Diagnostic system
Inventors
Andeshmand, Sayeed • Cauley, III, Thomas H. • Dixon, John • GLADE, David • Maamar, Hédia • McAdams, Michael John • Ng, Dzam-Si Jesse • Rolfe, David Alexander
Assignees
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Publication Number
US-11986299-B2
Publication Date
2024-05-21
Expiration Date
Abstract
Methods and systems are provided for point-of-care nucleic acid amplification and detection. One embodiment of the point-of-care molecular diagnostic system includes a cartridge and an instrument. The cartridge can accept a biological sample, such as a urine or blood sample. The cartridge, which can comprise one or more of a loading module, lysis module, purification module and amplification module, is inserted into the instrument which acts upon the cartridge to facilitate various sample processing steps that occur in order to perform a molecular diagnostic test.
Core Innovation
The integrated diagnostic cartridge integrates a loading module, a lysis module, a purification module, and a reaction module, and the modules are in fluidic communication so that sample processing proceeds from loading to lysis, from purification to reaction within a single cartridge. The purification module includes a rotary valve having a stator with a stator face and passages, and a rotor with a rotational axis, a rotor valving face, and a flow channel with an inlet and an outlet at the rotor valving face.
A retention element biases the stator and the rotor together at a rotor-stator interface to form a fluid tight seal, and a gasket is interposed between the stator face and the rotor valving face. The gasket has a pair of openings in fluidic communication with the flow channel inlet and the flow channel outlet, and the rotary valve has a storage configuration and an operational configuration, wherein in the operational configuration the gasket forms a fluid tight seal between the stator face and the rotor valving face.
A method of operating the rotary valve transitions the rotary valve from the storage configuration into the operational configuration and indexes the rotary valve into a zero valving position for dead end filling of a lysis chamber within the lysis module using a sample suspected of containing one or more target pathogens. The method includes mixing the sample with at least one lysis reagent within the lysis chamber without moving the rotary valve from the zero valving position, then indexing to a valving position to provide fluidic communication between the lysis chamber, a porous solid support within the rotary valve, and a waste collection element.
The method passes the lysed sample through the porous solid support to capture nucleic acid on the porous solid support. The rotary valve is further indexed into additional valving positions for wash buffer flow through the porous solid support into the waste collection element, removal of residual volatile components of the wash buffer from the porous solid support, and routing elution buffer through the porous solid support to fluidically connect an elution buffer reservoir and a rehydration chamber to generate an enriched nucleic acid solution.
Claims Coverage
The provided claims include two independent claims. They are directed to an integrated diagnostic cartridge and to a method of operating a rotary valve in an integrated testing cartridge, with core inventive features centered on module integration, rotary valve structure and sealing, and rotary-valve processing for nucleic acid capture.
Module-linked integrated diagnostic cartridge with rotary valve purification
An integrated diagnostic cartridge comprising a loading module, a lysis module, a purification module comprising a rotary valve, and a reaction module, with fluidic communication between the loading module and the lysis module and between the purification module and the reaction module. The rotary valve includes a stator, a rotor, a retention element biasing the stator and rotor together to form a fluid tight seal, and a gasket interposed between the stator face and the rotor valving face.
Rotary valve storage-to-operational processing with dead-end lysis and nucleic acid capture
A method of operating a rotary valve of an integrated testing cartridge for processing a sample suspected of containing one or more target pathogens, comprising transitioning from a storage configuration into an operational configuration, indexing to a zero valving position for dead end filling a lysis chamber, mixing the sample with at least one lysis reagent without moving the rotary valve from the zero valving position, indexing to a first valving position for fluidic communication with a porous solid support and a waste collection element, passing the lysed sample through the porous solid support to capture a nucleic acid, and indexing into further valving positions for wash buffer flow, removal of residual volatile components, and routing elution buffer to generate an enriched nucleic acid solution.
Across the two independent claims, the core coverage combines an integrated cartridge architecture linking loading, lysis, purification, and reaction modules through a rotary-valve-based purification module, and a rotary-valve operating sequence that transitions storage to operational configuration, performs dead-end lysis at a zero valving position, and directs lysed sample through a porous solid support to capture nucleic acid.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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