Automated Assay Compatibility Index for Concurrent Molecular Diagnostics

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Solution Overview

Problem

Automated diagnostic instruments face challenges in performing multiple assays concurrently due to physical and regulatory incompatibilities, requiring manual comparison of assay protocols which is error-prone and labor-intensive.

Innovation Solution

The implementation of a system that assigns first- and second-level compatibility index values to assay protocols, allowing compatible protocols to be run concurrently while preventing incompatible ones, using Assay Definition Files (ADFs) and User Defined Protocols (UDPs) to manage compatibility and automate the assay process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual comparison of assay protocols is performed to determine compatibility, then compatibility assessment can be done, but it is error-prone and labor-intensive

Engineering Contradiction:
Improvecompatibility assessment accuracyVSAvoidoperational complexity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The system performs automatic compatibility assessment by comparing assay protocol parameters against predefined compatibility criteria, eliminating the need for manual comparison. The instrument autonomously determines whether multiple assays can be performed concurrently based on parameters such as reagent compatibility, temperature requirements, and workflow conflicts.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces the manual mechanical process of comparing assay protocols with an automated computational system. The instrument's software automatically retrieves assay parameters, compares them against compatibility rules, and determines compatibility status, substituting human operators with an automated information processing system.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Productivity

If multiple assays are performed concurrently to increase throughput, then productivity improves, but physical and regulatory incompatibilities may arise

Engineering Contradiction:
Improvetesting throughputVSAvoidassay compatibility
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The system performs compatibility assessment before scheduling concurrent assays. By evaluating assay parameters and checking for conflicts in advance, the instrument determines which assays can be safely performed together, preventing incompatibility issues before they occur.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system provides feedback on assay compatibility to guide run scheduling. When compatibility issues are detected, the system notifies users and adjusts the scheduling of concurrent assays to avoid conflicts, ensuring that only compatible assays are performed together.

Inventive Principle:
Principle #23Feedback

3Ease of operation

If automated assay processing is implemented to reduce manual labor, then ease of operation improves, but the complexity of managing multiple assay protocols increases

Engineering Contradiction:
Improveautomation levelVSAvoidprotocol management complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The instrument is designed with multi-functional capability to handle diverse assay protocols through a unified automated interface. The system can retrieve parameters from different assay types, apply universal compatibility criteria, and manage multiple protocols through a single automated workflow, reducing the complexity burden on users.

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

Data Source

PatentEP2810080B1External files for distribution of molecular diagnostic tests and determination of compatibility between tests
Publication Date: 2024.03.27 BECTON DICKINSON & CO
  • EP2810080B1 patent drawingFigure 1
  • EP2810080B1 patent drawingFigure 2
  • EP2810080B1 patent drawingFigure 3

AI summary

Embodiments disclosed herein relate to methods and systems for performing an automated assay, and particularly to performing an assay on a plurality of samples on an automated instrument.