Variant-Specific ELISA Screening With Vero E6 Parameters

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Solution Overview

Problem

Existing ELISA processes for screening SARS-CoV-2 variants are unpredictable due to virus mutations, leading to inconsistent results with different starting materials, making it impractical to determine effective combinations of dilutions, cell lines, and virus titers without significant time and resource expenditure.

Innovation Solution

Specific workable ranges for starting materials and incubation periods are established for different SARS-CoV-2 variants, including the Washington strain, Alpha, Gamma P.1, Beta, Iota, Delta, Omicron BA.1, Omicron BA.5, and Omicron XBB.1.5 variants, using Vero E6 and modified Vero E6-TMPRSS2/ACE2 cells, to quantify neutralizing antibodies effectively.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional ELISA processes are used for screening SARS-CoV-2 variants, then the general screening function is maintained, but the results become unpredictable and inconsistent due to virus mutations

Engineering Contradiction:
Improvepredictability of screening resultsVSAvoidadaptability to different virus variants
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent applies parameter changes by establishing specific workable ranges for starting materials and incubation periods tailored to different SARS-CoV-2 variants. Each variant (Washington, Alpha, Gamma P.1, Beta, Iota, Delta, Omicron BA.1, BA.5, XBB.1.5) has optimized parameters including starting dilutions, cell lines, and incubation times. This resolves the contradiction by making the ELISA process adaptable to variant changes while maintaining reliable, predictable results through standardized parameter ranges.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If standard ELISA procedures are applied without variant-specific optimization, then the screening process remains simple, but significant time and resources are expended to characterize starting materials for each new variant

Engineering Contradiction:
Improvespeed of variant characterizationVSAvoidtime to determine effective combinations
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The patent applies preliminary action by pre-establishing workable parameter ranges for multiple SARS-CoV-2 variants before they emerge in the field. The methodology provides ready-to-use starting dilutions, cell line selections, and incubation periods for various variants, eliminating the need for time-consuming characterization when new variants appear. This resolves the contradiction by enabling rapid deployment of optimized screening protocols without requiring extensive new experimentation.

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If extensive experimentation is conducted to find effective starting materials for each variant, then accurate parameters can be determined, but the process becomes impractical and resource-intensive

Engineering Contradiction:
Improveaccuracy of assay parametersVSAvoidcomplexity of screening process
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent applies universality by creating a multi-functional screening system that handles multiple SARS-CoV-2 variants through a unified methodology. The same ELISA platform with standardized procedures can screen Washington, Alpha, Gamma P.1, Beta, Iota, Delta, and Omicron variants by simply adjusting pre-determined parameters. This resolves the contradiction by maintaining accurate, variant-optimized parameters while keeping the overall process simple and manageable through a universal approach.

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

Data Source

PatentUS20250283881A1SYSTEMS AND PROCESSES TO SCREEN FOR SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-CoV-2) OF 2019 (COVID-19)
Publication Date: 2025.09.11 BATTELLE MEMORIAL INST
  • US20250283881A1 patent drawing
  • US20250283881A1 patent drawing
  • US20250283881A1 patent drawing

AI summary

The present disclosure provides systems and processes to screen for SARS-CoV-2. This disclosure teaches specific (and different) workable ranges for starting materials in a screening process for different SARS-CoV-2 variants (e.g., the Washington isolate, Alpha variant, Gamma P.1 variant, Beta variant, Iota variant, Delta variant, Omicron BA.1 variants, etc.). As shown herein, each variant has a different combination of starting materials and incubation periods, which further demonstrates the unpredictability of success that is associated with the disclosed systems and the disclosed processes. To be clear, the general ELISA process is well known by those having skill in the art. However, what is neither well known nor intuitive are the specific parameters associated with different process steps within ELISA. Those specific parameters are the subject of this disclosure.