# US 2013/0157889 A1 · Detection devices and related methods of use

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- Number: US 2013/0157889 A1
- Document ID: US20130157889A1
- Status: Published application
- Kind: A1
- Application number: 13/698,383
- Filed: 2011-05-17
- Published: 2013-06-20
- Earliest claimed: 2010-05-17
- Assignees: Duke University
- Inventors: Ashutosh Chilkoti; Angus Hucknall
- Web page: https://patentgrep.com/patent/US20130157889A1

## CPC

- G01N 33/54366: {Apparatus specially adapted for solid-phase testing}
- A61B 5/150022: {for capillary blood or interstitial fluid}
- A61B 5/150358: {Strips for collecting blood, e.g. absorbent}
- A61B 5/150755: {Blood sample preparation for further analysis, e.g. by separating blood components or by mixing}
- A61B 5/15142: {Devices intended for single use, i.e. disposable}
- A61B 5/157: {Devices} characterised by integrated means for measuring characteristics of blood
- 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}
- A61B 5/1411: {by percutaneous method, e.g. by lancet}
- A61B 2562/0295: Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

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

## Claims

### Claim 1

A device comprising:
a. a substrate comprising a surface;
b. a non-fouling polymer layer on the surface;
c. at least one capture region on the polymer layer, comprising at least one capture agent; and
d. at least one labile region on the polymer layer, comprising at least one detection agent and an excipient;
wherein the capture region and the labile region are spatially separated.

### Claim 2 (depends on 1)

The device according to claim 1, wherein the non-fouling polymer layer comprises a plurality of brush molecules.

### Claim 3 (depends on 2)

The device according to claim 2, wherein at least one of the plurality of brush molecules comprises a monomer core group.

### Claim 4 (depends on 3)

The device according to claim 3, wherein the monomer core group is selected from styrenes, acrylonitriles, acetates, acrylates, methacrylates, acrylamides, methacrylamides, vinyl alcohols, vinyl acids, and combinations thereof.

### Claim 5 (depends on 2)

The device according to claim 2, wherein at least one of the plurality of brush molecules comprises a protein-resistant head group.

### Claim 6 (depends on 5)

The device according to claim 5, wherein the protein-resistant head group comprises a hydrophilic head group or a kosmotrope.

### Claim 7 (depends on 6)

The device according to claim 6, wherein the protein-resistant head group comprises a saccharide, an oligosaccharide, tri(propyl sulfoxide), hydroxyl, glycerol, phosphorylcholine, tri(sarcosine), N-acetylpiperazine, betaine, carboxybetaine, sulfobetaine, permethylated sorbitol, —CH2N+(CH3)2CH2CH2CH2SO3−, hexamethylphosphoramide, or poly(ethylene glycol).

### Claim 8 (depends on 2)

The device according to claim 2, wherein the non-fouling polymer layer comprises poly(oligo(ethylene glycol)methyl methacrylate).

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 9)

The device according to claim 9, wherein the plurality of capture regions comprise at least two different capture agents.

### Claim 11 (depends on 9)

The device according to claim 9, wherein each of the plurality of capture regions comprises a different capture agent.

### Claim at position 12

12-17. (canceled)

### Claim 18 (depends on 1)

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

### Claim at position 14

19-23. (canceled)

### Claim 24 (depends on 1)

The device according to claim 1, wherein at least one labile region further comprises heparin an anticoagulant.

### Claim 25 (depends on 1)

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

### Claim 26 (depends on 1)

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

### Claim at position 18

27-29. (canceled)

### Claim 30 (depends on 1)

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;
c. printing at least one capture agent onto the polymer layer; and
d. printing at least one detection agent and at least one excipient onto the polymer layer;
wherein the capture agent is printed onto the polymer layer in a region that is spatially separated from the detection agent and excipient.

### Claim 31 (depends on 1)

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.

### Claim 32

(canceled)

### Claim 33 (depends on 1)

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.

### Claim 34

(canceled)

### Claim 35 (depends on 33)

The diagnostic assay of claim 33, wherein the assay is a point-of-care assay.

### Claim 36 (depends on 1)

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