Study Shows Patients With Abnormal Values of Beckman Coulter's Novel MDW Biomarker Are Four- To Six- Times More Likely to Be Diagnosed With (Or Develop) Sepsis
BREA, Calif., Aug. 5, 2020 /PRNewswire/ -- Beckman Coulter today announced new analysis from the pivotal study of its novel monocyte distribution width (MDW) hematologic biomarker for sepsis detection. The analysis showed that abnormal MDW values, when considered along with the standard physiologic parameters at the time of patient presentation in the emergency department, signifies a four- to six-times higher probability of sepsis diagnosis. The pivotal study enrolled 2,158 Emergency Department patients in three leading academic centers and was a basis for FDA clearance of Beckman Coulter's Early Sepsis Indicator.
The analysis was recently published in the Journal of Intensive Care titled, "Monocyte distribution width enhances early sepsis detection in the emergency department beyond SIRS and qSOFA".
"We took a unique approach to the study and analyzed the results from the perspective of the front-line Emergency Department physicians and staff, whose job it is to quickly assess whether the patient is septic, or at risk of turning septic, and initiate treatment," said Elliott Crouser, M.D., professor of Critical Care Medicine at Ohio State University Wexler Medical Center and principal investigator in the study. "The value of MDW is that it provides physicians with an earlier indication of sepsis during the initial encounter, which is especially important when a patient's symptoms are mild and alternative diagnoses are being considered."
SIRS and qSOFA risk scores are routinely used for assessing the risk of sepsis based on the standard physiologic parameters such as body temperature, respiration rate, heart rate, blood pressure, and altered mental status, among others. Both were initially derived for use in the Critical Care environment and may lack sensitivity and specificity in Emergency Department patients. The study found that the routine use of MDW in conjunction with the scores, brings an appreciable diagnostic benefit.
"In the Emergency Department, we are trained to focus on the most life-threatening conditions first — like MIs, strokes and now COVID-19. Although deadly, early symptoms of sepsis can be very subtle," said Tiffany Osborn, M.D., professor of Surgery and Emergency Medicine at Washington University. "Having an ancillary test as a part of our standard CBC workup that adds early, diagnostic value to traditional clinical acumen is very helpful."
Researchers conducting the study also proposed the clinical role of MDW to supplement current clinical parameters used to screen for sepsis. In essence, this could potentially serve as a fifth SIRS criteria or a fourth qSOFA criteria, to enhance the early detection of sepsis in the Emergency Department*.
The novel MDW hematologic biomarker (or Early Sepsis Indicator) is available on the Beckman Coulter DxH 900 and DxH 690T hematology analyzers as a part of a CBC with Differential. For more information about MDW and Beckman Coulter's robust portfolio of sepsis diagnosis and management solutions, visit www.beckmancoulter.com/sepsis.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory's role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation (NYSE: DHR) since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
*Not cleared by the US FDA. Additional data is required through a validated clinical trial to establish clinical utility.
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SOURCE Beckman Coulter Diagnostics