Device, system and method processing a sample
Inventors
Lee, Helen Hwai-an • Dineva, Magda Anastassova • Wisniewski, Craig Alan • Stankus, Phillip John
Assignees
Cambridge Enterprise Ltd • Diagnostics for the Real World Ltd
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Publication Number
US-10315195-B2
Publication Date
2019-06-11
Expiration Date
Abstract
A device for the processing of a sample comprises a location apparatus, a processing chamber for receiving the sample and a plurality of reagent chambers. The reagent chambers have openings defined in the location apparatus. The processing chamber is movable relative to the reagent chambers to enable sequential communication with each reagent chamber in turn.
Core Innovation
The invention relates to a device and a method of processing a sample for on-site nucleic acid testing in a closed-system manner. The device includes a location apparatus, a processing chamber for receiving the sample having an opening, and one or more reagent chambers, each reagent chamber having an associated opening defined in the location apparatus. The processing chamber is movable relative to the one or more reagent chambers to enable sequential communication between the processing chamber and each reagent chamber through overlapping openings.
A sealing apparatus forms a circumferential seal around the opening of the processing chamber and the associated opening of each reagent chamber. The seal element seals the processing chamber and the one or more reagent chambers from the external environment throughout movement of the processing chamber relative to the one or more reagent chambers, and throughout the communication between the processing chamber and the one or more reagent chambers. This arrangement is used so that the sample cannot escape from the device during processing of the sample.
The method comprises loading the sample into the processing chamber, moving the processing chamber relative to the one or more reagent chambers, and introducing a reagent into the processing chamber from a reagent chamber. The disclosure further describes reagent chambers as pre-loaded dry freeze-dried lyophilised and couplable liquid reagent chambers, enabling sequential reagent transfer via overlapping openings while maintaining circumferential sealing during communication.
The disclosure also addresses downstream nucleic-acid contamination and decontamination concepts, including a UDG uracil DNA glycosylase based dUTP UDG approach, within the context of a sealed closed-system workflow. An analyser chamber is optionally described, coupled via an associated opening in an overlapping relationship to the processing chamber opening, for analysis by a test strip dipstick readout, and concrete embodiments such as rotating circular-locus chamber stations and a multi-chamber capillary plunger architecture are described for the amplification workflow.
Claims Coverage
The partial content provides three independent claims: clm-00001, clm-00025, and clm-00027. Across these independent claims, the main inventive features are a movable processing chamber enabling sequential communication via overlapping openings, and a sealing apparatus that forms circumferential seals to prevent sample escape from the external environment throughout movement and communication.
Movable processing chamber for sequential reagent communication via overlapping openings
A device is defined with a location apparatus and a processing chamber for receiving the sample having an opening, plus one or more reagent chambers each having an associated opening defined in the location apparatus; the processing chamber is movable relative to the one or more reagent chambers to enable sequential communication such that each reagent chamber communicates with the processing chamber when its associated opening is disposed in overlapping relationship with the processing chamber opening.
Circumferential sealing to prevent sample escape during movement and communication
A sealing apparatus comprising a seal element forms a circumferential seal around the opening of the processing chamber and the associated opening of each reagent chamber, sealing the processing chamber and the one or more reagent chambers from the external environment throughout movement of the processing chamber relative to the one or more reagent chambers and throughout communication between the processing chamber and the one or more reagent chambers, so that the sample cannot escape from the device during processing of the sample.
Closed-sequence processing steps with loading, movement, and reagent introduction
The method comprises the steps of loading the sample into the processing chamber, moving the processing chamber relative to the one or more reagent chambers, and introducing a reagent into the processing chamber from a reagent chamber.
Multiple reagent chambers with first reagent introduction
In an embodiment with a plurality of reagent chambers, the method includes loading the sample into the processing chamber, moving the processing chamber relative to the reagent chambers, and introducing a first reagent into the processing chamber from a first reagent chamber.
Reagent chamber communication through overlapping openings for first reagent introduction
In a device with a reagent chamber having an associated opening defined in the location apparatus, the processing chamber being movable relative to the reagent chamber enables communication such that the reagent chamber communicates with the processing chamber when its associated opening is disposed in overlapping relationship with the processing chamber opening; the method comprises loading the sample into the processing chamber, moving the processing chamber relative to the reagent chamber, and introducing a first reagent into the processing chamber from the reagent chamber.
All independent claims cover a sealed closed-system workflow in which a movable processing chamber sequentially aligns overlapping openings with reagent chamber openings to enable communication, while a circumferential seal element maintains sealing from the external environment during both movement and communication; the method steps are loading, moving, and introducing a reagent into the processing chamber.
Stated Advantages
So that the sample cannot escape from the device during processing of the sample.
Documented Applications
On-site nucleic acid testing in a sealed closed-system operation, including amplification workflows and downstream analysis using a test strip/dipstick in an analyser chamber.
Decontamination of nucleic-acid contamination using a UDG-based dUTP/UDG concept as part of a closed-system workflow.
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