Serum Marker Panel for Non-Invasive ASH and NASH Diagnosis
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Solution Overview
Problem
Current methods for diagnosing alcoholic steato-hepatitis (ASH) and non-alcoholic steato-hepatitis (NASH) are inadequate, relying on invasive and costly liver biopsies, and lack accurate non-invasive tests for precise diagnosis, especially in patients with liver fibrosis or necroinflammatory lesions.
Innovation Solution
A diagnostic method using a combination of serum biochemical markers, including ApoA1, ALT, AST, alpha-2-macroglobulin, GGT, total bilirubin, and haptoglobin, analyzed through a logistic function to assess the presence and severity of ASH or NASH, reducing the need for liver biopsies by providing high predictive values.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If liver biopsy is used for diagnosis, then diagnostic accuracy is improved, but invasiveness and cost increase
Solution Approach 1:
The patent creates a non-invasive diagnostic copy of the liver biopsy procedure by using a panel of serum biochemical markers (ApoA1, ALT, AST, alpha-2-macroglobulin, GGT, total bilirubin, haptoglobin) that replicate the diagnostic information obtainable through biopsy without requiring actual tissue sampling. This copying approach maintains diagnostic accuracy while eliminating the invasive nature of biopsy.
Solution Approach 2:
The patent replaces the mechanical invasive procedure of liver biopsy with a biochemical diagnostic system that analyzes blood markers. This substitution eliminates the need for mechanical tissue extraction while maintaining diagnostic capability through chemical and biological marker analysis.
2Measurement precision
If liver biopsy is used for diagnosis, then diagnostic accuracy is improved, but cost increases
Solution Approach 1:
The patent provides a cost-effective diagnostic copy that replaces expensive biopsy procedures with affordable serum marker analysis. The panel of biochemical markers can be measured using standard laboratory techniques that are less costly than tissue biopsy processing, staining, and pathological review.
Solution Approach 2:
The patent uses inexpensive, readily available serum biochemical markers as disposable diagnostic elements instead of requiring expensive, complex biopsy procedures. These markers can be measured efficiently using standard laboratory assays that are more cost-effective than tissue processing and analysis.
3Ease of operation
If standard serum markers (AST/ALT ratio) are used, then ease of operation is improved, but diagnostic precision for ASH/NASH decreases
Solution Approach 1:
The patent merges multiple serum biochemical markers (ApoA1, ALT, AST, alpha-2-macroglobulin, GGT, total bilirubin, haptoglobin) into a comprehensive diagnostic panel that works together to provide precise diagnosis of ASH and NASH. This combination leverages the complementary information from each marker to achieve higher diagnostic precision than any single marker or simple ratio.
Solution Approach 2:
The patent creates a composite diagnostic system that integrates multiple biochemical markers into a unified diagnostic approach. This composite panel of markers provides comprehensive information about liver pathology, combining the strengths of each individual marker to achieve both ease of operation and high diagnostic precision.
Data Source
AI summary
The present invention is drawn to a new diagnosis method for detecting the extent of alcoholic or non-alcoholic steato-hepatitis in a patient, in particular in a patient suffering from a disease involving alcoholic or non-alcoholic steato-hepatitis or who already had a positive diagnosis test of liver fibrosis and/or presence of liver necroinflammatory lesions, by using the serum concentration of easily detectable biological markers. The invention is also drawn to diagnosis kits for the implementation of the method.