POC Sepsis Test Delivers Fast, Accurate and User-Friendly Results in Critical Care Settings

Sepsis is a critical global health issue, impacting 50 million people annually and causing 11 million deaths, which accounts for 20% of all global fatalities. Sepsis is an emergency where time is of the essence, and up to 80% of sepsis-related deaths are preventable. However, it remains notoriously difficult to diagnose due to its non-specific symptoms, which often mimic other common conditions. Early detection is essential for initiating the appropriate treatment protocols and improving patient survival rates. Pancreatic Stone Protein (PSP) has emerged as a promising biomarker for the early detection of sepsis, identifying the condition 24-48 hours earlier than current methods. PSP, produced by the pancreas and immune cells, rises in response to infection and inflammation and has shown significant sensitivity and specificity in detecting sepsis, particularly in critically ill patients. Clinical studies have found that elevated PSP levels are closely linked to the progression of sepsis, enabling healthcare providers to initiate life-saving treatments sooner and improve patient outcomes.

Abionic (Epalinges, Switzerland) has developed the IVD CAPSULE PSP test, which offers rapid, accurate, and easy-to-use results in critical care settings by measuring PSP levels. These measurements are directly tied to a patient's sepsis risk, empowering clinicians to make well-informed decisions and initiate timely treatments. The IVD CAPSULE PSP operates exclusively on Abionic’s abioSCOPE platform, a near-patient rapid diagnostic system that integrates smoothly into clinical workflows. It provides lab-quality results from a drop of blood within minutes, delivering valuable insights and actionable information directly at the point of care.

To perform the test, a trained healthcare provider can obtain 50 μL of capillary blood via a simple finger prick without the need for a phlebotomist to collect venous blood. The sample is placed into an abioMIX tube, shaken 10 times for even mixing, and then applied to the capsule. The biomarker levels are quickly measured with high precision and accuracy, delivering lab-quality results within minutes at the point of care. The IVD CAPSULE PSP test has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA), expediting the detection of sepsis. Already certified under the EU IVDR as of July 2022, this FDA approval allows Abionic to expand into the U.S. market.

“Achieving FDA 510(k) clearance for IVD CAPSULE PSP marks a significant milestone for Abionic and confirms our ability to meet the need for quick & reliable sepsis testing,” said Patrick Pestalozzi, CEO at Abionic. “This clearance will allow us to deploy our solutions across the United States and provide clinicians in acute care settings with a proven solution to accelerate the Time-To-Detection of sepsis.”

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