Non-Invasive Serum Marker Tests for NASH and NAFLD Diagnosis
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current non-invasive quantitative tests for detecting non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are inadequate as they fail to accurately identify patients with liver inflammation or significant NAFLD disease, particularly those without steatosis.
Innovation Solution
Development of two new non-invasive tests: the Metabolic-NASH-ActiTest, a quantitative test that assesses necroinflammatory histological activity, and the Metabolic-FibroActiTest, a binary test that predicts significant NAFLD disease. These tests utilize a combination of biochemical markers, excluding BMI and fasting glucose, and are designed to detect patients with significant liver disease without requiring the presence of steatosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If liver biopsy is performed to accurately detect NASH and significant fibrosis, then diagnostic precision is improved, but patient safety and ease of operation deteriorate due to invasive nature and limited applicability to large populations
Solution Approach 1:
The patent replaces the mechanical invasive procedure of liver biopsy with a non-invasive biochemical test system. The test uses serum markers (alpha2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT, fasting glucose, triglycerides, cholesterol, ALT, and AST) combined with patient demographics to predict NASH and significant fibrosis without physical tissue sampling, thereby maintaining diagnostic precision while dramatically improving ease of operation and patient safety
Solution Approach 2:
The patent introduces serum biochemical markers as intermediary substances that reflect liver pathology without requiring direct tissue access. These markers serve as mediators between the liver disease state and the diagnostic test, allowing indirect but accurate measurement of NASH and fibrosis severity through blood analysis rather than direct biopsy
2Reliability
If liver biopsy is performed on large numbers of patients with metabolic risk factors, then detection coverage is improved, but patient safety deteriorates due to procedural risks
Solution Approach 1:
The patent replaces the harmful invasive biopsy procedure with a safe non-invasive blood test, allowing screening of large populations with metabolic risk factors without exposing patients to procedural risks such as bleeding, infection, or organ damage associated with liver biopsy
3Ease of operation
If current non-invasive tests (FibroTest, SteatoTest) are used to estimate liver fibrosis and steatosis, then ease of operation is improved, but measurement precision deteriorates because they cannot accurately identify NASH or significant disease without steatosis
Solution Approach 1:
The patent combines multiple serum biochemical markers (alpha2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT, fasting glucose, triglycerides, cholesterol, ALT, and AST) with patient demographic information into a composite diagnostic test system. This composite approach captures multiple aspects of liver pathology including inflammation, fibrosis, and metabolic dysfunction, achieving high precision in identifying NASH and significant disease regardless of steatosis presence while maintaining ease of operation through routine blood test components
4Measurement precision
If tests include BMI and fasting glucose to assess metabolic risk, then detection sensitivity for metabolic syndrome-related liver disease is improved, but device complexity and ease of operation worsen due to additional measurements and protocols
Solution Approach 1:
The patent merges BMI and fasting glucose measurements with the other serum biochemical markers into a single integrated diagnostic test system. By combining these metabolic risk indicators with liver function markers in one comprehensive test panel, the patent maintains high detection sensitivity for metabolic syndrome-related liver disease while minimizing additional complexity, as these measurements can be obtained through routine clinical procedures
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
The present invention relates to new methodsfor assessing NAFLD and NAH in a patient, combining measurement of serum markersthrough a logistic function.