Automated Nucleic Acid Assays for Mixed IVD and LDT Processing
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Solution Overview
Problem
Existing analytical systems are limited to performing molecular assays in batch mode, requiring separate setups for IVD and LDT assays, and cannot handle mixed or interleaved sample processing efficiently.
Innovation Solution
An automated analyzer system that allows simultaneous performance of IVD and LDT assays on a single platform by using system-defined and user-defined parameters for nucleic acid amplification, with separate reaction mixtures and thermal conditions for each assay, and real-time detection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If batch mode operation is used for molecular assays, then assay reliability is maintained through dedicated setups, but system versatility and productivity deteriorate due to inability to perform multiple assay types simultaneously
Solution Approach 1:
The analytical system is designed to perform multiple types of molecular assays (IVD assays and LDTs) on the same platform using a universal reaction chamber and shared modules. The system accepts different assay types and configurations without requiring separate dedicated systems, enabling IVD and LDT assays to be performed simultaneously or in any order on the same instrument.
Solution Approach 2:
The system allows dynamic reconfiguration of assay parameters and protocols through programmable control. Different thermal profiles, cycling conditions, and detection parameters can be dynamically adjusted between and during assays. The random access capability allows the system to dynamically switch between different assay types based on sample loading and reagent availability, rather than following a fixed batch sequence.
2Productivity
If separate batch processing is used for different assay types, then assay specificity is maintained, but productivity and throughput deteriorate due to sequential processing requirements
Solution Approach 1:
The system enables continuous operation by allowing multiple assay types to run simultaneously in the same reaction chamber without pausing for reagent changes. IVD assays and LDTs can be performed in an interleaved or random order, eliminating idle time between different assay types. The random access capability ensures that the system can continuously process samples regardless of assay type or sample arrival order.
Solution Approach 2:
The system merges previously separate IVD and LDT assay workflows into a single integrated platform. Both assay types share common modules including the reaction chamber, thermal cycling system, and detection systems. This consolidation eliminates the need for separate dedicated systems and reduces overall processing time by allowing parallel execution of different assay types.
3Reliability
If dedicated systems are used for each assay type, then assay reliability is improved, but device complexity and cost increase
Solution Approach 1:
A single analytical system is designed to reliably perform multiple assay types (IVD and LDT) through programmable control and configurable parameters. The system maintains assay-specific reliability by allowing different thermal profiles, cycling conditions, and detection parameters for each assay type while using the same physical platform, eliminating the need for multiple dedicated systems.
Solution Approach 2:
The system segments different assay protocols and parameters into separate programmable configurations that can be independently controlled. Each assay type has its own set of optimized parameters (thermal profiles, cycling conditions, detection settings) that are maintained separately in the system's memory and applied as needed, ensuring assay-specific reliability while sharing common hardware resources.
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, efficient, and simultaneous processing of multiple nucleic acid amplification assays without the need for intermediate reagent changes, improving throughput and versatility in molecular diagnostics.
Implementation Method 1
PCR employs thermal cycling, which consists of repeated cycles of heating and cooling of a reaction mixture
Implementation Method 2
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.)
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.