Acute Interstitial Nephritis Biomarker Panel for Non-Invasive Diagnosis

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Solution Overview

Problem

Current diagnostic methods for acute interstitial nephritis (AIN) are invasive, have low sensitivity and specificity, and rely heavily on clinical suspicion, lacking reliable non-invasive biomarkers for accurate diagnosis.

Innovation Solution

Development of a system using TNF-α, IL-9, and IL-5 as biomarkers in urine, saliva, or blood samples for diagnosing AIN, with a diagnostic index to differentiate AIN from other kidney diseases, and a point-of-care technology for rapid detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If kidney biopsy is performed to confirm AIN diagnosis, then diagnostic accuracy is improved, but patient risk of severe bleeding increases

Engineering Contradiction:

Improvediagnostic accuracyVSAvoidpatient risk of severe bleeding

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent introduces urinary biomarkers (eosinophil cationic protein, neutrophil elastase, and kidney injury molecule-1) as intermediary substances that indirectly indicate AIN diagnosis without requiring direct tissue sampling. These biomarkers serve as mediators between the disease state and diagnostic detection, eliminating the need for invasive kidney biopsy while maintaining diagnostic accuracy.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If current diagnostic tests (urine eosinophils, urine sediment examination, imaging tests) are used, then non-invasive diagnosis is achieved, but sensitivity and specificity are poor

Engineering Contradiction:

Improvenon-invasive diagnosisVSAvoidsensitivity and specificity

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent combines multiple biomarkers (eosinophil cationic protein, neutrophil elastase, and kidney injury molecule-1) into a composite diagnostic panel. This composite approach leverages the complementary information from different biomarker sources to achieve high sensitivity and specificity while maintaining non-invasive urine-based testing.

Inventive Principle:

Principle #40Composite materials

3Device complexity

If clinical suspicion alone is used to diagnose AIN, then diagnostic process is simplified, but reliability of diagnosis is reduced

Engineering Contradiction:

Improvediagnostic process complexityVSAvoidreliability of diagnosis

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The diagnostic system enables self-service through automated detection of biomarker levels in urine samples. The system objectively measures biomarker concentrations and compares them against established thresholds, eliminating subjective clinical judgment while maintaining diagnostic simplicity. This automated approach enhances reliability without significantly increasing procedural complexity.

Inventive Principle:

Principle #25Self-service

Data Source

PatentUS20250327815A1System and methods for diagnosing acute interstitial nephritis

Publication Date: 2025.10.23 PREDICT AIN LLC

AI summary

The invention provides methods and systems for detecting a biomarker related to AIN in a biological sample, and use thereof alone or as part of a diagnostic index for identifying and treating subjects at risk of AIN.