A Novel Biomarker Aids Sepsis Diagnosis and Care

A Novel Biomarker Aids Sepsis Diagnosis and Care

Part of a routine CBC with differential test, the hematology-based solution is intended to alert emergency department clinicians to sepsis or possible sepsis earlier in the patient care pathway

Rachel Burnside PhD, MBA - Beckman Coulter

For patients with sepsis, every minute counts. Despite great strides in the development of diagnostic tools for sepsis, the condition remains a deadly and costly global healthcare threat.

Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection.1 Without the right treatment, sepsis can progress to septic shock, leading to organ dysfunction and death. Early diagnosis and treatment are key to effective patient care. 

Understanding the human and economic cost of sepsis

Each year, sepsis affects more than 30 million people worldwide, many of whom will lose their battle with the often-deadly condition.2 In the US alone, sepsis is the leading cause of hospitalizations,2 and annual costs related to sepsis total more than $24 billion.3 These figures are only expected to increase, as the incidence of sepsis continues to rise each year at a rate of 1.5 percent.4

Mitigating the human and economic toll from sepsis lies in early diagnosis and treatment. This is complicated by the presence of complex comorbidities and confounding symptoms that can hinder sepsis diagnosis and timely treatment. A delay in the administration of antibiotics in cases of severe sepsis raises the likelihood of death by almost 8 percent per hour.4

Because two-thirds of septic patients enter the healthcare system through the emergency department (ED),2 it is vital to get tools into the hands of acute-care clinicians that give early insight into the possibility of sepsis. 

Gaining ground in the fight against sepsis: The Early Sepsis Indicator

A new tool cleared by the FDA this year offers promise in the ongoing pursuit of a solution to the growing sepsis crisis. The Early Sepsis Indicator is a novel biomarker that provides added value in the identification of sepsis during its early stages when treatment can be most effective.

The Early Sepsis Indicator is intended to give clinicians confidence in assessing sepsis risk as soon as possible after an adult patient enters Emergency Department. The innovative hematology-based biomarker employs proprietary technology that can identify morphological changes in monocytes, cells that play a key role in the dysregulated immune response to sepsis. Monocytes serve as first responders, setting up a first line of defense in the presence of infection. Identifying minute morphological changes in a population of monocytes provides insight into possible sepsis.

By incorporating the Early Sepsis Indicator into their sepsis management strategies, hospitals can anticipate earlier diagnosis, which will, in turn, help physicians make treatment decisions and reduce the cost and care burden caused by this serious condition. 

Besides the clinical advantages, the Early Sepsis Indicator is easily incorporated into established Emergency Department workflows since results are available with a routine CBC with differential for adult patients without any additional test to order. 

Using the Early Sepsis Indicator as part of a comprehensive IVD approach

The Early Sepsis Indicator is not a replacement for, but rather a complement to, the standard of care. It is part of a comprehensive, interdisciplinary approach to sepsis, that offers laboratory technologists and clinicians a range of in vitro diagnostic (IVD) testing modalities and management tools for use throughout the continuum of care, including confirming and/or ruling out diagnosis, monitoring therapy and determining prognosis. The most widely used biomarkers have sufficient sensitivity and specificity for sepsis care; they are C-reactive protein, procalcitonin and lactate, but they require a prior suspicion of sepsis by the physician. The Early Sepsis Indicator acts as an early warning system that can further support patient management and help offset the dangers of sepsis by driving effective patient care early in the care pathway. 


1. Singer M et al. “The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).” JAMA, 2016; 315(8):801-810.

2. Sepsis Alliance. “Fact Sheet.2018.” Sepsis.org. Accessed 6 Mar. 2019.

3. Fingar K. “Trends in Hospital Readmissions for Four High-Volume Conditions, 2009–2013.” https://www.hcup-us.ahrq.gov/reports/statbriefs/sb196-Readmissions-Trends-High-Volume-Conditions.jsp, November 2015. Accessed January 15, 2018.

4. Kumar G, Kumar N, Taneja A, Kaleekal T, Tarima S, McGinley E, Jimenez E, Mohan A, Khan RA, Whittle J, Jacobs E, Nanchal R. "Nationwide trends of severe sepsis in the twenty first century (2000–2007)." Chest, 2011; 16:1223–1231.