Home-Based COVID-19 Lateral Flow Assay with Antigen-Releasing Buffer

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Solution Overview

Problem

Conventional rapid antigen tests for COVID-19 face challenges in accurately detecting viral antigens in complex biological samples like sputum due to masking or hiding of antigenic sites by mucus and biofilms, leading to false negative results.

Innovation Solution

An improved extraction buffer system containing detergents and digestive enzymes is used to lyse and disrupt viral membranes and biofilms, followed by a lateral flow immunoassay to enhance antigen detection in sputum samples.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional rapid antigen tests are used to detect viral antigens in sputum samples, then the test can be performed quickly and easily, but the detection sensitivity is reduced due to masking of antigenic sites by mucus and biofilms

Engineering Contradiction:
Improvetest simplicityVSAvoiddetection sensitivity
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent applies preliminary action by adding digestive enzymes (proteases, lipases, nucleases) and detergents to the sputum sample before the immunoassay test. This pre-treatment step breaks down mucus, biofilms, and viral envelopes in advance, exposing hidden antigenic sites before the antigen-antibody reaction occurs, thereby improving detection sensitivity without complicating the overall test procedure

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses digestive enzymes and detergents as intermediary substances that mediate between the masked viral antigens and the detection antibodies. These intermediaries break down the masking structures (mucus, biofilms, envelopes) to allow the antibodies to access and bind to the antigenic sites, resolving the contradiction between simple testing and sensitive detection

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If digestive enzymes and detergents are added to disrupt biofilms and mucus, then antigenic sites become more visible, but the device complexity increases

Engineering Contradiction:
Improveantigen visibilityVSAvoidextraction buffer composition
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent applies universality by designing a multi-functional extraction buffer that combines digestive enzymes (proteases, lipases, nucleases), detergents, and other agents into a single solution. This universal buffer performs multiple functions simultaneously: breaking down mucus, disrupting biofilms, dissolving viral envelopes, and exposing antigens, thereby improving antigen visibility without requiring multiple separate treatment steps or complex device modifications

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

Solution Approach 2:

The patent merges multiple functional components (digestive enzymes, detergents, buffer agents) into a single integrated extraction buffer system. This combination approach consolidates what would otherwise require multiple separate treatment steps into one unified solution, reducing device complexity while maintaining high antigen detection capability

Inventive Principle:
Principle #5Merging (Combining)

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 method increases the visibility of antigen-antibody complexes, reducing false negatives and improving the sensitivity of rapid antigen tests for COVID-19 diagnosis.

Implementation Method 1

An improved extraction buffer system containing one or more detergents or surfactants is used to lyse and disrupt membranes, envelopes, biofilms, or coating surfaces surrounding the virus

Methodology Applied
Scientific EffectLysis:

Implementation Method 2

one or more digestive enzymes, capable of lysing and disrupting membranes, envelopes, biofilms, or coating surfaces surrounding the virus and to extract and cleave proteins and other cellular or viral components

Methodology Applied
Scientific EffectProteolysis: Enzyme

Implementation Method 3

a lateral flow immunoassay to enhance antigen detection in sputum samples

Methodology Applied
Scientific EffectImmunoassay binding:

Data Source

PatentUS12416633B2Method and system for exposing hidden or masked antigenic sites of viral specimens present in biosamples using a home-based COVID-19 rapid lateral flow immunoassay test
Publication Date: 2025.09.16 PRINCETON BIOCHEMICALS INC
  • US12416633B2 patent drawing
  • US12416633B2 patent drawing
  • US12416633B2 patent drawing

AI summary

A disease detection system including a platform or cartridge to perform testing using a rapid lateral flow chromatographic immunoassay (LFIA) test intended for the qualitative detection of the disease in a sample, such as collected sputum, disrupted by a digestive enzyme and a detergent to release its content and digest its proteins and other polymeric molecules. A method of the present invention includes treating a sample with a digestive enzyme and a detergent to disrupt the collected sample releasing content and digesting proteins of the sample to form a lysed-digested-extracted sample, applying the lysed-digested-extracted sample to a platform or cartridge, performing a rapid lateral flow chromatographic immunoassay (LFIA) test of the lysed-digested-extracted sample using the platform or cartridge and detecting presence or absence of an analyte of interest from the tested lysed-digested-extracted sample.