Lateral Flow Device with Fc-Binding Protein for Universal SARS-CoV-2 Antibody Detection

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Solution Overview

Problem

Current diagnostic tests require separate kits for humans and animals to detect SARS-CoV-2 antibodies, which is inconvenient and does not allow for immediate informed treatment decisions, especially in cases of animal infections that can spread the virus to humans or other animals.

Innovation Solution

A lateral flow device that detects antibodies to SARS-CoV-2 using a strip with a sample pad, a conjugate pad containing recombinant SARS-CoV-2 spike protein antigen conjugated to a detection agent, and a detection band with an Fc-binding protein, enabling capillary flow and visual indication of antibody presence in both human and animal samples.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If separate diagnostic kits are used for humans and animals to detect SARS-CoV-2 antibodies, then detection accuracy for each species is maintained, but device complexity and operational convenience deteriorate due to requiring multiple different kits

Engineering Contradiction:
Improvedetection accuracyVSAvoidkit variety
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The lateral flow device uses an Fc-binding protein detection band that can bind to the Fc region of antibodies from both human and animal sources, allowing a single device to universally detect SARS-CoV-2 antibodies across multiple species without requiring species-specific kits

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If separate diagnostic kits are used for humans and animals, then species-specific detection requirements are met, but ease of operation deteriorates due to managing multiple different testing protocols

Engineering Contradiction:
Improvespecies-specific detectionVSAvoidtesting convenience
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The device provides a unified testing platform that operates with the same procedure for both human and animal samples, using the Fc-binding protein to detect antibodies from different species through a single lateral flow mechanism, thereby improving ease of operation while maintaining species-specific detection capability

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Loss of time

If rapid point-of-care detection is implemented, then immediate treatment decisions can be made, but manufacturing precision requirements increase to ensure reliable rapid results

Engineering Contradiction:
Improvedetection timeVSAvoidtest reliability
Core Design Contradiction:
Loss of timeVSManufacturing precision

Solution Approach 1:

The Fc-binding protein acts as an intermediary that rapidly captures antibody-antigen complexes at the detection band, enabling quick visual results while maintaining reliability through the high-affinity binding interaction between the Fc-binding protein and antibody Fc regions

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

Enables rapid, point-of-care detection of SARS-CoV-2 antibodies in both humans and animals, facilitating immediate treatment decisions and potentially limiting virus spread by providing a unified testing solution for both species.

Implementation Method 1

a strip formed of a material enabling capillary flow of fluid along a length of the strip

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

a detection band comprising an Fc-binding protein immobilized within the strip... when the mobilized spike protein conjugate in the sample contacts the Fc-binding protein in the detection band the presence of the antibodies to the SARS-CoV-2 virus in the sample is indicated by a visible color change

Methodology Applied
Scientific EffectImmunoglobulin binding: Adsorption

Data Source

PatentUS12169200B2Lateral flow device for detecting SARS-CoV-2 antibodies in human and animal samples
Publication Date: 2024.12.17 ZOETIS SERVICES LLC
  • US12169200B2 patent drawing
  • US12169200B2 patent drawing
  • US12169200B2 patent drawing

AI summary

The invention provides a lateral flow device and methods for the detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in a sample of bodily fluid of an animal or human. The test methods include contacting the sample with a conjugate comprising a recombinant SARS-CoV-2 spike protein antigen that has been conjugated to a detection agent, wherein an antigen-antibody complex is formed between the SARS-CoV-2 spike protein antigen conjugate and SARS-CoV-2 antibodies present in the sample; capturing the formed antigen-antibody complex with an Fc-binding molecule; and detecting the captured complex.