FDA has granted premarket notification (510(k)) clearance to the Early Sepsis Indicator from Beckman Coulter, Brea, Calif. Sepsis is a global healthcare crisis that affects more than 30 million people worldwide.1
Beckman’s Early Sepsis Indicator is a first-of-its-kind, hematology-based cellular biomarker that is designed to help emergency department physicians identify patients with sepsis, or those at increased risk of developing sepsis, within the first 12 hours of hospital admission.
As part of the pivotal clinical trial for the Early Sepsis Indicator, findings indicated that Beckman Coulter’s monocyte distribution width biomarker best discriminated sepsis from all other conditions when combined with the current standard of care. The Early Sepsis Indicator is “a novel feature, in that it is exploiting the way in which white blood cell counts are already calculated,” explains Derek Angus, MD, MPH, FRCP, chair of the department of critical care medicine at the University of Pittsburgh Medical Center and a collaborator in the study.
“Sepsis is a leading cause of hospital mortality, and our study findings indicate this simple biomarker test improves the detection of sepsis at an early stage, when it is most responsive to treatment,” says Elliott Crouser, MD, principal investigator in the clinical trial at Ohio State University Wexner Medical Center. “It’s an important breakthrough, and it’ll likely make a big impact in the care of sepsis, as it is easy to implement and works best when combined with other widely available sepsis diagnostic tools at the time of the initial hospital encounter.”
“Early antibiotic treatment of sepsis and septic shock leads to improved patient survival,” says Joseph E. Parrillo, MD, chair of the Heart and Vascular Hospital at Hackensack Meridian Health Hackensack University Medical Center. “Beckman Coulter’s early sepsis indicator helps to identify sepsis patients with proven accuracy, providing the opportunity for clinicians to institute treatment when antibiotics are most effective.”
For adult emergency department patients, results for the Early Sepsis Indicator can be automatically reported as part of a routine complete blood count with differential. A positive Early Sepsis Indicator result signals a higher probability of sepsis, enabling physicians to initiate lifesaving treatments sooner. Conversely, a negative reading indicates a lower probability of sepsis. Compared to reviewing white blood cell count alone, the Early Sepsis Indicator strengthens a clinician’s suspicion of sepsis by 43% and, together with clinical signs and symptoms, improves confidence in helping to rule-out sepsis by 63%.2
“The devastating clinical consequences and financial burden of sepsis are now recognized worldwide,” says Peter Soltani, PhD, senior vice president and general manager of the hematology business at Beckman Coulter. “We are privileged to provide emergency department personnel and clinical laboratorians the tools and information they need to more efficiently recognize sepsis and make treatment decisions as quickly as possible.
“Knowing sooner and acting faster is the name of the game in the fight against sepsis,” adds Soltani. “We believe that the Early Sepsis Indicator has the potential to revolutionize the clinical approach to sepsis triage and diagnosis.”
The Early Sepsis Indicator can be used in conjunction with Beckman Coulter’s proprietary multidisciplinary reflex rules in Remisol Advance middleware. The reflex rules can create customized, automated reflex test panels using Beckman Coulter’s portfolio of in vitro diagnostics related to current sepsis identification and management care pathways across multiple disciplines, including clinical chemistry, hematology, immunoassays, microbiology, and urinalysis.
For further information, visit Beckman Coulter Diagnostics.
- Sepsis fact sheet [online]. San Diego: Sepsis Alliance, 2018. Available at: www.sepsis.org/media-kit. Accessed June 8, 2019.
- Crouser ED, Parrillo JE, Seymour CW, et al. Monocyte distribution width: a novel indicator of sepsis-2 and sepsis-3 in high-risk emergency department patients. Crit Care Med. Epub ahead of print, May 17, 2019; doi: 10.1097/ccm.0000000000003799.