High-throughput serology assay via microplate segmentation

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Solution Overview

Problem

Current serology assays face constraints in time, cost, and sample use when detecting viral antibodies in large numbers of patient samples, limiting their effectiveness in pandemic response efforts.

Innovation Solution

The method involves placing patient antibody content onto an assay surface and incubating it with a virus-specific antigen solution, allowing for the detection of bound antigens, which can be done in a multiplex format to achieve ultra-high throughput and reduce costs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If traditional serology assays are used to detect viral antibodies in large numbers of patient samples, then detection accuracy is maintained, but processing time and cost increase significantly

Engineering Contradiction:
Improveprocessing throughputVSAvoidassay processing time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The patent segments the assay process by placing individual patient samples in discrete wells of a microplate, allowing parallel processing of multiple samples simultaneously. Each well contains a specific patient sample and can be independently analyzed, enabling high-throughput screening without compromising detection accuracy.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs a universal assay platform that can detect antibodies against different viruses using the same basic methodology and reagents. The microplate format and antigen-coating process can be adapted to screen for multiple viral pathogens simultaneously, making the system versatile for various pandemic response scenarios.

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

2Productivity

If traditional serology assays are used to detect viral antibodies in large numbers of patient samples, then detection reliability is maintained, but cost increases significantly

Engineering Contradiction:
Improveprocessing throughputVSAvoidassay cost
Core Design Contradiction:
ProductivityVSEase of manufacture

Solution Approach 1:

The patent merges multiple detection functions into a single assay well by coating antigens directly onto the well surface and adding patient serum. This combination of sample preparation, antigen presentation, and antibody detection in one integrated process reduces reagent consumption and manual handling steps, thereby lowering per-sample costs while maintaining reliability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent uses identical assay protocols and reagent compositions replicated across numerous wells in a microplate. By copying the same validated assay design across 96 or 384 wells, the system achieves high throughput without requiring development of multiple different assays, reducing overall manufacturing complexity and cost.

Inventive Principle:
Principle #26Copying

3Measurement precision

If multiplexed immunoassays with fluorescent dyes are used, then detection sensitivity is improved, but assay complexity and cost increase

Engineering Contradiction:
Improvedetection sensitivityVSAvoidassay complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the detection function to a separate read step using standard plate readers or visual inspection. Instead of incorporating complex fluorescent labeling and detection systems into every assay step, the method separates the antigen-antibody binding event from the detection event, allowing simple, cost-effective readout methods to be used while maintaining sensitivity through optimized antigen coating and sample preparation.

Inventive Principle:
Principle #2Taking out (Extraction)

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

This approach enables the rapid and cost-effective processing of millions of patient samples, providing critical data for understanding COVID-19 prevalence and immunity, facilitating economic and societal reopening.

Implementation Method 1

applying an antigen-containing fluid to an assay surface, the antigen-containing fluid containing an antigen for the virus to be detected and the assay surface containing a biological sample from the individual

Methodology Applied
Scientific EffectAntigen-antibody binding:

Data Source

PatentUS20230314430A1High-throughput serology assay
Publication Date: 2023.10.05 INANOVATE INC

AI summary

The invention relates generally to serology assays and, more particularly, to high-throughput serology assays. One aspect of the invention provides a method of detecting a viral antibody in a biological sample of an individual, the method comprising: applying an antigen-containing fluid to an assay surface, the antigen-containing fluid containing an antigen for the vims to be detected and the assay surface containing a biological sample from the individual; removing the antigen-containing fluid from the assay surface; and determining whether the assay surface contains bound antigen.