Albumin Binding Capacity Test Strips for Rapid Functional Assessment

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Solution Overview

Problem

Current methods for determining albumin binding capacity are complex and time-consuming, requiring laboratory analysis, which hinders point-of-care diagnostics and individualized treatment planning for patients with impaired albumin function due to liver or kidney failure.

Innovation Solution

A method involving the use of albumin-binding markers such as benzodiazepine, tryptophan, bile acids, and others, to form complexes with albumin, followed by separation and detection using test strips to determine the relative binding capacity of albumin, allowing for rapid assessment of albumin function.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If laboratory analysis methods are used to determine albumin binding capacity, then measurement precision is improved, but time consumption and device complexity increase

Engineering Contradiction:
Improvealbumin binding capacity measurement precisionVSAvoidtime consumption for analysis
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent extracts the essential measurement function from complex laboratory analysis by using a specific binding marker (diazepam) that selectively binds to albumin. The method isolates the binding capacity assessment from other interfering substances through selective marker binding, allowing rapid measurement without full laboratory analysis infrastructure.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces a binding marker (diazepam) as an intermediary substance that mediates between the albumin sample and the measurement system. The marker binds to albumin with known characteristics, creating a measurable complex that reflects albumin binding capacity while enabling use of simpler detection methods like test strips or fluorescence readers.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If complex laboratory analysis is used, then measurement precision is improved, but ease of operation deteriorates

Engineering Contradiction:
Improvealbumin binding capacity measurement precisionVSAvoidease of operation for point-of-care diagnostics
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent employs disposable test strips or single-use measurement cuvettes that can be discarded after one use. These disposable elements contain pre-coated antibodies or binding reagents, eliminating the need for complex preparation, cleaning, and calibration procedures required by reusable laboratory equipment, thus dramatically improving ease of operation at point-of-care settings.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent replaces complex mechanical laboratory analysis systems with simpler optical or chemical detection methods. Instead of requiring sophisticated chromatography or electrophoresis equipment, the invention uses fluorescence detection, colorimetric test strips, or other simplified readout systems that can be operated by non-specialists in clinical settings.

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

3Productivity

If rapid test strips are used, then productivity is improved, but measurement precision may deteriorate

Engineering Contradiction:
Improvespeed of albumin binding capacity determinationVSAvoidaccuracy of binding capacity measurement
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent performs preliminary preparation of the measurement system during manufacturing of the test strip or reagent kit. Antibodies, binding markers, or detection reagents are pre-coated, pre-mixed, or pre-calibrated in controlled conditions. This preliminary action ensures that the rapid point-of-care test maintains measurement precision comparable to laboratory methods while achieving fast results.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent optimizes parameters such as marker concentration, incubation time, and detection sensitivity to achieve the best balance between speed and precision. By carefully controlling these parameters - for example, using fluorescence intensity thresholds or colorimetric endpoint detection - the method maintains accurate measurement of albumin binding capacity while enabling results in minutes rather than hours.

Inventive Principle:
Principle #35Parameter changes

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 fast and simple determination of albumin binding capacity at the point of care, facilitating individualized treatment planning and reducing the risk of overtreatment or undertreatment by considering the patient's current condition.

Implementation Method 1

the at least one albumin-binding marker M in at least one measurement solution of the test sample and the reference sample exceeds the presumed binding capacity of the albumin

Methodology Applied
Scientific EffectBinding: Absorption (physical)

Implementation Method 2

Separating the complexes (M:A) generated in step b)

Methodology Applied
Scientific EffectSeparation: Centrifugal Separation

Data Source

PatentEP3612842B1Methods for determining the relative binding capacity of albumin
Publication Date: 2025.11.26 FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV
  • EP3612842B1 patent drawingFigure 1
  • EP3612842B1 patent drawingFigure 2
  • EP3612842B1 patent drawingFigure 3A~3B

AI summary

The invention relates to methods for determining the relative binding capacity of albumin by means of test strips. In particular, the invention relates to a method for determining the relative binding capacity of albumin comprising the following steps: a) providing at least two measurement solutions of a test sample and of a reference sample, the measurement solutions containing at least one albumin-binding marker M and said at least one albumin-binding marker M exceeding the presumably present binding capacity of albumin in at least one measurement solution of the test sample and of the reference sample and the test sample having a certain amount of albumin having unknown binding capacity and the reference sample having the same certain amount of albumin having a reference binding capacity; b) incubating the measurement solutions under conditions that allow the at least one albumin-binding marker M to bind to albumin such that complexes of said marker M and albumin (M:A) arise; c) removing the complexes (M:A) produced in step b); d) detecting the presence or the amount of unbound marker M in the solutions after the removal of the complex (M:A) by means of at least one test strip, which allows the unbound marker to be determined; and e) determining the relative binding capacity of albumin in the test sample on the basis of the presence or the detected amounts of unbound marker M in step d). The invention further relates to a method for determining the amount of functional albumin.