sVSIG4 Biomarker for Sepsis Diagnosis and Prognosis
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Solution Overview
Problem
Current biomarkers for diagnosing systemic inflammation, particularly sepsis, are unreliable due to high false-negative rates, complexity in sample preparation, and limited sensitivity, making early diagnosis challenging and therapeutic interventions delayed.
Innovation Solution
The use of soluble V-set and immunoglobulin domain-containing protein 4 (sVSIG4) as a biomarker in biological samples for in vitro diagnosis, allowing for early detection of systemic inflammation and differentiation between sepsis and non-infectious systemic inflammatory reactions without the need for pre-diagnosis or culturing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current biomarkers (PCT, CRP, IL-6) are used for diagnosing systemic inflammation, then the diagnosis can be performed with available markers, but the reliability is insufficient due to high false-negative rates and low positive/negative predictive values
Solution Approach 1:
The patent introduces a novel biomarker (soluble VSIG4 or sVSIG4) that represents a fundamental change in the parameter being measured. Instead of using conventional markers like PCT, CRP, or IL-6, the invention shifts to a completely different protein marker that has been shown to have superior diagnostic performance with area under the curve values of 0.96-0.98, thereby resolving the reliability and predictive value limitations of current markers
Solution Approach 2:
The patent extracts and isolates the specific functional domain of VSIG4 (amino acids 21-283) that serves as the diagnostic biomarker. By focusing on this specific extracellular domain rather than the full protein or other markers, the invention achieves high diagnostic reliability while eliminating the false-negative problems associated with conventional markers
2Reliability
If microbiological methods (culturing) are used to detect pathogens, then pathogen identification can be achieved, but the process is very time-consuming and not reliable due to high false-negative rates
Solution Approach 1:
The patent replaces the mechanical microbiological culturing process with a direct biomarker detection method using ELISA or similar immunoassays. Instead of waiting for pathogen growth in culture media (which takes days), the invention directly measures sVSIG4 levels in patient samples, achieving both high reliability (96-98% accuracy) and rapid results within hours
Solution Approach 2:
The patent performs preliminary detection of the sVSIG4 biomarker immediately upon sample collection, before any culturing or complex processing is attempted. This preliminary action provides rapid diagnostic information that can guide immediate therapeutic decisions, eliminating the time loss associated with waiting for culture results
3Measurement precision
If PCR diagnostics are used for pathogen identification, then targeted and sensitive detection can be achieved, but sample preparation and measurement are time-consuming and require highly experienced staff
Solution Approach 1:
The patent employs disposable ELISA plates and pre-prepared antibodies for sVSIG4 detection, eliminating the need for complex reusable equipment and extensive staff training. The assay uses commercially available reagents and standardized protocols that can be performed by routine laboratory personnel, maintaining high sensitivity while greatly improving ease of operation
Solution Approach 2:
The patent introduces sVSIG4 as an intermediary biomarker that indirectly indicates the presence of systemic inflammation and sepsis. Rather than directly detecting diverse pathogens through complex PCR methods, the invention measures this single intermediary marker that responds to the inflammatory response, simplifying the diagnostic process while maintaining precision
4Speed
If PCT is used as a sepsis marker, then the marker is detectable before CRP increase and rises rapidly after infection, but major surgery, polytrauma, and cardiogenic shock also result in markedly elevated PCT concentrations, reducing general applicability
Solution Approach 1:
The patent exploits the local quality difference in sVSIG4 expression patterns between infectious and non-infectious conditions. While PCT elevations are non-specific and occur in both sepsis and non-infectious inflammation, sVSIG4 shows distinct elevation patterns that are specifically associated with infectious etiologies, allowing the marker to maintain both rapid response and high adaptability across different clinical scenarios
Data Source
AI summary
The present invention relates to the field of in vitro diagnosis of a systemic inflammation or prognosis of a risk of mortality of a subject with a systemic inflammation. In another aspect, the invention relates to the field of monitoring a systemic inflammation. The invention further relates to the use of a biomarker for in vitro diagnosing a systemic inflammation in a subject or prognosing a risk of mortality of a subject with a systemic inflammation. In particular, the biomarker is soluble V-set and immunoglobulin domain-containing protein 4 (sVSIG4). Preferably, the systemic inflammation is caused by an infectious agent, more preferably is a sepsis.