Automated Nucleic Acid Assays With Random Access Parameter Control
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Solution Overview
Problem
Existing analytical systems are limited to performing molecular assays in batch mode, requiring separate processing of IVD and LDT assays without the ability to perform them simultaneously or in random order, necessitating reagent and consumable changes between assay types.
Innovation Solution
An automated analyzer capable of performing multiple nucleic acid amplification assays with system-defined and user-defined parameters, allowing simultaneous execution of IVD and LDT assays on the same or different samples using shared modules and random access mode, with features like magnetic solid supports, fluid transfer, and real-time detection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If batch mode processing is used for molecular assays, then assay completion is ensured, but system downtime increases and productivity decreases
Solution Approach 1:
The system dynamically switches between batch mode and random access mode based on assay requirements. The automated analyzer can pause batch processing to accommodate random access requests, and vice versa, allowing flexible adaptation to different operational scenarios without compromising either reliability or productivity
Solution Approach 2:
The system implements periodic reagent replacement cycles within batch mode processing. Reagents are automatically replaced at predetermined intervals during batch processing, enabling continuous operation without complete system downtime while maintaining assay completion reliability
2Reliability
If separate processing of IVD and LDT assays is performed, then assay specificity is maintained, but operational complexity increases and time loss occurs
Solution Approach 1:
The automated analyzer is designed with universal reagent storage and delivery systems that can accommodate both IVD and LDT assay requirements. The system uses universal reaction vessels and detection mechanisms that work with different assay types, eliminating the need for separate processing while maintaining assay specificity through software-controlled parameter differentiation
Solution Approach 2:
The system introduces an automated reagent management system as an intermediary between reagent storage and assay processing. This intermediary automatically tracks reagent types, volumes, and compatibility, enabling seamless transitions between IVD and LDT assays without manual intervention or time-consuming reagent changes
3Adaptability or versatility
If random access mode is implemented, then operational flexibility increases and productivity improves, but system complexity increases
Solution Approach 1:
The system segments control functions into modular software components that manage different access modes independently. The random access controller, batch mode controller, reagent management module, and detection module operate as separate but coordinated units, reducing overall system complexity through functional segmentation while maintaining operational flexibility
Solution Approach 2:
The automated analyzer implements self-service through automated sample tracking, reagent management, and assay parameter selection. The system automatically identifies samples, selects appropriate assays based on pre-programmed protocols, and adjusts processing parameters without user intervention, reducing the complexity burden on operators while maintaining high adaptability
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
Enables flexible and efficient performance of multiple nucleic acid amplification assays with reduced downtime, supporting both IVD and LDT assays concurrently and in any order, enhancing operational flexibility and throughput.
Implementation Method 1
The automated system may include one or more wash stations configured to expose a first sample to reagents and conditions sufficient to immobilize a first analyte on a first magnetic solid support
Implementation Method 2
PCR employs thermal cycling, which consists of repeated cycles of heating and cooling of a reaction mixture
Implementation Method 3
The growth of the amplicon may be detected using signal detecting devices (e.g., fluorescence detection devices) that measure signal emissions (e.g., level of fluorescence at a predetermined wavelength or range of wavelengths, etc.) indicative of the amplicon
Data Source
Figure 1A
Figure 1B
Figure 2A
AI summary
Systems and methods for performing a plurality of nucleic acid amplification assays in an automated analyzer. A first nucleic acid amplification assay of the plurality is performed in accordance with a first set of assay parameters which consist of system-defined parameters. And a second nucleic acid amplification assay of the plurality is performed in accordance with a second set of assay parameters which includes one or more user-defined parameters.