We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
PURITAN MEDICAL

Abionic

Abionic SA is a medtech company commercializing a revolutionary nanofluidic technology, providing healthcare professi... read more Featured Products: More products

Download Mobile App




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

By LabMedica International staff writers
Posted on 07 Oct 2024

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. More...

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.”

Related Links:
Abionic


New
Gold Member
Quality Control Material
iPLEX Pro Exome QC Panel
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
Clinical Chemistry System
P780
New
Rapid Molecular Testing Device
FlashDetect Flash10
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








DIASOURCE (A Biovendor Company)

Channels

Hematology

view channel
Image: The microfluidic device for passive separation of platelet-rich plasma from whole blood (Photo courtesy of University of the Basque Country)

Portable and Disposable Device Obtains Platelet-Rich Plasma Without Complex Equipment

Platelet-rich plasma (PRP) plays a crucial role in regenerative medicine due to its ability to accelerate healing and repair tissue. However, obtaining PRP traditionally requires expensive centrifugation... Read more

Immunology

view channel
Image: The 3D paper-based analytical device has shown high clinical accuracy for adult-onset immunodeficiency (Photo courtesy of National Taiwan University)

Paper-Based Device Accurately Detects Immune Defects in 10 Minutes

Patients with hidden immune defects are especially vulnerable to severe and persistent infections, often due to autoantibodies that block interferon-gamma (IFN-γ), a key molecule in immune defense.... Read more

Pathology

view channel
Image: Researchers have developed a novel method to analyze tumor growth rates (Photo courtesy of Adobe Stock)

Novel Method To Analyze Tumor Growth Rates Helps Tracks Progression Between Diagnosis and Surgery

Patients diagnosed with breast cancer often worry about how quickly their tumors grow while they wait for surgery, and whether delays in treatment might allow the disease to spread beyond the point of cure.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.