SARS-CoV-2 Antigen Lateral Flow Immunoassay

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Solution Overview

Problem

Current methods for detecting SARS-CoV-2 antigens lack specificity and sensitivity, particularly in identifying the presence and quantity of the virus in human samples, which is crucial for managing COVID-19 transmission effectively.

Innovation Solution

The development of a method using a pair of antibodies specifically designed to bind to the SARS-CoV-2 nucleocapsid protein, employing an immunoassay such as ELISA or lateral flow immunoassay, where the first antibody binds to the protein and a second antibody with a detectable label indicates the presence of the virus, enhancing detection specificity and lowering the limit of detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current detection methods are used, then detection can be performed, but specificity and sensitivity are insufficient

Engineering Contradiction:
Improvedetection specificity and sensitivityVSAvoidcross-reactivity with other pathogens
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent employs a pair of antibodies that recognize distinct epitopes on the SARS-CoV-2 nucleocapsid protein. This segmentation of recognition targets allows the detection system to specifically identify SARS-CoV-2 while minimizing cross-reactivity with other pathogens, thereby improving both measurement precision and reliability

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent optimizes multiple parameters including antibody concentration ratios, incubation conditions, and detectable label characteristics to enhance detection sensitivity and specificity. By carefully adjusting these parameters, the assay achieves lower limits of detection while maintaining high reliability

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If antibody-based immunoassay is used, then detection specificity is improved, but detection limit sensitivity must be enhanced

Engineering Contradiction:
Improveantigen identification accuracyVSAvoidlimit of detection
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The patent uses a sandwich immunoassay format where the first antibody binds to the nucleocapsid protein, and the second antibody binds to a different epitope on the same protein. This nested arrangement of antibodies around the antigen creates a stable complex that amplifies the detectable signal, thereby enhancing sensitivity while maintaining specificity

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent introduces a detectable label as an intermediary component attached to the second antibody. This mediator converts the specific antibody-antigen binding event into a measurable signal, significantly enhancing the limit of detection while preserving the specificity provided by the antibody pair

Inventive Principle:
Principle #24Intermediary (Mediator)

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 improves the specificity and sensitivity of SARS-CoV-2 detection, allowing for accurate identification of the virus in various sample types, including nasal swabs and saliva, with minimal cross-reactivity and interference from other pathogens or substances.

Implementation Method 1

contacting a sample obtained from a subject with a first antibody or antigen-binding fragment thereof which specifically binds to a protein from the SARS-CoV-2 virus

Methodology Applied
Scientific EffectAntibody-antigen binding:

Implementation Method 2

contacting the sample with a conjugate comprising a second antibody which specifically binds to the protein from the SARS-CoV-2 virus, and a detectable label

Methodology Applied
Scientific EffectAntibody-antigen binding:

Implementation Method 3

assessing the presence of a signal from the detectable label, wherein the presence of a signal from the detectable label indicates the presence of the protein from the SARS-CoV-2 virus

Methodology Applied
Scientific EffectDetectable label signal:

Data Source

PatentUS20240345088A1Antigen lateral flow
Publication Date: 2024.10.17 ABBOTT RAPID DIAGNOSTICS INT UNLTD
  • US20240345088A1 patent drawing

AI summary

The present disclosure relates to methods of detecting a protein from the SARS-CoV-2 virus, or a fragment thereof, in a sample obtained from a subject using a first antibody or antigen-binding fragment thereof that binds to a protein from the SARS-CoV-2 virus, or a fragment thereof, and a second antibody or antigen-binding fragment thereof which binds to a protein from the SARS-CoV-2 virus, or a fragment thereof.