Immunoassay Probe Regeneration for Cost Reduction

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Solution Overview

Problem

Current immunoassay technologies face challenges in reducing costs while maintaining clinical performance, particularly in serial measurements for cardiac markers, where cost limitations restrict appropriate testing.

Innovation Solution

A method that reuses immunoassay test probes and reagents multiple times by employing a denaturing reagent to regenerate the probe without affecting antibody binding, utilizing a fluorescent detection system with a small probe tip to minimize reagent consumption and enable multiple assay cycles without additional reagents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If immunoassay test probes and reagents are used once and discarded, then clinical assay performance is maintained, but cost per test is high

Engineering Contradiction:

Improveclinical assay performanceVSAvoidcost per test

Core Design Contradiction:

ReliabilityVSLoss of substance

Solution Approach 1:

The patent applies the discarding and recovering principle by implementing a probe regeneration system. After use, probes are treated with denaturing reagents to strip bound analytes and reagents, then rinsed and stored for reuse. This allows the same probe to be used multiple times (at least 20 cycles) while maintaining assay performance, directly reducing material consumption and cost per test.

Inventive Principle:

Principle #34Discarding and recovering

2Loss of substance

If probes are reused multiple times, then cost per test is reduced, but probe functionality may deteriorate

Engineering Contradiction:

Improvecost per testVSAvoidprobe functionality

Core Design Contradiction:

Loss of substanceVSReliability

Solution Approach 1:

The patent employs parameter changes by carefully controlling the chemical environment during probe regeneration. Specific pH ranges, temperatures, and reagent concentrations are used to denature bound analytes without damaging the probe's functional components. This allows the probe to be chemically reset for reuse while preserving its binding and detection capabilities across multiple cycles.

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

This approach significantly reduces costs per test while maintaining clinical assay performance, allowing for 3 to 20 times reuse of probes and reagents, facilitating efficient and cost-effective serial measurements.

Implementation Method 1

employing a denaturing reagent to regenerate the probe without affecting antibody binding

Methodology Applied

Scientific EffectDenaturation:

Implementation Method 2

utilizing a fluorescent detection system with a small probe tip

Methodology Applied

Scientific EffectFluorescence: Fluorescence

Data Source

PatentEP3295174B1Method for re-using test probe and reagents in an immunoassay

Publication Date: 2020.11.04 ACCESS MEDICAL SYSTEMS LTD

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AI summary

The present invention is directed an immunoassay method, which re-uses an antibody-immobilized test probe and reagents for quantitating an analyte in different samples, anywhere from about 3 to 20 times, while maintaining acceptable clinical assay performance. The method regenerates the test probe after completion of each cycle of reaction. The present invention is also directed to a unitized cartridge (a strip) for an immunoassay test. Each unitized cartridge contains all necessary reagents can be used for 3-20 cycles to measure 3-20 different samples.