Device for detecting misfolded proteins and methods of use thereof
Inventors
Davis, Wendy L. • Levenson, Daniel
Assignees
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Publication Number
US-10564153-B2
Publication Date
2020-02-18
Expiration Date
Abstract
The present invention relates to diagnostic devices as well as methods of using these devices for detecting proteins of interest associated with diseases or disorders in mammals. In particular, the proteins of interest may be misfolded proteins associated with certain misfolded-protein disorders in mammals including those mammals suspected of or at risk of having such disorders.
Core Innovation
The invention is a diagnostic device for detection of at least one protein in a biological sample of a mammal. The device includes a sample receiving material configured to receive the biological sample and a detection reagent present on or within the sample receiving material, where the detection reagent binds to at least one protein present in the biological sample and is selected from an azo dye, Thioflavin T, or an analog of an azo dye.
The diagnostic device further includes a trap in contact with the sample receiving material that separates detection reagent bound to the protein from unbound detection reagent. The trap permits flow of detection reagent bound to the protein through the trap while retaining, retarding, or binding unbound detection reagent, and is formed from nitrocellulose, cellulose, a glass fiber, cotton fiber, a woven mesh, a nonwoven material, asymmetric polysulfone membrane, polyvinylidene fluoride, or polyethersulfone.
A capillary bed is in contact with the trap and is configured to contain the biological sample after the sample flows through the trap. The sample receiving material, trap, and capillary bed are configured to be in contact in sequence, and the capillary bed displays the detection reagent if the at least one protein is present in the biological sample.
Claims Coverage
The independent claim is directed to a lateral flow chromatographic diagnostic device architecture with four interacting components that provides a visual readout when the target protein is present. The claim includes 4 inventive features that define functional separation and downstream display, plus defined selections for detection reagent and trap materials.
Diagnostic device with sequential sample receiving, trap, and capillary bed
A diagnostic device for detection of at least one protein in a biological sample of a mammal comprising a sample receiving material, a trap in contact with the sample receiving material, and a capillary bed in contact with the trap, wherein the sample receiving material, trap, and capillary bed are configured to be in contact in sequence and the capillary bed displays detection reagent if said at least one protein is present in said biological sample.
Protein-binding detection reagent on or within the sample receiving material
A detection reagent present on or within said sample receiving material and binds to at least one protein present in said biological sample, wherein said detection reagent is selected from the group consisting of an azo dye, Thioflavin T and an analog of an azo dye.
Trap separating bound versus unbound detection reagent and guiding bound flow to the capillary bed
A trap in contact with the sample receiving material that separates detection reagent bound to said at least one protein in said biological sample from unbound detection reagent; permits flow of detection reagent bound to said at least one protein in said biological sample through said trap; and retains, retards the flow of, or binds said unbound detection reagent.
Defined trap material selection for the separation function
The trap is a material selected from the group consisting of nitrocellulose, cellulose, a glass fiber, a cotton fiber, a woven mesh, a nonwoven material, asymmetric polysulfone membrane, polyvinylidene fluoride and polyethersulfone.
Across the independent claim, the main inventive coverage is the combination of a protein-binding detection reagent immobilized on or in a sample receiving material, a trap that separates bound from unbound detection reagent while allowing bound flow, and a downstream capillary bed that displays the detection reagent when the protein is present, with defined options for detection reagent type and trap materials.
Stated Advantages
Fewer steps
Standardized materials
Improved reagent stability for shelf life
Fast results
Point-of-care usability
Improved discrimination by retaining, retarding, or binding unbound detection reagent while permitting flow of detection reagent bound to the protein
Documented Applications
Detection of misfolded/congophilic/aggregated proteins in mammalian biological samples, with focus on preeclampsia (a hypertensive disorder of pregnancy).
Detection and evaluation of diagnostic performance against the Congo Red dot blot (CRD) test in the context of misfolded protein detection.
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