Laboratory Control Scheduling for Assay Integrity and Cost Reduction

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Solution Overview

Problem

Existing laboratory systems struggle to efficiently and cost-effectively manage the handling of positive and negative controls, which are essential for verifying assay and reagent integrity, due to the high expense of these controls and the need to run them frequently.

Innovation Solution

A laboratory system with a control unit and storage unit that optimizes controls handling by determining the appropriate control types and allocation rules for each assay type, allowing for flexible scheduling based on time or run rules, and ensuring that controls are run at the right frequency to maintain assay integrity while minimizing costs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If controls are run frequently to verify assay and reagent integrity, then reliability is improved, but cost increases

Engineering Contradiction:

Improveassay integrity verificationVSAvoidcost of controls

Core Design Contradiction:

ReliabilityVSQuantity of substance

Solution Approach 1:

The system dynamically adjusts control frequency based on multiple factors including assay type, reagent stability, historical performance data, and risk assessment. Allocation rules allow flexible scheduling where controls can be run more frequently for high-risk assays and less frequently for stable, low-risk assays, optimizing both reliability and cost-effectiveness

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system changes the parameter of control frequency based on assay characteristics, reagent lots, and performance thresholds. By adjusting these parameters dynamically rather than using fixed intervals, the system achieves reliable verification while minimizing control consumption and cost

Inventive Principle:

Principle #35Parameter changes

2Measurement precision

If controls are run separately from samples, then measurement precision is improved, but productivity decreases

Engineering Contradiction:

Improvecontrol result accuracyVSAvoidthroughput of tests

Core Design Contradiction:

Measurement precisionVSProductivity

Solution Approach 1:

The system merges control runs with sample runs by integrating controls into multiwell plate layouts. Controls and samples are processed together in the same run on the same device, maintaining the independence needed for accurate control results while significantly improving throughput by eliminating separate control processing steps

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The control system is designed to handle multiple functions simultaneously: processing samples, running controls, validating reagents, and verifying assay performance all in a single integrated workflow. This multi-functionality allows controls to be embedded within sample runs without compromising their independent verification capability

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Reliability

If positive controls are used to check assay functionality, then reliability is improved, but cost increases

Engineering Contradiction:

Improveassay functionality verificationVSAvoidexpense of positive controls

Core Design Contradiction:

ReliabilityVSQuantity of substance

Solution Approach 1:

The system applies partial action by running positive controls selectively rather than with every assay. Based on risk assessment, reagent stability, and assay criticality, the system determines when positive controls are necessary, running them at optimized frequencies that ensure reliability while minimizing the consumption of expensive positive control materials

Inventive Principle:

Principle #16Partial or excessive action

4Reliability

If control frequency is increased to detect contamination, then reliability is improved, but loss of time increases

Engineering Contradiction:

Improvecontamination detectionVSAvoidtime for control runs

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The system implements periodic control running based on defined allocation rules and time intervals. Rather than continuous control monitoring, the system schedules controls at optimal periodic intervals based on assay type, reagent stability, and risk factors, achieving effective contamination detection while minimizing time loss through strategic timing of control runs

Inventive Principle:

Principle #19Periodic action

Data Source

PatentUS20250027962A1Laboratory system with increased controls handling and method for increasing controls handling in a laboratory system or device

Publication Date: 2025.01.23 ROCHE MOLECULAR SYSTEMS INC

AI summary

A laboratory system or device comprising a control unit for controlling operation of the system or device, and a storage unit connected to the control unit and containing instruction for each assay type of the control type to be used when running said assay type, and, for each control type, an allocation rule for the control type. The control unit receiving at least one assay order comprising instructions to run at least one assay type on the system or device, determining for the at least one assay type comprised in the at least one assay order, the control type to be used, and the corresponding allocation rule for said control type, scheduling an assay run comprising instructions to include the determined control type based on the determined allocation rule, and controlling the system or device to perform the scheduled assay run.