Lateral Flow Antigen Testing With Enzymatic Sputum Pre-Treatment
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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, facilitating the exposure of hidden antigenic sites in sputum samples, enhancing the binding of antigens to antibodies in a lateral flow immunoassay.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional rapid antigen tests are used without sample pre-treatment, then the test procedure is simple and quick, but the detection sensitivity is reduced due to masking of antigenic sites by mucus and biofilms
Solution Approach 1:
The patent applies preliminary action by introducing a sample pre-treatment step that uses digestive enzymes (proteases, lipases, nucleases) and detergents to degrade mucus, biofilms, and viral envelopes before the antigen detection step. This pre-processing exposes hidden antigenic sites that would otherwise be masked, thereby improving detection sensitivity without significantly complicating the overall test procedure
Solution Approach 2:
The patent uses digestive enzymes and detergents as intermediary substances that mediate between the complex biological sample (sputum with mucus and biofilms) and the antigen detection system. These intermediaries break down the masking structures and release antigens, enabling the antibody-antigen binding to occur effectively
2Measurement precision
If sample pre-treatment with enzymes and detergents is applied, then detection sensitivity increases by exposing hidden antigens, but the test procedure time and complexity increase
Solution Approach 1:
The patent optimizes parameters such as enzyme concentration, detergent concentration, incubation temperature, and incubation time to achieve effective antigen exposure within a reasonable time frame. By carefully controlling these parameters, the method balances the need for thorough sample processing with the desire to minimize test duration
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 sensitivity of antigen detection, making previously undetectable antigenic sites visible, thereby reducing false negative results and improving the accuracy of 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
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
Implementation Method 3
facilitating the exposure of hidden antigenic sites in sputum samples, enhancing the binding of antigens to antibodies in a lateral flow immunoassay
Implementation Method 4
a method and system for detection of disease including analysis of antigenic reactive components of viral specimens obtained from biosamples against conjugated anti-SARS-COV-2 antibodies
Data Source
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.