IVD CAPSULE PSP

The IVD CAPSULE PSP is a rapid, single-use in vitro diagnostic test for the quantitative measurement of pancreatic stone protein (PSP) in blood. The test is intended to be used in conjunction with other clinical assessments and laboratory findings to aid in the early detection of nosocomial sepsis in adults.

Pancreatic Stone Protein (PSP) on the abioSCOPE® is the Earliest Marker of Sepsis

Sepsis is a major healthcare burden claiming more than 11 million lives per year, one death every 2.8 seconds¹. It is caused by a dysregulated host response to infection which can progress to multiple organ dysfunction, septic shock and death. It’s a medical emergency that requires immediate diagnosis. Unfortunately, current standards of care often lead to sepsis being diagnosed too late.

Every hour antibiotic therapy is delayed, the chances of survival decrease by 8%²

The clinical signs and symptoms of sepsis are generic and non-specific, making it extremely challenging to timely identify. The availability of an early and accurate biomarker at the patient’s bedside is key to enabling faster treatment decisions, reduce mortality and lower sepsis-related healthcare costs.

EARLY SEPSIS DETECTION UP TO 72 HOURS BEFORE THE STANDARD OF CARE IN 5 MIN*

The PSP Test on the abioSCOPE® Can Save Millions of Lives

The IVD CAPSULE PSP on the abioSCOPE® is the first CE-marked in vitro diagnostic test to enable fast, reliable and early sepsis detection at the point-of-care from a single drop of blood in only 5 minutes*.

A multicentric study published recently in Critical Care, proves that bedside measurement of PSP on the abioSCOPE® clearly correlates with the onset of sepsis, enabling personalized clinical management of patients in the ICU³.

An increasing PSP concentration in the days preceding the clinical diagnosis of sepsis, offers a unique window of opportunity for clinicians to initiate timely the right treatment.

IVD CAPSULE PSP ON THE ABIOSCOPE DESIGNED FOR ON-DEMAND USE IN THE ICU

Scope of Use for the PSP Biomarker in the Diagnosis of Sepsis in Adults

• Early Diagnosis of Nosocomial Sepsis³
• Diagnosis of Sepsis in Patients with Severe Burns⁴
• Diagnosis of Sepsis in Patients with Polytrauma⁵
• Post–Cardiac Surgery Monitoring⁶
• Diagnosis of Sepsis upon ICU admission⁷

Compact, robust, and intuitive to use, Abionic’s PSP test on the abioSCOPE® is fully compatible with hospital information systems and fits seamlessly into the workflow. When sepsis is suspected, an immediate access to reliable test results is essential. Serial bedside PSP

measurements every 24 hours can aid the clinical management and early identification of sepsis in patients at risk. A constantly low PSP value is also a strong indicator of a patient's stability, supporting the decision to not start or withhold unnecessary antibacterial treatment.

References:

1. Global Sepsis Alliance; https://www.global-sepsis-alliance.org/sepsis
2. Improving time to antibiotics and implementing the "Sepsis 6". McGregor C. et al., BMJ Open Quality. 2014; https://bmjopenquality.bmj.com/content/2/2/u202548.w1443
3. Serial measurement of pancreatic stone protein for the early detection of sepsis in intensive care unit patients: a prospective multicentric study. Pugin et al., Crit Care. 2021 Apr 20; https://pubmed.ncbi.nlm.nih.gov/33879189/
4. Pancreatic Stone Protein Predicts Sepsis in Severely Burned Patients Irrespective of Trauma Severity: A Monocentric Observational Study. Klein et al., Annals of Surgery. 2020; https://pubmed.ncbi.nlm.nih.gov/31972652/
5. Pancreatic stone protein is highly increased during posttraumatic sepsis and activates neutrophil granulocytes. Keel et al., Crit Care Med. 2009; https://pubmed.ncbi.nlm.nih.gov/19325491/
6. Pancreatic stone protein predicts postoperative infection in cardiac surgery patients irrespective of cardiopulmonary bypass or surgical technique. Klein et al., PloS one, 2015; https://pubmed.ncbi.nlm.nih.gov/25793700/
7. Sepsis biomarkers in unselected patients on admission to intensive or high-dependency care. Llewelyn et al., Crit Care. 2013; https://pubmed.ncbi.nlm.nih.gov/23531337/

* IVD CAPSULE PSP on the abioSCOPE® measurment time: 5 minutes; Total Assay time: 7.5 minutes.