SARS-CoV-2 Immune Competence Assessment via S1/RBD Antibody Regression

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Solution Overview

Problem

Current methods for determining immune competence against SARS-CoV-2 are time-consuming, dangerous, and unable to accurately assess the ability to neutralize the virus, as they rely on detecting binding antibodies rather than neutralizing antibodies.

Innovation Solution

A method involving the detection of binding antibodies against SARS-CoV-2 spike subunit 1 (S1) protein and receptor binding domain (RBD) protein, using a regression model to calculate a weighted value that correlates with immune competence, allowing for the determination of neutralizing antibody titer.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If virus neutralization test is used to detect neutralizing antibody titer, then immune competence can be accurately evaluated, but the test requires virus cultivation which is dangerous and time-consuming

Engineering Contradiction:
Improveimmune competence evaluation accuracyVSAvoidtest duration
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent uses binding antibody levels as a surrogate copy/indicator to estimate neutralizing antibody titers. Instead of directly measuring neutralizing antibodies through virus neutralization tests, the method measures binding antibodies against SARS-CoV-2 proteins (S1 and RBD) and uses regression models to predict neutralizing antibody levels. This copying approach eliminates the need for actual virus cultivation while providing accurate immune competence evaluation.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent introduces binding antibodies as an intermediary measurement. Rather than directly assessing neutralizing antibodies through complex virus neutralization assays, the method uses binding antibodies against S1 and RBD proteins as intermediate markers that correlate with neutralizing antibody levels. Regression models establish the relationship between these intermediary measurements and actual immune competence, simplifying the evaluation process.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If virus neutralization test is used to detect neutralizing antibody titer, then immune competence can be accurately evaluated, but virus cultivation is required which poses safety risks

Engineering Contradiction:
Improveneutralizing antibody detection accuracyVSAvoidsafety risks from virus cultivation
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the essential measurement function from the dangerous virus cultivation process. By measuring binding antibodies against purified SARS-CoV-2 proteins (S1 and RBD) instead of requiring live virus cultivation, the method separates the diagnostic function from the hazardous viral material. This extraction eliminates safety risks while preserving the ability to evaluate immune competence through correlated measurements.

Inventive Principle:
Principle #2Taking out (Extraction)

3Ease of operation

If binding antibody detection kits are used, then detection can be performed quickly and safely, but the kits cannot determine whether a subject has immune competence against SARS-CoV-2

Engineering Contradiction:
Improvedetection convenience and safetyVSAvoidimmune competence assessment capability
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent implements a feedback mechanism where binding antibody levels against S1 and RBD proteins are measured, then fed into regression models that predict neutralizing antibody titers. This feedback loop transforms simple binding antibody measurements into comprehensive immune competence assessments. The models continuously refine the estimation of neutralizing antibody levels based on the measured binding antibody concentrations, enabling accurate immune competence determination through convenient binding antibody detection.

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS12467926B2Method for determining immune competence against severe acute respiratory syndrome coronavirus 2
Publication Date: 2025.11.11 CHANG GUNG UNIVERSITY
  • US12467926B2 patent drawing

AI summary

A method for determining immune competence against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) includes obtaining a blood sample from a subject in need thereof, detecting, in the blood sample, levels of binding antibodies against SARS-CoV-2 spike S1 protein and its receptor binding domain (RBD), and calculating a weighted value using a regression model. Another method for determining immune competence against SARS-CoV-2 is also disclosed.