# US 11,442,035 B2 · Electrochemical test sensor

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- Number: US 11,442,035 B2
- Document ID: US11442035B2
- Status: Granted
- Kind: B2
- Application number: 15/800,866
- Filed: 2017-11-01
- Published: 2018-03-01
- Granted: 2022-09-13
- Earliest claimed: 2007-12-10
- Assignees: Ascensia Diabetes Care Holdings AG
- Applicants: Ascensia Diabetes Care Holdings AG
- Inventors: Boru Zhu; Herbert Henley, Jr.
- Web page: https://patentgrep.com/patent/US11442035B2

## CPC

- G01N 27/3271: {Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood (amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001)}
- B05C 5/0225: {characterised by flow controlling means, e.g. valves, located proximate the outlet (B05C5/0258, B05C5/0275 take precedence; supply valves upstream the coating head B05C11/1036)}
- C12Q 1/004: {mediator-assisted}
- C12Q 1/006: {for glucose}
- G01N 27/3272: {Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52)}
- G01N 27/128: {Microapparatus}
- 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)
- B05C: APPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL (spraying apparatus, atomising apparatus, nozzles B05B; plant for applying liquids or other fluent materials to objects by electrostatic spraying B05B5/08)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

A method of depositing reagent on an electrochemical test sensor adapted to determine information relating to an analyte includes providing a base and forming an electrode pattern on the base. The method further includes depositing the reagent on at least the electrode pattern using a reagent-dispensing system. The reagent-dispensing system applies mechanical force to the reagent in the reagent-dispensing system to assist in providing a wet reagent droplet on at least the electrode pattern.

## Claims

### Claim 1

An electrochemical test sensor comprising a base, a lid, a plurality of electrodes and a dried reagent, the dried reagent comprise an enzyme, a mediator, a cellulose polymer and a multivalent salt such that dried reagent has a uniformity in which the ratio of the thinnest point to the thickest point is greater than about 0.2, the enzyme including glucose dehydrogenase, the mediator including a 3-phenylimino-3H-phenothiazine or a 3-phenylimino-3H-phenoxazine.

### Claim 2 (depends on 1)

The electrochemical test sensor of claim 1, wherein the enzyme includes flavin adenine dinucleotide-glucose dehydrogenase (FAD-GDH).

### Claim 3 (depends on 1)

The electrochemical test sensor of claim 1, wherein the multivalent salt includes a sulfate or a phosphate.

### Claim 4 (depends on 3)

The electrochemical test sensor of claim 3, wherein the multivalent salt includes sodium phosphate.

### Claim 5 (depends on 1)

The electrochemical test sensor of claim 1, wherein the multivalent salt has a concentration greater than 40 mM in the reagent solution.

### Claim 6 (depends on 5)

The electrochemical test sensor of claim 5, wherein the multivalent salt has a concentration greater than 50 mM in the reagent solution.

### Claim 7 (depends on 6)

The electrochemical test sensor of claim 6, wherein the multivalent salt has a concentration greater than 75 mM in the reagent solution.

### Claim 8 (depends on 1)

The electrochemical test sensor of claim 1, wherein the cellulose polymer is hydroxyethyl cellulose.

### Claim 9 (depends on 1)

The electrochemical test sensor of claim 1, wherein the dried reagent has a uniformity in which the ratio of the thinnest point to the thickest point is greater than 0.3.

### Claim 10 (depends on 9)

The electrochemical test sensor of claim 9, wherein the dried reagent has a uniformity in which the ratio of the thinnest point to the thickest point is greater than about 0.4.

### Claim 11 (depends on 1)

The electrochemical test sensor of claim 1 further including a polyelectrolyte including at least 0.1 wt. % of the reagent solution.

### Claim 12 (depends on 11)

The electrochemical test sensor of claim 11, wherein the polyelectrolyte is selected from the group consisting of carboxymethyl cellulose (CMC), homopolymer and copolymers of arylic acid, malaic acid, styrenesulfonic acid, vinylsulfonic acid, copolymers and salts thereof.

### Claim 13 (depends on 11)

The electrochemical test sensor of claim 11, wherein the reagent solution includes at least about 0.3 wt. % polyelectrolytes.

### Claim 14 (depends on 13)

The electrochemical test sensor of claim 13, wherein the reagent solution includes at least about 0.4 wt. % polyelectrolytes.

### Claim 15

An electrochemical test sensor comprising a base, a lid, a plurality of electrodes and a dried reagent, the dried reagent comprise an enzyme, a mediator, a cellulose polymer and a multivalent salt such that dried reagent has a uniformity in which the ratio of the thinnest point to the thickest point is greater than about 0.2, the multivalent salt including sodium phosphate, the enzyme including flavin adenine dinucleotide-glucose hydrogenase (FAD-GDH), the mediator including a 3-phenylimino-3H-phenothiazine or a 3-phenylimino-3H-phenoxazine.

### Claim 16 (depends on 15)

The electrochemical test sensor of claim 15, wherein the multivalent salt has a concentration greater than 40 mM in the reagent solution.

### Claim 17 (depends on 16)

The electrochemical test sensor of claim 16, wherein the multivalent salt has a concentration greater than 50 mM in the reagent solution.

### Claim 18 (depends on 15)

The electrochemical test sensor of claim 15, wherein the cellulose polymer is hydroxyethyl cellulose.

### Claim 19 (depends on 15)

The electrochemical test sensor of claim 15, wherein the dried reagent has a uniformity in which the ratio of the thinnest point to the thickest point is greater than about 0.4.

### Claim 20 (depends on 15)

The electrochemical test sensor of claim 15, wherein the reagent solution includes at least about 0.3 wt. % polyelectrolytes.