Diagnosing Sepsis in the Emergency Department With a New Test: Updated

Sepsis

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Update: Cytovale recently commercially launched the Intellisep, a test designed to help emergency departments quickly diagnose sepsis in adult patients who display signs of infection. The test delivers results in under 10 minutes. Our Lady of the Lake (OLOL) Regional Medical Centerwas the first medical center in the United States to adopt IntelliSep for use in emergency departments. Cytovale plans to introduce the test to the broader Franciscan Missionaries of Our Lady Health System (FMOLHS) network, as well as to an expanded clinical network through the health system's partnership with Louisiana State University. IntelliSep's coverage needs to be extended to hospitals across the nation for early identification of sepsis and patient risk stratification in emergency departments. The company is discussing this with other hospital systems For more information, please see the press release linked here.

A recent cost-consequence analysis in Critical Care Explorations has revealed that utilizing the IntelliSep Index (ISI) for early sepsis diagnosis in the emergency department (ED) is both more effective and less expensive in preventing mortality compared to procalcitonin.

Christopher S. Hollenbeak, PhD, Department Head of Health Policy and Administration and Professor of Surgery and Public Health Sciences at Penn State University, answered questions from Infection Control Today® (ICT®) about the study.

“Sepsis causes 270,000 deaths and costs $38 billion annually in the United States, “according to the authors of the study. “Most cases of sepsis present in the emergency department (ED), where rapid diagnosis remains challenging. The IntelliSep Index (ISI) is a novel diagnostic test that analyzes characteristics of WBC [white blood cell] structure and provides a reliable early signal for sepsis. This study performs a cost-consequence analysis of the ISI relative to procalcitonin for early sepsis diagnosis in the ED.”

ICT: A summary of the key findings and why they are important.

Christopher S. Hollenbeak, PhD, Department Head of Health Policy and Administration and Professor of Surgery and Public Health Sciences at Penn State University,

(Photo courtesy of Cytovale)

Christopher S. Hollenbeak, PhD: Our team performed a cost-consequence analysis to evaluate the health economics of using a new IntelliSep test to inform sepsis care in the ED. In this analysis, IntelliSep was compared to procalcitonin (PCT), a biomarker related to bacterial infection evaluated as a sepsis indicator and performed similarly to the standard of care.

The study supported the hypothesis that using Intellisep as part of the sepsis diagnostic strategy may provide effective reductions in the clinical and financial burden of treating sepsis compared to a procalcitonin diagnostic strategy.

The IntelliSep test could serve as an invaluable element of sepsis care by quickly and efficiently focusing care on those with the highest risk of sepsis while expediting the care of those with lower risk.

ICT: What is the practical application of the key findings for infection preventionists from this study?

CSH: The search for solutions and improvements in sepsis care has become increasingly complicated as the incidence of sepsis continues to rise due to increased awareness, changes in the population's risk profile, such as increasing age and comorbidities, and the impact of the COVID-19 pandemic on pre-existing workforce shortages. Solutions that will safely reduce the cost of care without sacrificing outcomes will require addressing the many factors driving the soaring economic burden of the disease in this new, post-pandemic era of medicine.

This study suggests that risk stratification informed by the IntelliSep test could improve survival for patients with sepsis as compared to that reported with PTC and do so with an expected cost of more than $800 less than that for PCT. This finding is important given that outcomes in sepsis have been proven dependent upon prompt recognition and action.

ICT: What results surprised you, if any?

CSH: One of the more surprising aspects of the study is that an IntelliSep-informed treatment process saves, on average, over $800 per patient tested while also providing a small mortality benefit. This indicates that the IntelliSep test may enable centers to decrease the economic burden of sepsis and achieve better clinical outcomes. And while the study design relies on many assumptions, it is a home run.

ICT: What, if any, future research will there be related to this one

CSH: Great question. This study approximates the health-economic outcomes of using the IntelliSep test to inform clinical care of potentially septic patients. The IntelliSep test recently received FDA Clearance. Applying the test in the care environment will offer another opportunity to capture clinical and financial outcome information and add additional information to this work.

ICT: Is there anything else that you would like to add?

CSH: In our evaluation, the IntelliSep test showed that using the test to inform sepsis care is clinically and economically superior to a strategy informed by PCT. This performance is encouraging, given that the test can be performed in under 10 minutes and utilizes whole blood from a standard EDTA draw. Given its performance and fit within hospital workflows, the trial represents a promising new development in managing sepsis patients.