System and method for processing and detecting nucleic acids

Inventors

Williams, JeffreyBrahmasandra, SundareshMastronardi, Michelle

Assignees

NeumoDx Molecular Inc

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Publication Number

US-11648561-B2

Patent

Publication Date

2023-05-16

Expiration Date


Abstract

A system and method for processing and detecting nucleic acids from a set of biological samples, comprising: a capture plate and a capture plate module configured to facilitate binding of nucleic acids within the set of biological samples to magnetic beads; a molecular diagnostic module configured to receive nucleic acids bound to magnetic beads, isolate nucleic acids, and analyze nucleic acids, comprising a cartridge receiving module, a heating/cooling subsystem and a magnet configured to facilitate isolation of nucleic acids, a valve actuation subsystem configured to control fluid flow through a microfluidic cartridge for processing nucleic acids, and an optical subsystem for analysis of nucleic acids; a fluid handling system configured to deliver samples and reagents to components of the system to facilitate molecular diagnostic protocols; and an assay strip configured to combine nucleic acid samples with molecular diagnostic reagents for analysis of nucleic acids.

Core Innovation

The invention describes an integrated nucleic-acid molecular diagnostic system that cooperates with a cartridge having a heating region defined at a first surface. The heating region spans a set of microfluidic pathways of the cartridge, and the microfluidic pathways perform amplification and detection of nucleic acid content. The system includes a molecular diagnostic module and one or more cartridge heaters operable to transmit heat to the heating region at the first surface.

The molecular diagnostic module receives the cartridge at a cartridge platform and positions the first surface of the cartridge relative to the one or more cartridge heaters. The system also includes a reagent receptacle with one or more storage containers for one or more reagents, and a fluid handling subsystem comprising an actuator and an aspiration and delivery head coupled to the actuator. The processors execute instructions to receive the cartridge, perform a reagent receiving mode by moving the aspiration and delivery head into fluid contact with at least one storage container, and perform a reagent delivery mode by moving the aspiration and delivery head into contact with a port of the cartridge.

After reagent delivery, the processors perform amplification and detection of one or more nucleic acids by way of the set of microfluidic pathways. The integrated design further describes automation features including a cartridge heater and a microfluidic pathway-based processing stage, together with optical LED/filter/photodetector detection to generate quantitative/qualitative data. The described workflow also includes using a disposable capture plate with magnetic beads, DNA/RNA sample process controls, and an assay strip that unitizes amplification/detection reagents and mixes with nucleic acids for delivery to detection chambers.

Claims Coverage

The independent claims explicitly require a molecular diagnostic system that receives and heats a cartridge with microfluidic amplification and detection pathways, uses a fluid handling subsystem to receive and deliver reagents from a reagent receptacle to the cartridge, and performs amplification and detection of nucleic acids under processor-executed instructions. The excerpted independent claim set includes independent claim clm-00001; other listed claim identifiers are referenced as refinements rather than independent claims in the provided text.

Cartridge heating region spanning microfluidic amplification and detection pathways

The system cooperates with a cartridge having a heating region defined at a first surface, where the heating region spans a set of microfluidic pathways for performing amplification and detection of nucleic acid content.

Molecular diagnostic module with cartridge receiver and cartridge heaters

The system includes a molecular diagnostic module with a cartridge receiver comprising a cartridge platform and one or more cartridge heaters operable to transmit heat to the heating region at the first surface.

Reagent receptacle and fluid handling subsystem for reagent receiving and delivery

The system includes a reagent receptacle with one or more storage containers for one or more reagents, and a fluid handling subsystem comprising an actuator and an aspiration and delivery head coupled to the actuator.

Processor-executed cartridge positioning and amplification/detection workflow

One or more processors execute instructions to receive the cartridge at the cartridge platform, position the first surface of the cartridge relative to the one or more cartridge heaters, execute a reagent receiving mode by movement of the aspiration and delivery head into fluid contact with at least one storage container, execute a reagent delivery mode by movement of the aspiration and delivery head into contact with a port of the cartridge, and perform amplification and detection of one or more nucleic acids.

In the provided excerpt, the claim coverage centers on a processor-controlled system that integrates cartridge heating over a microfluidic heating region for amplification and detection, together with reagent receiving and delivery using an aspiration and delivery head into cartridge ports, and execution of amplification and detection of nucleic acids through the cartridge microfluidic pathways.

Stated Advantages

Documented Applications

No documented applications found

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