Urine Exosome Biomarker Detection for Hepatitis Diagnosis

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current diagnostic tests for hepatitis virus infections and diseases are not reliable, rapid, cost-effective, and invasive, particularly lacking effective methods for detecting viral antigens or antibodies in urine.

Innovation Solution

A method involving the preparation of exosomes from bodily fluids, specifically urine, followed by contacting them with hepatitis virus-associated biomarker binding agents and detection reagents to determine the presence of hepatitis virus biomarkers, indicating infection or disease conditions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If serum or plasma is used for hepatitis virus detection, then detection sensitivity is improved, but invasiveness increases and patient comfort deteriorates

Engineering Contradiction:

Improvedetection sensitivityVSAvoidinvasiveness

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent uses exosomes as an intermediary carrier to transfer viral biomarkers from infected cells into the urine. By detecting these exosome-associated viral antigens or antibodies in urine, the method achieves high detection sensitivity without requiring invasive blood sampling. The exosomes act as a mediator that bridges the gap between the viral infection site and the non-invasive urine sample.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If Western blot procedure is used to confirm viral infection, then diagnostic reliability is improved, but time consumption and complexity increase

Engineering Contradiction:

Improvediagnostic reliabilityVSAvoidtime consumption

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent segments the diagnostic process into two independent detection steps: initial screening using exosome-based urine tests for viral antigens/antibodies, followed by confirmation using standard Western blot only when needed. This segmentation allows most cases to be resolved rapidly through the exosome test, while maintaining diagnostic reliability through selective use of Western blot for confirmatory testing.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The exosome-based urine test serves as a preliminary screening tool that can rapidly identify potential hepatitis virus infections before committing to time-consuming Western blot procedures. This preliminary action filters out negative cases quickly, reserving the more complex confirmation tests only for ambiguous or positive cases that require further verification.

Inventive Principle:

Principle #10Preliminary action

3Measurement precision

If RT-PCR is used to detect viral RNA, then detection precision is improved, but cost and technical complexity increase

Engineering Contradiction:

Improvedetection precisionVSAvoidtechnical complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent employs disposable exosome-based diagnostic test strips or kits that can be used once and discarded, eliminating the need for expensive, complex RT-PCR equipment and specialized laboratory infrastructure. These disposable test elements provide sufficient detection precision for hepatitis virus diagnosis while being far simpler and more cost-effective than molecular biology methods.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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

Provides a reliable, rapid, and less invasive diagnostic method for hepatitis virus infections and diseases, enabling effective detection of hepatitis virus biomarkers in urine samples.

Implementation Method 1

Exosomes are small vesicles 40-100 nm in diameter, that are secreted by a number of different cell types for communicating with other cells via the proteins and ribonucleic acids they carry

Methodology Applied

Scientific EffectExosomal transport:

Implementation Method 2

contacting said exosome preparation with one or more hepatitis virus-associated biomarker binding agents selective for a hepatitis virus

Methodology Applied

Scientific EffectAntigen-antibody binding:

Data Source

PatentUS12517129B2Exosome-mediated diagnosis of hepatitis virus infections and diseases

Publication Date: 2026.01.06 MOREHOUSE SCHOOL OF MEDICINE

AI summary

A method for diagnosing hepatitis virus infection or a hepatitis disease condition in a subject based on hepatitis virus-associated biomarkers present on exosomes in a bodily fluid sample from the subject is disclosed. Also disclosed are a method for monitoring the course of a hepatitis virus infection or a hepatitis disease condition in a subject and a method for monitoring effectiveness of treatment to a subject with an anti-hepatitis virus agent based on hepatitis virus-associated biomarkers present on exosomes in bodily fluid samples from the subject, as well as a kit for diagnosing hepatitis virus infection and/or a hepatitis disease condition in a subject based on hepatitis virus-associated biomarkers on exosomes in bodily fluid samples from the subject.