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-10820847-B1
Publication Date
2020-11-03
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 invention is an integrated diagnostic system for point-of-care molecular diagnostics that uses an integrated diagnostic cartridge together with a multi-subsystem diagnostic instrument. The cartridge includes a loading module, a lysis module, a purification module, and a reaction module arranged for use in a vertical orientation, and the modules are in fluidic communication.
A key aspect is fluid handling that changes with cartridge orientation. When the cartridge is in a horizontal sample loading orientation, the fluid inlet accesses a fill chamber via an upper surface of the cartridge, and when the cartridge is in a vertical sample processing orientation, the fluid inlet is positioned adjacent to an upper portion of the fill chamber with the fluid outlet arranged for sample to flow out of a lower portion of the fill chamber. The described cartridge architecture includes fill chamber, metering and overflow loading chambers, and fluidic inlet/outlet structures with frangible seals.
The purification module is implemented using a rotary-valve module with porous solid support and fluid-tight sealing formed at a rotor-stator interface by a retention element biasing the stator and rotor together. The reaction module comprises individual assay chambers using transmissive plug structures with dried reagent, where at least a surface in each assay chamber is provided by a plug with a body transmissive to excitation wavelengths and emission wavelengths.
Claims Coverage
Independent claims clm-00001 and clm-00024 define the integrated diagnostic cartridge. Across these two independent claims, the main inventive features include vertically oriented module arrangement with orientation-dependent fluid inlet/outlet access, module-to-module fluidic communication, rotary-valve purification with porous solid support and fluid-tight sealing, and reaction module assay chambers using transmissive plugs bearing dried reagent.
Orientation-dependent fluid inlet and outlet access with vertical module arrangement
The loading module, lysis module, purification module and reaction module are arranged for use while the cartridge is in a vertical orientation, and the fluid inlet accesses the fill chamber via an upper surface in a horizontal sample loading orientation while in a vertical sample processing orientation the fluid inlet is positioned adjacent to an upper portion of the fill chamber and the fluid outlet is arranged for sample to flow out of a lower portion of the fill chamber.
Fluidic communication between loading, lysis, purification, and reaction modules
The loading module is in fluidic communication with the lysis module and the purification module is in fluidic communication with the reaction module.
Rotary-valve purification with porous solid support and fluid-tight sealing
The purification module comprises a rotary valve including a stator, a rotor, a porous solid support in a flow channel, and a retention element biasing the stator and the rotor together at a rotor-stator interface to form a fluid tight seal.
Reaction module assay chambers with transmissive plug and dried reagent
The reaction module comprises a plurality of individual assay chambers, wherein at least one surface in each assay chamber is provided by a plug comprising a body transmissive to excitation wavelengths and emission wavelengths and a dried reagent on the bottom surface.
Together, the independent claims cover an integrated diagnostic cartridge with modules arranged for vertical use, orientation-dependent fill chamber access for loading, defined fluidic communication among modules, rotary-valve purification using porous solid support and fluid-tight stator/rotor sealing, and reaction assay chambers that use plugs with dried reagent and transmissive optical material for excitation and emission wavelengths.
Stated Advantages
Enables operation with defined fluid inlet access and lower portion outflow depending on cartridge orientation.
Provides fluid-tight sealing at a rotary valve rotor-stator interface for the purification module.
Supports optical detection by using plug body materials transmissive to excitation wavelengths and emission wavelengths.
Documented Applications
Diagnostic testing using the integrated diagnostic cartridge, with optical detection of a fluorescent signal and example CT and NG detection (Chlamydia trachomatis/Neisseria gonorrhoeae) including positive control beta actin and time-to-positive values.
Early insufficient-sample-volume detection and cartridge ejection within the diagnostic system.
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