Dual-Biomarker Infection Triage Using PCT and MR-proADM
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Solution Overview
Problem
There is a need for an improved, rapid assessment of patients presenting with infection symptoms to enhance clinical safety and guide therapeutic interventions, particularly in primary care, emergency departments, and intensive care units, as existing methods struggle to accurately differentiate between infectious and non-infectious disorders and predict the risk of complications.
Innovation Solution
A method utilizing the combined assessment of Procalcitonin (PCT) and Midregional-proadrenomedullin (MR-proADM) levels in bodily fluids to classify infection severity and guide clinical decisions, including discharge, hospitalization, and treatment strategies, using defined threshold levels to distinguish between various severity categories.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If only PCT is used for infection assessment, then the assessment is simple and fast, but the precision of differentiation between infectious and non-infectious disorders is insufficient
Solution Approach 1:
The patent combines PCT and proADM into a single dual-marker assessment system. This merging of two biomarkers allows for improved differentiation between infectious and non-infectious disorders while maintaining a streamlined workflow that does not significantly increase operational complexity
Solution Approach 2:
The patent introduces a two-dimensional assessment framework using PCT and proADM as orthogonal markers that capture different aspects of infection pathophysiology. PCT primarily reflects bacterial infection severity while proADM provides additional information about organ dysfunction and mortality risk, creating a more comprehensive diagnostic dimension
2Productivity
If rapid assessment is prioritized, then treatment decisions can be made quickly, but the accuracy of predicting complications and mortality may be reduced
Solution Approach 1:
The patent enables preliminary risk stratification by measuring both PCT and proADM at patient admission. This preliminary action provides immediate information about infection severity and mortality risk, allowing for rapid treatment decisions while maintaining high predictive accuracy through the combined marker approach
3Object-generated harmful factors
If PCT levels are used to guide antibiotic therapy, then antibiotic use is reduced, but patients with early or mild infections may be missed
Solution Approach 1:
The patent uses proADM as a complementary intermediary marker that enhances the sensitivity of infection detection. While PCT guides antibiotic decisions, proADM provides an additional layer of information about overall infection severity and organ involvement, reducing the risk of missing early or mild infections when PCT levels are borderline
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: 1 and/ 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.