Revolutionising Sepsis Diagnosis: The Science and Clinical Impact of Cytovale’s IntelliSep Test

Sepsis remains one of the most critical challenges in emergency medicine, often leading to high mortality rates due to its rapid progression and the necessity for swift intervention. Traditional diagnostic methods, whilst effective, can be time-consuming and sometimes insufficient in the urgent context of an emergency room (ER). Enter Cytovale’s IntelliSep, an innovative In Vitro Diagnostic (IVD) tool that promises to transform sepsis detection with its cutting-edge scientific approach and proven clinical impact.

Understanding Sepsis and the Need for Rapid Diagnosis

Sepsis is a life-threatening condition triggered by the body’s extreme response to an infection. It can lead to tissue damage, organ failure and death if not promptly treated. Early detection is crucial for initiating timely interventions, such as antibiotics and supportive care, which significantly improve patient outcomes. However, diagnosing sepsis swiftly and accurately remains a complex task due to its diverse symptoms and the lack of specific biomarkers.

IntelliSep is a blood-based, semi-quantitative test designed to assess the risk of sepsis in patients presenting to the ER. It leverages advanced technologies in microfluidics, high-speed imaging and machine learning to deliver rapid and reliable results. The scientific principles that make IntelliSep a game-changer in sepsis diagnostics are:

Microfluidics and Deformability Cytometry:

1. Microfluidics: Utilises tiny channels to manipulate and analyse blood samples with precision, allowing for the separation and examination of individual cells.
2. Deformability Cytometry: Measures the mechanical properties of white blood cells as they pass through microfluidic channels. Changes in cell shape and flexibility indicate immune cell activation, a key marker of sepsis.

High-Speed Imaging:

1. Captures detailed images of leukocytes in real-time, providing essential data on cell size, shape and structural integrity to identify abnormal cell behaviours associated with sepsis.

Machine Learning Algorithms:

1. Processes vast amounts of data from imaging and deformability measurements to generate a sepsis risk score ranging from 0.1 to 10. This score integrates various cellular biomarkers and clinical data, offering a comprehensive assessment of the patient’s condition.

IntelliSep offers several significant advantages over conventional sepsis diagnostic tools:

• Speed and Efficiency: Delivers a sepsis risk score in under 10 minutes, compared to traditional methods that can take hours to days.
• Accuracy and Reliability: Enhances diagnostic accuracy by analysing multiple cellular parameters and reducing the likelihood of false positives and negatives.
• Comprehensive Assessment: Provides insights into the severity of sepsis, aiding clinicians in stratifying patients based on their risk levels for tailored treatment strategies.
• Seamless Integration: Designed for easy incorporation into ER workflows, complementing existing clinical assessments and laboratory processes.

To illustrate the real-world impact of IntelliSep, consider its implementation at Our Lady of the Lake Regional Medical Centre in Baton Rouge, Louisiana. This case study highlights how IntelliSep has transformed sepsis diagnosis and management within a high-volume emergency department.

Sepsis affects approximately 1.7 million Americans annually, with related hospitalisation costs exceeding $38 billion each year. Diagnosing sepsis swiftly is challenging due to its variable symptoms and the presence of sepsis mimickers—conditions with similar symptoms that often lead to mis-diagnosis. Existing protocols may not detect early signs of sepsis consistently and regulatory pressures can result in diagnostic variability, impacting patient outcomes and antibiotic stewardship.

In August 2023, Our Lady of the Lake integrated the IntelliSep test into its ER workflow. The hospital had a nurse-driven, triage-based alert system that activates based on vital signs, suspected infection and altered mental status. IntelliSep was seamlessly incorporated, allowing triage nurses to order the test alongside standard diagnostics.

ED Sepsis Workflow with IntelliSep:

1. Triage and Initial Assessment: Patients meeting specific criteria trigger the IntelliSep test.
2. IntelliSep Test Execution: Provides an IntelliSep Index (ISI) score within approximately 8 minutes.
3. Clinical Interpretation and Response:
   • Band 3 (High Risk): Immediate sepsis protocol activation, including antibiotics and blood cultures.
   • Band 2 (Intermediate Risk): Closer monitoring and potential sepsis pathway initiation if needed.
   • Band 1 (Low Risk): Focus on localised infections or alternative diagnoses, reducing unnecessary blood cultures.

90 Days Post-Implementation Findings:

Improved ED Triage:

1. Approximately 50% of IntelliSep results fell into Band 1 (low risk), while 20-25% were in Band 3 (high risk).
2. Rapid identification of Band 3 patients reduced time to intervention by over an hour, significantly lowering mortality risks.

Reduction in Blood Cultures:

1. A 30% reduction in blood culture orders, saving approximately 200-300 cultures monthly.
2. Decreased laboratory workload and material costs, along with saving nursing time for better patient care.

Financial Implications:

1. Achieved an average cost-of-care reduction of around £1,140 per patient tested.
2. Savings resulted from decreased blood culture utilisation, shorter hospital stays and more efficient antibiotic use.

Mortality and Clinical Outcomes:

1. In-hospital all-cause mortality rates decreased across all bands, with the highest risk group (Band 3) seeing a mortality rate of approximately 12.6%, compared to 2.9% in Band 1.
2. Sepsis-associated mortality also increased with higher IntelliSep bands, reinforcing the test’s ability to accurately stratify patient risk.

Despite its promising capabilities, the success of IntelliSep hinges on its acceptance by the medical community. Integrating new diagnostic technologies into established clinical workflows can present challenges, including training requirements and initial implementation costs. Cytovale addresses these hurdles by offering 24-hour technical support and expanding its implementation teams, ensuring that healthcare providers can adopt IntelliSep smoothly and effectively.

Cytovale’s IntelliSep represents a significant advancement in the early detection and management of sepsis. By harnessing the power of microfluidics, high-speed imaging and machine learning, IntelliSep delivers rapid, accurate, and actionable insights that can save lives and reduce the burden on healthcare systems. The successful implementation at Our Lady of the Lake Regional Medical Centre underscores its potential to enhance patient care, optimise resource utilisation and achieve substantial cost savings. As sepsis continues to pose a global health threat, innovations like IntelliSep are essential for improving diagnostic capabilities and patient outcomes in emergency care settings.