Random-Access Nucleic Acid Amplification for Mixed IVD and LDT Assays
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Solution Overview
Problem
Existing analytical systems are limited to performing molecular assays in batch mode, requiring separate runs for in-vitro diagnostic (IVD) and lab-developed tests (LDTs, without the ability to perform them simultaneously or in random access mode, necessitating reagent and consumable changes between assay types.
Innovation Solution
An automated system and method for performing nucleic acid amplification assays that allow simultaneous execution of IVD and LDT assays on the same or different samples, using system-defined and user-defined parameters, with independent thermal profiles and reagent handling to form and process amplification reaction mixtures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If batch mode operation is used to perform molecular assays, then the system can complete one assay type before initiating another, but the system cannot perform IVD and LDT assays simultaneously and requires pausing for reagent changes between assay types
Solution Approach 1:
The system divides the assay execution into separate modular workflows - IVD assay workflow and LDT assay workflow - that can be independently configured and executed. Each workflow has its own reagent loading and processing steps, allowing parallel execution without interference. The controller manages these segmented workflows separately, enabling simultaneous operation of different assay types on the same or different samples.
Solution Approach 2:
The analytical system is designed with universal reagent handling capabilities that can accommodate both IVD and LDT assay requirements through a single integrated platform. The system uses universal sample receptacles, universal reagent storage, and a universal control architecture that can execute different assay protocols without requiring separate dedicated systems. This multi-functionality eliminates the need to pause for reagent changes between assay types.
2Reliability
If the system is designed to perform only IVD assays with system-defined parameters, then the operation is simplified and reliable, but the system lacks flexibility to accommodate user-defined LDT assays
Solution Approach 1:
The control system dynamically adapts its operation mode based on the assay type being executed. For IVD assays, the system operates in a constrained mode with fixed system-defined parameters to ensure reliability and consistency. For LDT assays, the system transitions to a flexible mode that accepts user-defined parameters while maintaining core process control. This dynamic adjustment of system behavior allows the platform to provide both reliability for routine assays and flexibility for customized assays.
Solution Approach 2:
The system applies different levels of parameter control specificity to different assay types. IVD assays utilize system-wide standardized parameters for consistency, while LDT assays allow user-specific parameter customization at the local assay level. The controller intelligently determines which parameter set to apply based on the selected assay type, ensuring that each assay receives the appropriate level of flexibility or standardization.
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 simultaneous and flexible performance of multiple nucleic acid amplification assays without pausing for reagent changes, supporting both IVD and LDT assays in a random access manner, enhancing efficiency and flexibility 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.) 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.