# US 2014/0154718 A1 · Biosensors and Porous Particle Reagent Compositions

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- Number: US 2014/0154718 A1
- Document ID: US20140154718A1
- Status: Published application
- Kind: A1
- Application number: 14/094,032
- Filed: 2013-12-02
- Published: 2014-06-05
- Earliest claimed: 2007-12-10
- Assignees: Bayer HealthCare LLC
- Applicants: Bayer HealthCare LLC
- Inventors: Boru Zhu
- Web page: https://patentgrep.com/patent/US20140154718A1

## CPC

- C12Q 1/006: {for glucose}
- C12Q 1/002: {Electrode membranes}
- C12Q 1/004: {mediator-assisted}
- C12Q 1/26: involving oxidoreductase
- C12Q 1/54: involving glucose or galactose
- G01N 27/3272: {Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52)}
- G01N 27/3273: {Devices therefor, e.g. test element readers, circuitry (details not specific to biochemical electrodes G01N33/4875)}
- G01N 33/5438: {Electrodes}
- C12N 11/14: Enzymes or microbial cells immobilised on or in an inorganic carrier
- 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
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

A reagent composition for a biosensor sensor strip is disclosed that provides for rapid rehydration after drying. The composition includes porous particles and is preferably formed as a colloidal suspension. The dried reagent composition including porous particles may provide analytically useful output from the sensor strip in a shorter time period than observed from dried reagent compositions using solid particles. The output signal from the porous particle compositions may be correlated to the analyte concentration of a sample within about two seconds. In this manner, an accurate concentration determination of an analyte concentration in a sample may be obtained in less time than from sensor strips including conventional compositions. The reagent composition including the porous particles also may allow for the redox reaction between the reagents and the analyte to reach a maximum kinetic performance in a shorter time period than observed from conventional sensor strips.

## Claims

### Claim 1

A biosensor system, for determining the concentration of an analyte in a sample, comprising:
a support means for supporting at least two conductors;
a reaction means for selectively performing a redox reaction on an analyte, where the reaction means include at least one polymeric material; and
a measurement means for measuring a rate of redox of the analyte, where the measurement means includes at least two conductors;
where the measurement means measures a rate of the redox reaction at a maximum kinetic performance within less than three seconds of introducing a sample to the reaction means; and
where the maximum kinetic performance is determined with a gated amperometric pulse sequence having at least five duty cycles, where
each excitation of the duty cycles is 0.4 seconds in duration,
each relaxation of the duty cycles is one second in duration,
the relaxations are provided by an open circuit,
at least three output current values are measured during each excitation,
the excitations have a substantially constant potential of 250 mV, and
the sample temperature is 23° C.

### Claim 2 (depends on 1)

The system of claim 1, the reaction means including from 0.1 active units to 10 active units per microliter of at least one enzyme system.

### Claim 3 (depends on 2)

The system of claim 2, the reaction means including from 0.5% to 10% (w/w) of at least one mediator.

### Claim 4 (depends on 1)

The system of claim 1, the reaction means further comprising from 0.01% to 1% (w/w) of at least one surfactant.

### Claim 5 (depends on 1)

The system of claim 1, the reaction means further comprising porous particles having an average diameter from 0.05 micrometer to 10 micrometer and a void volume of at least 20% (v/v).

### Claim 6 (depends on 5)

The system of claim 5, the porous particles having an average pore volume from 0.5 to 1 milliliter per gram.

### Claim 7 (depends on 5)

The system of claim 5, the porous particles having an average surface area from 100 to 200 meter2 per gram.

### Claim 8 (depends on 1)

The system of claim 1, where the rate of the redox reaction at the maximum kinetic performance is measured within from 2 to 2.5 seconds of introducing the sample to the reaction means.

### Claim 9 (depends on 1)

The system of claim 1, where the maximum kinetic performance is reached when an initial current value obtained from an excitation having decaying current values is the greatest initial current value obtained from the at least five duty cycles.

### Claim 10 (depends on 1)

The system of claim 1, where the maximum kinetic performance is reached when a last in time current value obtained from an excitation having decaying current values is the greatest last in time current value obtained from the at least five duty cycles.

### Claim 11 (depends on 1)

The system of claim 1, where the maximum kinetic performance is reached during a time period from when an initial current value obtained from an excitation having decaying current values is the greatest initial current value obtained from the at least five duty cycles to when a last in time current value obtained from the same excitation is the greatest last in time current value obtained from the at least five duty cycles.

### Claim 12 (depends on 1)

The system of claim 1, where the analyte comprises glucose, where the sample comprises whole blood, and where the measurement means measures the maximum kinetic performance of the redox reaction within substantially the same time of introducing the sample to the reaction means for glucose concentrations of from 100 mg/dL to 300 mg/dL in the sample.

### Claim 13

A method of determining the concentration of an analyte in a sample, comprising:
introducing a sample to a biosensor, the biosensor comprising a reagent composition, the reagent composition comprising porous particles;
oxidizing or reducing a portion of the analyte present in the sample;
oxidizing or reducing a measurable species with an input signal;
measuring an output current signal;
allowing the sample to undergo relaxation, and
correlating at least one output current value with the analyte concentration of the sample.

### Claim 14 (depends on 13)

The method of claim 13, where the oxidizing or reducing the analyte is with an oxidoreductase.

### Claim 15 (depends on 13)

The method of claim 13, where the input signal includes at least one pulse interval including an excitation and a relaxation.

### Claim 16 (depends on 15)

The method of claim 15, where the pulse interval is less than 3 seconds.

### Claim 17 (depends on 15)

The method of claim 15, where the excitation pulse width is between 0.1 and 2.0 seconds.

### Claim 18 (depends on 15)

The method of claim 15, where, during the relaxation, the current present during the excitation is reduced by at least one-half.

### Claim 19 (depends on 15)

The method of claim 15, where, during the relaxation, the current present during the excitation is reduced by at one order of magnitude.

### Claim at position 20

-25. (canceled)

### Claim 26

A biosensor for determining the concentration of an analyte in a sample, comprising a sensor strip and a measurement device,
the sensor strip comprising:
a reservoir defining a partially-enclosed volume;
a working electrode comprising a reagent composition, the reagent composition comprising porous particles, an enzyme system, and a mediator;
a counter electrode; and
a sample interface;
the measurement device comprising:
a sensor interface;
a processor; and
a signal generator;
the signal generator providing an electrical input signal to the sensor interface;
the processor being capable of directing the signal generator to provide the electrical input signal to the sensor interface, receiving an output signal from the sensor interface, and measuring the output signal to obtain a current value from an excitation where the initial current value is greater than those that follow in the decay and within less than 3 seconds of introducing the sample to the sensor strip.

### Claim at position 22

-34. (canceled)