Automated Multi-Assay Processing With Lockstep Timing
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Solution Overview
Problem
Clinical laboratories face challenges in efficiently processing a diverse range of nucleic acid amplification-based tests due to the need for unique assay protocols for each test type, leading to increased scheduler complexity and resource inefficiencies in instruments that process multiple assays simultaneously.
Innovation Solution
An automated system for multi-assay processing that uses a lockstep protocol with equal time periods for sample preparation, processing, and analysis steps across different assays, incorporating a sample processing unit (SPU) cartridge and optical detection with regular intervals for data collection, to harmonize the processing of multiple assays.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If unique assay protocols are developed for each type of assay to optimize assay performance, then assay performance is improved, but scheduler complexity and resource inefficiencies increase
Solution Approach 1:
The patent implements a universal assay protocol that can be applied across multiple different assay types simultaneously. The system uses a common set of reagents, processing steps, and time parameters that work for diverse nucleic acid amplification assays, allowing the automated instrument to process multiple assay types with a single standardized protocol rather than requiring unique protocols for each assay.
Solution Approach 2:
The system employs a combinatorial approach where a limited set of standardized protocol parameters (reagents, steps, times, temperatures) are systematically combined to accommodate different assay requirements. By changing and recombining these standardized parameters, the system optimizes performance for multiple assay types without creating entirely separate protocols for each one.
2Productivity
If multiple assay types are processed simultaneously per run, then system throughput is improved, but scheduler complexity increases significantly
Solution Approach 1:
The universal protocol enables the scheduler to handle multiple assay types using the same processing framework, reducing the complexity of coordinating different assay requirements. The standardized structure allows the scheduling system to efficiently allocate resources and coordinate simultaneous processing without managing entirely separate protocol sets for each assay type.
3Reliability
If unique assay protocols with varying reagents, steps and times are used, then assay optimization is improved, but efficient use of system resources is reduced
Solution Approach 1:
The standardized protocol uses a universal set of reagents and processing steps that can be applied across multiple assay types, improving system resource efficiency by reducing the variety and quantity of different reagents needed. The system maintains assay optimization by allowing flexible combination of these standardized components rather than requiring completely unique protocols for each assay.
Solution Approach 2:
The system optimizes resource efficiency by standardizing protocol parameters that can be systematically varied and recombined. This approach reduces waste from specialized reagents and processing steps while maintaining the ability to optimize each assay type through parameter adjustment within the standardized framework.
Data Source
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AI summary
The instant disclosure provides methods of multi-assay processing and multi-assay analysis. Such multi-assay processing and analysis pertain to automated detection of target nucleic acids, e.g., as performed in the clinical setting for diagnostic purposes. Also provided are common assay timing protocols derived from a variety of individual nucleic acid amplification and analysis protocols and modified to prevent resource contention. The instant disclosure also provides systems and devices for practicing the methods as described herein.