Beckman Coulter, Brea, Calif, has filed a premarket notification (510(k)) submission with FDA for its Early Sepsis Indicator. The first-of-its-kind hematology-based solution gives clinicians insight into the possibility of sepsis or risk of developing sepsis in patients in acute care settings.
Offered as part of a standard CBC with differential screen, the test provides results in less than 1 hour without additional workflow burden for clinicians or clinical laboratories. The Early Sepsis Indicator was recently granted the European CE mark, and is commercially available in select countries for use with the company’s newly released DxH 900 hematology analyzer.
Sepsis is a global healthcare crisis affecting 26 million people worldwide every year, and is increasing at a rate of 1.5% annually.1,2 Sepsis significantly affects patients and their loved ones and also places considerable clinical and economic burden on the healthcare system.3 The availability of timely, accurate detection solutions in the emergency department where providers can initiate treatment is critical to stopping the progression of this life-threatening condition. Early treatment is important because patients with less-severe sepsis can progress to severe sepsis or septic shock within 72 hours, and up to half of patients with sepsis die.2,4,5 There is a clear link between the timeliness of treatment and mortality.6
“We want to give clinicians in the emergency department a simple tool to help them identify sepsis quickly, shortening time to treatment for these critical patients,” says Peter Soltani, PhD, senior vice president and general manager of the hematology business at Beckman Coulter. “Getting actionable clinical information to emergency department physicians sooner can speed critical treatment decisions.”
The Early Sepsis Indicator uses the DxH 900 hematology analyzer’s enhanced Coulter technology, which offers near native-state cellular characterization. In addition, the company’s VCS 360 technology uniquely detects morphological changes in monocyte cells that play a role in the dysregulated immune response to sepsis. Detecting these morphological changes identifies possible sepsis earlier than other indicators.
To learn more, visit Beckman Coulter.
- Sepsis Fact Sheet [online]. San Diego, Sepsis Alliance, 2018. Available at: www.sepsis.org/faq. Accessed August 5, 2018.
- Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013;369(9):840–851; doi: 10.1056/nejmra1208623.
- Torio CM, Moore BJ. National inpatient hospital costs: the most expensive conditions by payer, 2013 [statistical brief 204, online]. Rockville, Md: Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality, 2016. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb204-most-expensive-hospital-conditions.jsp. Accessed August 5, 2018.
- Glickman SW, Cairns CB, Otero RM, et al. Disease progression in hemodynamically stable patients presenting to the emergency department with sepsis. Acad Emerg Med. 2010;17(4):383–390; doi: 10.1111/j.1553-2712.2010.00664.x.
- Engel C, Brunkhorst FM, Bone HG, et al. Epidemiology of sepsis in Germany: results from a national prospective multicenter study. Intensive Care Med. 2007;33(4):606–618; doi: 10.1007/s00134-006-0517-7.
- Kumar A, Roberts D, Wood KE, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006;34(6):1589–1596; doi: 10.1097/01.ccm.0000217961.75225.e9.