Immunochromatographic Asthma Diagnostic Strip Using Monoclonal Antibodies

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Solution Overview

Problem

Current diagnostic methods for asthma and allergy diseases, particularly in infants and children, are cumbersome, invasive, and lack reliability, often misdiagnosing the cause of airway inflammation and requiring specialized equipment and skilled personnel, leading to inappropriate treatments.

Innovation Solution

A diagnostic kit utilizing a strip with monoclonal antibodies from a hybridoma cell line (Accession Number KCLRF-BP-00389) for rapid immunochromatographic testing of eosinophil-derived neurotoxin (EDN), allowing for quick and accurate diagnosis of asthma and allergy diseases through a simple, non-invasive method.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If pulmonary function test or methacholine bronchial challenge test is used for asthma diagnosis, then diagnostic accuracy is improved, but device complexity and ease of operation deteriorate due to requiring well-managed equipment and skilled testers

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidequipment complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The invention extracts the diagnostic function from complex hospital equipment and skilled operator dependency, concentrating it into a portable immunochromatographic strip that can be operated by anyone with minimal training. The strip contains pre-loaded reagents and antibodies, extracting the complexity from the testing process while maintaining diagnostic accuracy.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The immunochromatographic strip is designed to perform the diagnostic test automatically without requiring skilled operators. The sample application, reagent mixing, incubation, and result detection are all self-contained within the strip structure, eliminating the need for well-managed external equipment and skilled testers.

Inventive Principle:
Principle #25Self-service

2Measurement precision

If pulmonary function test or methacholine bronchial challenge test is used for asthma diagnosis, then diagnostic accuracy is improved, but ease of operation deteriorates due to requiring skilled testers and positive patient responses

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidtesting ease
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The invention removes the requirement for skilled testers by extracting the diagnostic capability into a simple immunochromatographic strip. The test can be performed by any caregiver or parent on infants and children without requiring professional training, dramatically improving ease of operation.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The strip performs the diagnostic function autonomously once the sample is applied. No skilled operation is needed as the immunochromatographic reaction proceeds automatically, and results are visually detectable without specialized equipment or interpretation skills.

Inventive Principle:
Principle #25Self-service

3Ease of operation

If eosinophil count or serum eosinophil cationic proteins is measured for asthma diagnosis, then noninvasive testing is achieved, but measurement precision deteriorates due to large individual differences

Engineering Contradiction:
Improvenoninvasive testingVSAvoiddiagnostic reliability
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The invention targets a specific local marker (EDN protein) rather than general eosinophil counts or cationic proteins. By focusing on eosinophil-derived neurotoxin specifically, the test achieves high diagnostic reliability for asthma while maintaining the noninvasive nature of blood or sputum sampling, overcoming the individual variation problem of broader markers.

Inventive Principle:
Principle #3Local quality

4Loss of time

If rapid immunochromatographic method is used for diagnosis, then diagnosis time is reduced, but measurement precision may deteriorate compared to traditional laboratory methods

Engineering Contradiction:
Improvediagnosis timeVSAvoiddiagnostic reliability
Core Design Contradiction:
Loss of timeVSMeasurement precision

Solution Approach 1:

The invention extracts the essential diagnostic function into a rapid immunochromatographic format that delivers results in minutes rather than hours or days. The strip contains optimized reagent concentrations and reaction conditions that maintain high measurement precision despite the shortened time frame, overcoming the traditional trade-off between speed and accuracy.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The immunochromatographic method uses optimized parameters including antibody concentrations, buffer compositions, and reaction temperatures that enable rapid detection without sacrificing precision. The visual colorimetric readout and controlled reaction conditions ensure reliable results are achieved within minutes, resolving the contradiction between speed and accuracy.

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

The kit enables rapid, reliable diagnosis of asthma and allergy diseases, improving treatment accuracy and prognosis monitoring by detecting EDN levels with high specificity and sensitivity, outperforming traditional methods like eosinophil cationic proteins and other diagnostic kits.

Implementation Method 1

a first reaction part formed on the base part and including a monoclonal antibody expressed from a hybridoma cell line (Accession Number KCLRF-BP-00389)

Methodology Applied
Scientific EffectAntigen-antibody binding:

Implementation Method 2

a developing membrane formed between the first reaction part and the base part and including a second reaction part

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS11009506B2Kit for rapid diagnosis of asthma or allergy disease
Publication Date: 2021.05.18 INJE UNIVERSITY INDUSTRY ACADEMIC COOPERATION FOUNDATION
  • US11009506B2 patent drawing
  • US11009506B2 patent drawing
  • US11009506B2 patent drawing

AI summary

Provided is a kit for asthma diagnosis comprising a strip including a base part, a first reaction part formed on the base part, and a developing membrane formed between the first reaction part and the base part, in which the first reaction part includes a monoclonal antibody expressed from a hybridoma cell line of Accession Number KCLRF-BP-00389 (Accession Date: Jan. 9, 2017, Accession Institute: Korea Cell Line Research Foundation (KCLRF)) and the second reaction part includes a monoclonal antibody expressed from a hybridoma cell line of Accession Number KCLRF-BP-00389 (Accession Date: Jan. 9, 2017, Accession Institute: Korea Cell Line Research Foundation (KCLRF)).