PCT and MR-proADM Workflow for Infection Risk Stratification
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Solution Overview
Problem
There is a need for an improved, fast assessment of patients presenting with signs of infection or increased risk factors to enhance patient safety and guide appropriate treatment decisions, particularly in primary care, emergency departments, and intensive care units, as existing methods struggle to accurately differentiate between infectious and non-infectious disorders and manage the risk of complications.
Innovation Solution
A method involving the determination of Procalcitonin (PCT) and Midregional Proadrenomedullin (MR-proADM) levels in bodily fluids, using specific threshold combinations to classify infection severity and guide clinical decisions, including discharge, hospitalization, and treatment strategies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If PCT levels are used to assess infection severity, then bacterial infection detection is improved, but differentiation between infectious and non-infectious disorders remains insufficient
Solution Approach 1:
The patent combines PCT and proADM measurements into a unified assessment system. By measuring both biomarkers simultaneously and evaluating their combined levels, the method achieves better differentiation between infectious and non-infectious disorders than either marker alone, resolving the contradiction between improved infection detection and sufficient differentiation accuracy.
Solution Approach 2:
The dual-marker system serves multiple functions: it detects bacterial infections, assesses infection severity, differentiates infectious from non-infectious causes, and predicts patient outcomes. This multi-functionality allows a single diagnostic approach to address multiple clinical questions simultaneously, improving both measurement precision and reliability.
2Reliability
If comprehensive patient assessment is performed, then patient safety and treatment accuracy are improved, but assessment time and complexity increase
Solution Approach 1:
The patent measures proADM and PCT levels early in the clinical workflow, before final treatment decisions are made. This preliminary assessment provides immediate risk stratification information that guides subsequent clinical actions, allowing comprehensive evaluation without delaying critical treatment decisions.
Solution Approach 2:
The method uses specific threshold values for PCT and proADM levels to simplify complex clinical judgment into actionable categories. By establishing clear parameter thresholds (e.g., proADM >1.5 nmol/L indicating high risk), the system maintains comprehensive assessment quality while enabling rapid clinical decision-making.
3Object-generated harmful factors
If antibiotic treatment is administered based on PCT levels, then inappropriate antibiotic use is reduced, but early bacterial infections may be missed
Solution Approach 1:
The patent introduces proADM as an intermediary marker that enhances the sensitivity of infection detection. While PCT alone may miss early or localized infections, proADM provides additional diagnostic information that acts as a mediator to identify cases requiring antibiotic treatment, thereby reducing false negatives without contributing to antibiotic overuse.
Solution Approach 2:
The method applies antibiotic treatment recommendations based on combined PCT and proADM levels rather than PCT alone. This partial action approach treats only those patients who meet specific dual-marker criteria, ensuring appropriate antibiotic use while capturing early infections that would be missed by PCT monitoring alone.
Data Source
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AI summary
The present invention is in the field of clinical diagnostics. Particularly, the present invention relates to the assessment of severity of a subject being suspected of an infection or having an infection, who may have physiological signs or increased risk factors for infection, in particular from an infectious disease by determination of the levels of Procalcitonin (hereinafter: PCT) (SEQ ID No: 1and/ or proadrenomedullin (hereinafter: proADM)) (SEQ ID No: 3) or a partial peptide or fragment thereof, in particular midregional proadrenomedullin (MR-proADM) (SEQ ID No: 2), in a sample of a patient and the invention is related to a workflow hereto. Moreover, the invention refers to the assessment related to an infection like ruling out/in a patient and stratification, risk assessment, in particular to avoid rehospitalisation and hospital and post- discharge mortality.