Urine Biomarker Scoring for Early Kidney Transplant Rejection

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Solution Overview

Problem

Current methods for detecting transplant rejection, particularly kidney transplant rejection, rely on qualitative data with low sensitivity and high operator error, leading to late detection and ineffective treatment, increasing the risk of organ rejection and complications.

Innovation Solution

An automated system using a cartridge pre-loaded with antibodies for CXCL9, CXCL10, CCL2, and VEGF-A proteins to detect protein levels in urine samples, analyzing the data with a logistical regression model to provide a score for transplant rejection risk, and administering tailored immunosuppressive or rejection therapy based on specific protein thresholds.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If automated systems with multiple protein markers and logistical regression models are implemented, then measurement precision and detection accuracy improve, but device complexity increases

Engineering Contradiction:
Improvedetection accuracyVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system segments the rejection detection process into distinct functional modules: (1) a cartridge containing pre-loaded antibodies for capturing target proteins (CXCL9, CXCL10, CCL2, VEGF-A), (2) a detection system for measuring protein levels, and (3) a control system with processors that execute logistical regression models. This modular segmentation allows each component to be optimized independently while maintaining high overall detection accuracy through the integrated multi-marker approach.

Inventive Principle:
Principle #1Segmentation

2Ease of operation

If qualitative data with low sensitivity is used, then ease of operation is maintained, but measurement precision deteriorates

Engineering Contradiction:
Improveoperational simplicityVSAvoiddetection sensitivity
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The cartridge is pre-loaded with optimized antibodies and reagents, enabling the system to automatically perform complex multi-step protein detection without requiring manual intervention for each step. The automated system executes the complete workflow including sample processing, protein capture, detection, and data analysis, maintaining operational simplicity while achieving high measurement precision through quantitative multi-marker analysis with logistical regression modeling.

Inventive Principle:
Principle #25Self-service

3Device complexity

If operator-dependent methods are used, then device complexity is reduced, but reliability deteriorates due to high operator error

Engineering Contradiction:
Improvesystem simplicityVSAvoidoperator error rate
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The system replaces manual operator-dependent procedures with an automated mechanical and computational system. The control system with processors automatically executes logistical regression models to analyze protein level data and generate rejection risk scores, eliminating human subjectivity and error. This automation maintains manageable device complexity through modular design while significantly improving reliability by removing operator variability from the detection and interpretation process.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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

The system provides early and accurate detection of transplant rejection, reducing operator variability and enabling timely intervention, thereby improving patient outcomes and reducing organ rejection risks.

Implementation Method 1

contacting a urine sample with antibodies specific for each of the CXCL9, CXCL10, CCL2, and VEGF-A proteins; detecting the amount of each of CXCL9, CXCL10, CCL2, and VEGF-A bound to the antibodies

Methodology Applied
Scientific EffectAntibody-antigen binding:

Data Source

PatentUS20250377363A1Methods relating to diagnosing stability following renal transplantation
Publication Date: 2025.12.11 THE UAB RESEARCH FOUNDATION INC

AI summary

Clinical detection or diagnosis of transplant rejection currently utilizes various methods that rely on qualitative rather than quantitative data, or quantitative data that has low sensitivity and/or has a high rate of operator error. Provided herein are methods for identifying kidney transplant rejection in patents that is automated and consistent for the user. Further described herein are cut-offs for transplant biomarkers that relate to renal transplantation stability or rejection.