Consumable Data Management for Automated Assay Reproducibility

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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 software architecture to minimize errors, ensure reproducibility, and calibrate pipettors and plate washers, using data deployable bundles for consumable data management and specialized lids to prevent reagent evaporation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If automated assay systems are used to improve productivity, then output per unit time increases, but human or machine errors during preparation, loading, and execution cause variability in reproducibility

Engineering Contradiction:
Improveoutput per unit timeVSAvoidreproducibility
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The system performs preliminary actions by pre-configuring consumable data in data deployable bundles, pre-validating assay protocols, and pre-calibrating instruments before actual assay execution. This ensures that all parameters are optimized and verified in advance, reducing errors during high-speed automated operation and improving reproducibility without sacrificing productivity

Inventive Principle:
Principle #10Preliminary action

2Measurement precision

If precision training plates and calibrated instruments are used to improve measurement precision, then assay accuracy improves, but device complexity increases

Engineering Contradiction:
Improveassay accuracyVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system uses disposable precision training plates and single-use calibrated consumables that are pre-manufactured to high precision specifications. These disposable components eliminate the need for complex recalibration mechanisms and repeated validation procedures, maintaining high measurement precision while reducing overall system complexity through standardized, replaceable parts

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Reliability

If specialized consumable storage units and standardized loading procedures are implemented to improve reliability, then loading errors are minimized, but ease of operation decreases

Engineering Contradiction:
Improveloading accuracyVSAvoiduser convenience
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The system implements self-service through automated consumable identification using data deployable bundles, automatic validation of consumable compatibility, and self-calibrating instruments. The system autonomously verifies loading accuracy and detects errors without requiring extensive user intervention or expertise, thereby maintaining high reliability while preserving ease of operation through automated quality control

Inventive Principle:
Principle #25Self-service

4Reliability

If tight timing tolerances and automated timing control are applied to ensure run-to-run reproducibility, then assay consistency improves, but productivity decreases due to extended validation time

Engineering Contradiction:
Improverun-to-run consistencyVSAvoidthroughput
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The system performs timing calibration and validation in advance using precision training plates and pre-configured protocols. By establishing timing parameters beforehand and storing them in data deployable bundles, the system eliminates the need for extended validation during each assay run, maintaining tight timing tolerances for consistency while preserving high throughput through pre-optimized parameters

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

The system achieves reproducible assay runs with minimized errors, maintains sample concentration consistency, and reduces background noise in ECL readings, ensuring consistent 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

Implementation Method 2

Specialized lids are provided to minimize the loss of reagents from container through evaporation

Methodology Applied
Scientific EffectEvaporation prevention: Evaporation

Implementation Method 3

electrochemiluminescent (ECL) immunoassays

Methodology Applied
Scientific EffectElectrochemiluminescence: Electrochemiluminescence

Data Source

PatentUS11119111B2Integrated consumable data management system and platform
Publication Date: 2021.09.14 MESO SCALE TECH LLC
  • US11119111B2 patent drawing
  • US11119111B2 patent drawing
  • US11119111B2 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.