Polymeric Bead Analog Codes for Multiplex Assay Precision

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Solution Overview

Problem

Current multiplex assays are cumbersome and require large sample volumes, especially when analyzing multiple targets, and lack precision and reproducibility, as well as the ability to store information unrelated to the assay.

Innovation Solution

The use of polymeric beads with unique analog code identifiers, where each bead has a transparent and non-transparent polymer layer with a two-dimensional shape representing an analog code, allowing for precise identification and binding analysis of analytes, and additional beads for information storage such as manufacturing lot or location identifiers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If multiple singleplex assays are performed in parallel or sequential reaction vessels, then each target can be analyzed separately, but the sample volume required increases and the procedure becomes cumbersome

Engineering Contradiction:
Improveassay precisionVSAvoidsample volume
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The patent combines multiple singleplex assays into a single multiplex assay by using bead-coded identification systems. Each bead type is coded with a unique identifier that corresponds to a specific analyte, allowing multiple targets to be measured simultaneously in one reaction vessel. This merging approach reduces the number of reaction vessels needed and decreases the total sample volume required while maintaining assay precision through the bead-based identification and detection system.

Inventive Principle:
Principle #5Merging (Combining)

2Productivity

If traditional bead-based multiplex assays are used with fluorescence-based identification, then multiple analytes can be detected simultaneously, but the system complexity increases and additional identification systems are required

Engineering Contradiction:
Improveassay throughputVSAvoididentification system complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent extracts the identification function from complex fluorescence-based systems and implements it through simpler bead-coded identification. Instead of using multiple fluorophores and complex optical detection systems, the invention uses beads with embedded codes that can be identified through simpler means. This extraction of the identification function reduces system complexity while maintaining the ability to detect multiple analytes simultaneously, thereby improving assay throughput without proportionally increasing device complexity.

Inventive Principle:
Principle #2Taking out (Extraction)

3Productivity

If bead-based multiplex assays are implemented, then assay throughput increases and reagent cost decreases, but the requirement for precise bead identification and data management increases

Engineering Contradiction:
Improveassay throughputVSAvoidbead identification difficulty
Core Design Contradiction:
ProductivityVSDifficulty of detecting and measuring

Solution Approach 1:

The patent applies preliminary action by pre-coding beads with unique identifiers before the assay is performed. This pre-encoding of bead identities allows for automated identification and tracking throughout the multiplex assay process. The preliminary coding step simplifies subsequent detection and data management, as the bead identities are already established and can be read through the imaging system without requiring complex real-time identification during the assay, thereby reducing the difficulty of bead identification while maintaining high throughput.

Inventive Principle:
Principle #10Preliminary action

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 high-throughput, precise, and reproducible multiplex assays with reduced sample volume requirements, allowing for efficient data storage and calibration, thereby improving assay efficiency and accuracy.

Implementation Method 1

analog code identifiers, which are imaged and decoded by an imaging processor

Methodology Applied
Scientific EffectImage processing: Image Processing

Implementation Method 2

each bead of the plurality of beads comprises a capture agent that specifically binds to an analyte

Methodology Applied
Scientific EffectSpecific binding: Adsorption

Data Source

PatentUS11796535B2Methods and systems for multiplex assays
Publication Date: 2023.10.24 PLEXBIO
  • US11796535B2 patent drawing
  • US11796535B2 patent drawing
  • US11796535B2 patent drawing

AI summary

Disclosed herein are compositions comprising beads with unique analog code identifiers for storing information about a multiplex assay as well as methods for using the same in multiplex chemical and biological assays.