Detection devices and related methods of use

• US 10,302,636 B2
• Filed: 10/27/2016
• Issued: 05/28/2019
• Est. Priority Date: 05/17/2010
• Status: Active Grant

• Current Assignee: Sentilus Holdco, LLC
• Original Assignee: Sentilus Holdco, LLC
• Inventors: Chilkoti, Ashutosh, Hucknall, Angus
• Primary Examiner(s): White, Dennis
• Application Number:
  US15/336,097
• Publication Number:
  US 20170108496A1
• Time in Patent Office: 943 Days
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54393 Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding

Abstract

Disclosed are devices and methods for detecting analytes from a sample.

Claims

1. A device comprising:

a. a substrate comprising a surface;

b. a non-fouling polymer layer on the surface, wherein the non-fouling polymer layer comprises a film of functionalized poly(oligo(ethylene glycol)methyl methacrylate) brush molecules, the brush molecules comprising a monomeric core group and a protein-resistant head group;

c. at least one capture region on the polymer layer, comprising at least one capture agent, wherein the at least one capture agent binds a target in a sample and the at least one capture agent remains bound to the polymer layer when exposed to the sample; and

d. at least one labile region on the polymer layer, comprising at least one detection agent and an excipient, wherein the at least one detection agent solubilizes upon contact with the sample and binds to and labels the target in the sample;

wherein the capture region and the labile region are spatially separated.

2. The device according to claim 1, wherein the film is obtainable by copolymerization of a methacrylate and methoxy-terminated oligo(ethylene glycol)methyl methacrylate.

3. The device according to claim 1, comprising a plurality of capture regions, each capture region comprising at least one capture agent.

4. The device according to claim 3, wherein the plurality of capture regions comprise at least two different capture agents.

5. The device according to claim 3, wherein each of the plurality of capture regions comprises a different capture agent.

6. The device according to claim 1, wherein the capture agent is a biomarker.

7. The device according to claim 6, wherein the biomarker comprises a cell, a small molecule ligand, a lipid, a carbohydrate, a polynucleotide, a peptide, a protein, an antigen, or an antibody.

8. The device according to claim 1, comprising a plurality of labile regions, each labile region comprising at least one detection agent.

9. The device according to claim 1, wherein the detection agent comprises a cell, a small molecule ligand, a lipid, a carbohydrate, a polynucleotide, a peptide, a protein, an antigen, or an antibody.

10. The device according to claim 1, wherein the detection agent comprises a detection moiety selected from a chromophore, a fluorophore, a radiolabel, a polynucleotide, a small molecule, an enzyme, a nanoparticle, a microparticle, a quantum dot, or an upconverter.

11. The device according to claim 1, wherein the excipient is selected from a salt, a carbohydrate, a sugar, an emulsifier, a water-soluble polymer, and any combination thereof.

12. The device according to claim 1, wherein the substrate comprises glass, silicon, a metal oxide, or a polymer.

13. The device according to claim 1, further comprising a linking layer between the substrate and the polymer layer.

14. The device according to claim 1, further comprising an agent to demarcate a detection region on the surface or on the polymer layer.

15. A method of manufacturing a device according to claim 1, the method comprising:

a. providing a substrate comprising a surface;

b. forming a non-fouling polymer layer on the surface, wherein the non-fouling polymer layer comprises a film of functionalized poly(oligo(ethylene glycol)methyl methacrylate) brush molecules, the brush molecules comprising a monomeric core group and a protein-resistant head group;

c. printing at least one capture agent onto the polymer layer, wherein the at least one capture agent binds a target in a sample and the at least one capture agent remains bound to the polymer layer when exposed to the sample; and

d. printing at least one detection agent and at least one excipient onto the polymer layer, wherein the at least one detection agent solubilizes upon contact with the sample and binds to and labels the target in the sample;

wherein the capture agent is printed onto the polymer layer in a region that is spatially separated from the detection agent and excipient.

16. A method of screening for a disease or a disorder in a subject comprising:

a. obtaining a biological sample from the subject;

b. contacting the biological sample with the device of claim 1 for a time sufficient to allow the detection agent in the labile region to solubilize;

c. detecting the presence of the disease or disorder, wherein a detectable signal on at least one capture region on the device indicates the presence of the disease or disorder in the subject.

17. The method of claim 15, wherein the film is prepared by copolymerization of a methacrylate and methoxy-terminated oligo(ethylene glycol)methyl methacrylate.

18. A diagnostic assay for determining a disease, a disorder, or a biological state in a subject comprising:

a. obtaining a biological sample from the subject;

b. contacting the biological sample with the device of claim 1 for a time sufficient to allow the detection agent in the labile region to solubilize;

c. detecting the presence of the disease, a disorder, or biological state,

wherein a detectable signal on at least one capture region on the device indicates the presence of the disease, disorder, or biological state in the subject.

19. The diagnostic assay of claim 18, wherein the assay is a point-of-care assay.

20. A kit comprising the device according to claim 1, a set of buffers and/or reagents, and instructions for use.