Empower Clinicians with Essential Information to Triage Patients Quickly

Sepsis Poses Operational and Cost Challenges for the Lab

78.1 – 93.0

Range in NPV for sepsis from blood cultures, lactate, and procalcitonin, suggesting current tools are insufficient1

90%

Blood cultures do not grow any organisms, suggesting a pattern of over-testing due to
SEP-1 requirements and pressure to
intervene early2 

14B

Clinical lab tests ordered annually in the US3, demanding more from laboratorians as tests become more complex and require faster turnaround times

14%

Vacancy rate in microbiology labs nationally, due to increasing workload and staff burnout4

  1. 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). 
  2. Fabre, et al. Blood Culture Utilization in the Hospital Setting: a Call for Diagnostic Stewardship. J Clin Microbiol. 2022;60(3).
  3. CDC. Strengthening Clinical Laboratories. https://www.cdc.gov/csels/dls/strengthening-clinical-labs.html.
  4. 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

Visibility into patient’s level of immune activation, the biological underpinnings of sepsis, allows for early, accurate and confident detection1

Actionable insights into immune activation allow for more targeted testing, reducing unnecessary blood cultures and contamination rates.2,3

Ordered as part of standardized protocol ensuring tests are ordered for the right patients, optimizing resources and workflow while minimizing unnecessary testing1

Accurate patient risk stratification and reduced unnecessary testing allows labs to focus on their essential role of delivering diagnostic insights that improve patient outcomes

  1. O’Neal HR et al. Pooled analysis. Presented at: Academic Emergency Medicine Annual Meeting; 2024. 
  2. 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.
  3. 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.

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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Lab One-Pager Case Study

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Lab One-Pager Case Study

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