Urinary ApoA1 Measurement for Early Nephropathy Risk Diagnosis

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Solution Overview

Problem

Current methods fail to effectively diagnose the risk of progression to nephropathy in diabetes patients at the pre-nephropathy stage, limiting early intervention and increasing future medical burdens and expenses.

Innovation Solution

A method involving the measurement of apolipoprotein A1 (ApoA1) concentration in urine using a capturing body, such as an anti-ApoA1 antibody, to determine the risk of progression to nephropathy by comparing the concentration to a predetermined threshold value, with a reagent kit comprising specific capturing and detecting bodies and a label substance for accurate detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional diagnostic methods (GFR measurement, urine albumin measurement) are used, then current diagnostic capabilities are maintained, but the ability to diagnose risk of progression to nephropathy in pre-nephropathy patients is insufficient

Engineering Contradiction:
Improvediagnostic precision for progression riskVSAvoidreliability of early progression risk diagnosis
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The invention changes the diagnostic parameter from conventional markers (GFR, urine albumin) to apolipoprotein A1 concentration in urine, which provides superior precision for predicting nephropathy progression in pre-nephropathy patients. This parameter change enables early identification of high-risk patients before significant kidney function decline occurs.

Inventive Principle:
Principle #35Parameter changes

2Loss of time

If early diagnosis of progression risk is achieved, then timely intervention can be provided, but current methods fail to provide sufficient diagnostic capability for this purpose

Engineering Contradiction:
Improvetime for early interventionVSAvoidprecision of progression risk assessment
Core Design Contradiction:
Loss of timeVSMeasurement precision

Solution Approach 1:

The invention enables preliminary identification of patients at risk of nephropathy progression by measuring apolipoprotein A1 in urine during the pre-nephropathy stage. This preliminary diagnostic action allows clinicians to initiate preventive treatments before the disease progresses to incipient or overt nephropathy, thereby reducing future medical burdens.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If dialysis treatment is required due to disease progression, then life-sustaining treatment is provided, but the burden on patient and medical expenses increase significantly

Engineering Contradiction:
Improvelife-sustaining treatment assuranceVSAvoidmedical expenses and patient burden
Core Design Contradiction:
ReliabilityVSLoss of energy

Solution Approach 1:

The invention applies preliminary anti-action by identifying high-risk patients through apolipoprotein A1 measurement and initiating preventive treatments during the pre-nephropathy stage. This counteracts the disease progression before it reaches the dialysis stage, thereby preventing the harmful outcome of end-stage renal disease while avoiding the substantial medical expenses and patient burden associated with long-term dialysis.

Inventive Principle:
Principle #9Preliminary anti-action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables early identification of patients at high or low risk of progressing to nephropathy, allowing for timely intervention and reducing the likelihood of disease progression and associated medical costs.

Implementation Method 1

measuring a concentration of ApoA1 in urine of a diabetes patient who is at pre-nephropathy

Methodology Applied
Scientific EffectAntibody-antigen binding:

Implementation Method 2

a reagent kit comprising specific capturing and detecting bodies and a label substance for accurate detection

Methodology Applied
Scientific EffectImmunoassay detection:

Data Source

PatentEP3225996B1Method for assisting diagnosis of risk of progression to nephropathy and use of reagent kit
Publication Date: 2019.07.10 SYSMEX CORP
  • EP3225996B1 patent drawingFigure 1
  • EP3225996B1 patent drawingFigure 2
  • EP3225996B1 patent drawingFigure 3A

AI summary

Disclosed is a method for assisting a diagnosis of a risk of progression to nephropathy, the method including the steps of: measuring a concentration of apolipoprotein A1 (ApoA1) in urine of a diabetes patient who is at pre-nephropathy; and determining that the patient is at a high risk of progression to nephropathy when a value of the concentration of ApoA1 in urine is equal to or higher than a predetermined threshold value or determining that the patient is at a low risk of progression to nephropathy when the value of the concentration of ApoA1 in urine is lower than the predetermined threshold value.