PREVIA SEPSI SCORE
PREVIA SEPSI SCORE is medical device software intended for use in predicting the risk of developing sepsis in adult hospitalised patients.
The sepsis
Sepsis is a generalised inflammatory response associated with infection. If it occurs after an invasive procedure, it is known as a nosocomial infection. Sepsis can be caused by bacteria or certain viruses (SARS-Cov2, H1N1 influenza, etc.).
Sepsis is currently responsible for 60,000 deaths a year in France and 1 in 5 deaths worldwide. Each hour's delay in diagnosis reduces the patient's chances of survival by 7%.
With a 30-day mortality rate of 20-30%*, sepsis is one of the leading causes of death in hospitals worldwide.
A precise algorithm and real-time alerts can significantly reduce the length of stay and mortality rate.
Digital biomarkers make it possible to collect precise, real-time information about an individual’s state of health. This data is then transmitted and processed electronically, enabling continuous health monitoring, early detection of changes and prediction of health problems.
Objective of the digital biomarker
Data collection
Data pre-processing
Features selection
Model training
Biomarker performance
Clinical validation
PREVIA SEPSI SCORE is intended for use by doctors working in conventional care settings. This software, developed using a machine learning model, analyses structured clinical data from the electronic patient record (EPR) to calculate a sepsis risk score for hospitalised patients. When this score exceeds a predefined threshold, an alert is generated. These results provide risk-based information to assist doctors in monitoring patients at risk of developing sepsis. This device is not intended for the diagnosis of sepsis nor is it intended to replace clinical judgement; it is a decision-support tool for doctors.
PREVIA SEPSI SCORE is contraindicated in paediatric patients (under 18 years of age).
Performance of the PREVIA SEPSI SCORE
The ability to identify patients at risk of developing sepsis before the first symptoms appear
The PREVIA SEPSI SCORE was developed and validated in collaboration with a hospital centre over the course of a 22-month retrospective study. This R&D work led to the publication of an article in the journal Diagnostics in January 2025, entitled ‘Development and Validation of a Machine Learning Model for Early Prediction of Sepsis Onset in Hospital Inpatients from All Departments’.
The study validated our model with a positive predictive value of 0.610, significantly outperforming early warning scores such as SIRS, MEWS and qSOFA. In addition, the model demonstrated high sensitivity and specificity (0.845 and 0.987 respectively), making it possible to accurately predict the risk of developing sepsis before the first clinical signs.
Results of the retrospective study:
85% sensitivity, 99% specificity and 61% positive predictive value.
PREVIA SEPSI SCORE
Integrated into the hospital’s IT workflows, PREVIA SEPSI SCORE’s purpose is to support earlier clinical assessment by providing areal-time risk score computed from routinely collected electronic health record (EHR) data.
Early detection of patients being at risk of sepsis
Alerting healthcare professionals
Risk score calculated every hour
explainability information supporting clinician interpretation
PREVIA SEPSI SCORE is a Class IIb medical device software, bearing the CE mark in accordance with Regulation (EU) 2017/745 on medical devices (MDR).
Notified body: CE 0123
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