Consumable Data Management for Reproducible Automated Assays

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Solution Overview

Problem

Automated biological assays face challenges in reproducibility and repeatability due to human or machine errors during preparation, consumable loading, and execution, with issues like sample concentration variations, evaporation, and background noise in electrochemiluminescent (ECL) readings.

Innovation Solution

An automated assay system with precision training plates, heat exchangers, standardized consumable storage, and a user interface to guide loading, along with a data deployable bundle (DDB) for consumable data management, minimizes errors and ensures reproducibility by calibrating pipettors and plate washers, and using specialized lids to prevent reagent evaporation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual preparation and loading of consumables is performed, then flexibility in operation is maintained, but human errors occur leading to poor reproducibility and repeatability

Engineering Contradiction:
ImprovereproducibilityVSAvoidmanual operation
Core Design Contradiction:
ReliabilityVSExtent of automation

Solution Approach 1:

The system enables self-service through automated consumable identification and tracking. The assay system automatically reads consumable identifiers, retrieves associated data from storage, and uses this data to adjust operations without manual intervention, thereby improving reproducibility while maintaining operational flexibility

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system implements feedback mechanisms by continuously monitoring consumable data and using this information to adjust assay operations in real-time. The consumable data service processor queries the data registry and remote databases, then feeds this information back to the assay system to optimize performance and ensure reproducibility

Inventive Principle:
Principle #23Feedback

2Measurement precision

If consumable data is not tracked, then system complexity is reduced, but analytical parameters cannot be properly monitored leading to assay errors

Engineering Contradiction:
Improveanalytical parameter trackingVSAvoiddata management system
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The consumable data service processor acts as an intermediary between the assay system and the complex data management infrastructure. It handles queries to the data registry and remote consumable data databases, translating system needs into data retrieval operations and returning processed information, thereby enabling precise tracking without exposing system complexity

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system moves data management to another dimension by separating consumable data storage and processing from the core assay execution. The data registry and remote databases store analytical parameters in a dedicated data layer, allowing the assay system to access precise measurement data without the complexity of direct data management

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Reliability

If standardized consumable loading is implemented, then loading errors are minimized, but ease of operation is reduced

Engineering Contradiction:
Improveloading accuracyVSAvoidloading flexibility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The system performs self-service during consumable loading by automatically reading identifiers and verifying data. The assay system autonomously confirms proper consumable placement and retrieves associated data, ensuring loading accuracy while requiring minimal user intervention and maintaining operational simplicity

Inventive Principle:
Principle #25Self-service

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 system achieves reproducible assay runs with minimized errors, maintaining consistent sample concentrations and reducing background noise, ensuring accurate and reliable assay results.

Implementation Method 1

Heat exchangers are provided to maintain a selected operating temperature in the assay system

Methodology Applied
Scientific EffectHeat exchange: Heat Exchanger

Data Source

PatentUS11686739B2Integrated consumable data management system and platform
Publication Date: 2023.06.27 MESO SCALE TECH LLC
  • US11686739B2 patent drawing
  • US11686739B2 patent drawing
  • US11686739B2 patent drawing

AI summary

The present invention relates to methods, devices and systems for associating consumable data with an assay consumable used in a biological assay. Provided are assay systems and associated consumables, wherein the assay system adjusts one or more steps of an assay protocol based on consumable data specific for that consumable. Various types of consumable data are described, as well as methods of using such data in the conduct of an assay by an assay system. The present invention also relates to consumables (e.g., kits and reagent containers), software, data deployable bundles, computer-readable media, loading carts, instruments, systems, and methods, for performing automated biological assays.