Systems, methods, and devices for sample collection, stabilization and preservation
Inventors
Jackson, Alicia • Chapman, Rowan • Maichin, Diana • Glorikian, Harry
Assignees
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Publication Number
US-11266337-B2
Publication Date
2022-03-08
Expiration Date
Abstract
Herein, systems and methods are disclosed including a sample acquisition component (SAC) for user-friendly sample collection, a separation component for optional separation of plasma, and one or more stabilization components for stabilizing analytes. In a particular embodiment, the system and methods are directed towards sample collection and stabilization with optional sample separation. Other embodiments can perform any combination of collection, separation, stabilization or detection.
Core Innovation
The invention relates to a method for collecting a bio-sample from a subject using an integrated sample acquisition and sample stabilization device. The device comprises a sample acquisition component having piercing elements and more than one paper stabilization matrix, wherein the more than one paper stabilization matrices are stacked and do not contact each other, and they are separated by one or more solid supports that do not comprise filters.
In use, the device is applied to a skin of the subject, and the sample acquisition component is actuated such that the piercing elements puncture the skin. The piercing elements are withdrawn under vacuum, causing the bio-sample to enter an opening in the sample acquisition component, and the bio-sample is moved from the opening through a channel onto the stacked paper stabilization matrices by vacuum.
The bio-sample is collected on the more than one paper stabilization matrices, and the described stabilization approach includes stabilizing nucleic acids and/or proteins using dried solid matrices and stabilizing reagents. The disclosure further describes stabilization of RNA integrity targets via RIN and ambient storage, as well as downstream workflows for eluting analytes from the stabilization matrices for assay performance, including PCR, sequencing, and RT-PCR.
Claims Coverage
The partial content identifies one independent claim (clm-00001). It covers an integrated method in which bio-sample acquisition under vacuum is combined with collection onto more than one stacked, non-contacting paper stabilization matrices separated by non-filter solid supports, with vacuum-driven transport through a channel.
Stacked non-contact paper stabilization matrices separated by non-filter solid supports
A device includes a sample acquisition component with piercing elements and more than one paper stabilization matrix that are stacked and do not contact each other, wherein the matrices are separated by one or more solid supports that do not comprise filters.
Vacuum puncture and withdrawal for bio-sample entry into the acquisition component
The method applies the device to skin, actuates the sample acquisition component so piercing elements puncture the skin, and withdraws the piercing elements under vacuum causing the bio-sample to enter an opening in the sample acquisition component.
Vacuum-driven transport through a channel onto stacked paper stabilization matrices
The method moves the bio-sample from the opening through a channel onto more than one paper stabilization matrices that are stacked and do not contact each other, wherein the moving onto the stacked non-contacting matrices occurs by vacuum.
Independent claim coverage centers on integrating piercing-element sample acquisition with vacuum-based transport onto stacked, non-contacting paper stabilization matrices separated by non-filter solid supports, enabling bio-sample collection on the stabilization matrices while the transport is performed by vacuum.
Stated Advantages
Not explicitly described in patent.
Documented Applications
PCR, sequencing, and RT-PCR.
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