US2023278036A1PendingUtilityA1

System and method for processing and detecting nucleic acids

Assignee: NEUMODX MOLECULAR INCPriority: Feb 13, 2012Filed: May 15, 2023Published: Sep 7, 2023
Est. expiryFeb 13, 2032(~5.6 yrs left)· nominal 20-yr term from priority
B01L 3/502761B01L 7/525B01L 3/502738B01L 3/50851G01N 35/0098B01L 7/52C12Q 1/686B01L 2400/0622B01L 2400/0481B01L 3/50855B01L 2300/044B01L 2300/0627B01L 2300/168B01L 2400/0633B01L 2400/043B01L 2200/0668B01L 2300/0681B01L 2300/1822B01L 2400/0487B01L 2400/0655B01L 2200/10B01L 2200/0684B01L 2200/0689B01L 2300/0816B01L 2300/0867B01L 2300/087B01L 2300/0887B01L 2300/1827B01L 2400/0406B01L 2400/0694G01N 35/1016G01N 35/1079
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Claims

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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for processing and detecting nucleic acids from a sample with a cartridge comprising a fluidic pathway positioned relative to a heating region of the cartridge, wherein the method comprises:
 delivering the cartridge to a cartridge location of a molecular diagnostic module comprising one or more heaters, the molecular diagnostic module cooperating with a fluid handling subsystem comprising an actuator and an aspiration and delivery head coupled to the actuator, and a reagent receptacle comprising one or more storage containers for reagents; and   positioning the first surface of the cartridge relative to at least one of the one or more heaters;   executing a reagent receiving mode with movement of the aspiration and delivery head of the fluid handling system into fluid contact with at least one storage container; and   executing a reagent delivery mode with movement of the aspiration and delivery head of the fluid handling system into contact with a port of the cartridge.   
     
     
         2 . The method of  claim 1 , further comprising: executing an inventory management operation involving movement of one or more of: the cartridge and the one or more reagents. 
     
     
         3 . The method of  claim 1 , further comprising:
 with the fluid handling system, combining the sample with a quantity of magnetic beads to produce a nucleic acid-magnetic bead sample;   with the fluid handling system, transferring the nucleic acid-magnetic bead sample to the fluidic pathway of the cartridge; and   transmitting heat through a magnet housing region of the cartridge, by way of a magnet heating element coupled to a magnet, thereby facilitating release of nucleic acids from particles with magnetic functionality in the fluidic pathway of the cartridge.   
     
     
         4 . The method of  claim 1 , further comprising: automatically re-running a sample of the set of samples in response to return of a result matching predefined criteria by the processor. 
     
     
         5 . A method for processing and detecting nucleic acids from a sample with one or more cartridges comprising a fluidic pathway, wherein the method comprises:
 receiving the cartridge at a cartridge location within a molecular diagnostic module cooperating with a fluid handling subsystem comprising an actuator and an aspiration and delivery head coupled to the actuator, and a reagent receptacle comprising one or more storage containers for a set of reagents stored in an ambient condition; and   executing a reagent receiving mode with movement of the aspiration and delivery head of the fluid handling system into fluid contact with at least one of the one or more storage containers; and   executing a reagent delivery mode with movement of the aspiration and delivery head of the fluid handling system into contact with a port of the cartridge.   
     
     
         6 . The method of  claim 5 , wherein the set of reagents is cooled to a temperature below the ambient condition. 
     
     
         7 . A method for processing samples, wherein the method comprises:
 receiving one or more containers at a sample processing system comprising a reagent receptacle comprising one or more storage containers for a set of reagents stored in an ambient condition, a fluid handling subsystem comprising an actuator and an aspiration and delivery head coupled to the actuator, and a molecular diagnostic module;   transferring, using the fluid handling subsystem, material of one or more of the one or more containers to the molecular diagnostic module for processing;   in coordination with transferring material of one of the one or more containers to the molecular diagnostic module:
 executing a reagent receiving mode with movement of the aspiration and delivery head of the fluid handling system into fluid contact with at least one of the one or more storage containers; and 
 executing a reagent delivery mode with movement of the aspiration and delivery head of the fluid handling system into communication with the molecular diagnostic module. 
   
     
     
         8 . The method of  claim 7 , wherein one or more containers comprises primary collection tubes. 
     
     
         9 . The method of  claim 7 , wherein the one or more containers and the set of reagents are each produced using batch production processes and each contain more than one unitized reaction and are configured to be implemented in a unitized operation.

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