERATIONAL EFFICIENCY AND APPROPRIATE RESOURCE ALLOCATION
Ordered as part of standardized protocol ensuring tests are ordered for the right patients, optimizing resources and workflow while minimizing unnecessary testing1
IMPROVED LAB STAFF SATISFACTION AND RETENTION
Accurate patient risk stratification and reduced unnecessary testing allows labs to focus on their essential role of delivering diagnostic insights that improve patient outcomes
- O’Neal HR et al. Pooled analysis. Presented at: Academic Emergency Medicine Annual Meeting; 2024.
- Thomas CT et al. Evaluation of early-stage implementation results of a cellular host-response test in an emergency department setting. Presented at ESCMID; April 2024; Barcelona, Spain.
- T Jagneaux, et. al. Expediting Identification of Occult Sepsis with a Novel Diagnostic for Patients Presenting to the ED with Possible Infection. Presented at Association for Diagnostics and Laboratory Medicine (ADLM); 2024.
Sepsis Detection Designed for the Modern Laboratory
Application of IntelliSep begins in ED triage. Incorporating IntelliSep offers an objective measure for identifying patients’ risk of sepsis, leading to more accurate and timely diagnosis and treatment. IntelliSep is powered by the 510k cleared CLIA-Moderate Cytovale System.
Product Specifications
- 4 ft bench space per system
- 1-week installation
- No calibration required
- PM every 90 days
- No vacuum or plumbing required
IntelliSep Sepsis Test Fits in Seamlessly with Lab Workflow
Beginning in ED triage, the IntelliSep sepsis test provides a critical, objective measure of sepsis risk, enabling more precise and timely diagnosis and treatment.
The Cytovale System isolates, images, and analyzes cells
information communication setup
Streamlined Information Communication with
Your LIS
The Cytovale System, a laboratory benchtop analyzer, is designed to integrate with existing lab workflows. Setup is straightforward, requiring only an ethernet connection to the hospital middleware.
The Cytovale System does not connect to the internet. Cytovale is prepared to assist your IT staff with MDS2 documentation and cybersecurity compliance activities.
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Nate Ledeboer, PhD
Associate professor in Pathology & Laboratory Medicine at the Medical College of Wisconsin
From Test to Treatment: Clinical Interpretation, Rationale, and Impact of the IntelliSep Sepsis Test
Case Study
Our Lady of the Lake
Regional Medical Center
IntelliSep has been seamlessly integrated into clinical workflows at Our Lady of the Lake Regional Medical Center. It has improved triage for patients with suspected sepsis, reducing time to diagnosis, and allowing for more efficient use of antibiotics and blood cultures, thereby optimizing resource utilization. These streamlined processes and care pathways have resulted in substantial clinical benefit as well as cost savings. This document presents a detailed exploration of Our Lady of the Lake Regional Medical Center’s strategy to address sepsis in the ED, improve triage, and develop an effective clinical interpretation and application of the test.
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Case Study
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Case Study
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