# US 2017/0285016 A1 · Physical Characteristic Determination of a Biological Sample

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- Number: US 2017/0285016 A1
- Document ID: US20170285016A1
- Status: Published application
- Kind: A1
- Application number: 15/465,176
- Filed: 2017-03-21
- Published: 2017-10-05
- Earliest claimed: 2016-03-22
- Assignees: Conductive Technologies, Inc.
- Applicants: Conductive Technologies, Inc.
- Inventors: Matthew K. Musho; Christina A. Beaverson; Nicholas F. Szabo
- Web page: https://patentgrep.com/patent/US20170285016A1

## CPC

- G01N 33/15: Medicinal preparations {; Physical properties thereof, e.g. dissolubility}
- G01N 27/3272: {Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52)}
- G01N 27/3274: {Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration (coding of calibration information G01N33/48771)}
- G01N 33/00: Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- 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)

## Abstract

Test sensors, methods, and systems are described that include a first electrode pair having either two active electrodes or an inactive working electrode paired with an active counter electrode. These active electrodes are different than having an electron transfer mediator on an inactive electrode because in addition to the structural differences between an electrode directly in contact with the conductors of the test sensor verses a reagent coating, there are chemical and functional differences. The active electrodes are formed from an electrode core material including an element that loses or acquires electrons during the analysis and directly participates in the electrochemical reaction of the sample. As the active electrodes are insoluble in the sample during the analysis, an electrochemically stable potential is provided by the active electrodes that can reliably operate at higher operating potentials than conventional electron transfer mediator reagents coated on an inactive electrode.

## Claims

### Claim 1

A test sensor for determining a corrected analyte concentration of a sample comprising:
a substrate;
at least two electrical conductor contacts and at least two electrical conductors, each electrical conductor contact in electrical communication with an electrical conductor, where the electrical conductor contacts are on the substrate;
a lid on the substrate forming a sample reservoir with the substrate, the sample reservoir comprising an inlet port; and
at least two pair of electrodes in the sample reservoir in electrical communication with the electrical conductors, where
a first electrode pair in the sample reservoir includes an active counter electrode, and
a second electrode pair in the sample reservoir includes an analyte specific ionizing agent on a working electrode of the second electrode pair.

### Claim 2 (depends on 1)

The test sensor of claim 1, the first electrode pair lacking an electron transfer mediator on either electrode of the first electrode pair.

### Claim 3 (depends on 1)

The test sensor of claim 1, the first electrode pair lacking the analyte specific ionizing agent on either electrode of the first electrode pair.

### Claim 4 (depends on 1)

The test sensor of claim 1, the active counter electrode comprising an electrode core consisting essentially of a substantially homogenous core material.

### Claim 5 (depends on 1)

The test sensor of claim 1, the active counter electrode comprising an electrode core material selected from the group consisting of silver and silver chloride salt (Ag/AgCl) and silver metal and carbon (AgC).

### Claim 6 (depends on 1)

The test sensor of claim 1, the first electrode pair further comprising an active working electrode.

### Claim 7 (depends on 6)

The test sensor of claim 6, the active working electrode comprising an electrode core consisting essentially of a substantially homogenous core material.

### Claim 8 (depends on 6)

The test sensor of claim 6, the active counter electrode and the active working electrode comprising an electrode core material including silver and silver chloride salt (Ag/AgCl).

### Claim 9 (depends on 8)

The test sensor of claim 8, the electrode core material including from 70% to 90% (weight/weight) silver.

### Claim 10 (depends on 6)

The test sensor of claim 6, the active counter electrode and the active working electrode comprising an electrode core material including a mixture of silver metal and carbon (AgC).

### Claim 11 (depends on 10)

The test sensor of claim 10, the electrode core material including from 20% to 60% (weight/weight) silver metal and non-silver metal core material, where the non-silver metal core material is at least 90% (weigh/weight) carbon.

### Claim 12 (depends on 1)

The test sensor of claim 1, the second electrode pair further comprising an electron transfer mediator on the working electrode of the second electrode pair.

### Claim 13 (depends on 1)

The test sensor of claim 1 where the first electrode pair is in closer proximity to the inlet port than the second electrode pair.

### Claim 14 (depends on 1)

The test sensor of claim 1 where the first electrode pair is located in a first reservoir branch of the sample reservoir and the second electrode pair is located in a second branch of the sample reservoir.

### Claim 15

A test sensor for determining a physical characteristic of a sample, comprising:
a substrate;
two electrical conductor contacts and two electrical conductors, each electrical conductor contact in electrical communication with an electrical conductor, where the electrical conductor contacts are on the substrate;
a lid on the substrate forming a sample reservoir with the substrate, the sample reservoir comprising an inlet port; and
one pair of electrodes in the sample reservoir and in electrical communication with the electrical conductors, where
the one pair of electrodes in the sample reservoir includes an active counter electrode.

### Claim 16 (depends on 15)

The test sensor of claim 15, the one electrode pair lacking an electron transfer mediator on either electrode of the one electrode pair.

### Claim 17 (depends on 15)

The test sensor of claim 15, the one electrode pair lacking an analyte specific ionizing agent on either electrode of the one electrode pair.

### Claim 18 (depends on 15)

The test sensor of claim 15, the active counter electrode comprising an electrode core consisting essentially of a substantially homogenous core material.

### Claim 19 (depends on 15)

The test sensor of claim 15, the active counter electrode comprising an electrode core material selected from the group consisting of silver and silver chloride salt (Ag/AgCl) and silver metal and carbon (AgC).

### Claim 20 (depends on 15)

The test sensor of claim 15, the one electrode pair further comprising an active working electrode.

### Claim 21 (depends on 20)

The test sensor of claim 20, the active working electrode comprising an electrode core consisting essentially of a substantially homogenous core material.

### Claim 22 (depends on 20)

The test sensor of claim 20, the active counter electrode and the active working electrode comprising an electrode core material including silver and silver chloride salt (Ag/AgCl).

### Claim 23 (depends on 22)

The test sensor of claim 22, the electrode core material including from 70% to 90% (weight/weight) silver.

### Claim 24 (depends on 20)

The test sensor of claim 20, the active counter electrode and the active working electrode comprising an electrode core material including a mixture of silver metal and carbon (AgC).

### Claim 25 (depends on 24)

The test sensor of claim 24, the electrode core material including from 20% to 60% (weight/weight) silver metal and non-silver metal core material, where the non-silver metal core material is at least 90% (weigh/weight) carbon.

### Claim 26 (depends on 20)

The test sensor of claim 20, where the sample inlet is centrally located over the working electrode.

### Claim 27

A method for determining a corrected analyte concentration of a sample comprising:
applying a potential of at least 400 mV to a pair of electrical conductor contacts in electrical communication with a pair of electrical conductors in electrical communication with a first electrode pair;
generating an electrical output from a second electrode pair responsive to an analyte concentration of a sample, the sample in electrical communication with the second electrode pair;
generating an electrical output from a first electrode pair responsive to a physical characteristic of the sample, the sample in electrical communication with the first electrode pair, the first electrode pair including an active counter electrode;
correcting the electrical output from the second electrode pair with the electrical output from the first electrode pair; and
determining a corrected analyte concentration of the sample.

### Claim at position 28

28-50. (canceled)

### Claim 51

A method for determining a physical characteristic content of a sample, comprising:
applying a potential from 2,000 mV to 6,000 mV to two electrical conductor contacts and two electrical conductors, each electrical conductor contact in electrical communication with an electrical conductor;
generating an electrical output from one electrode pair responsive to a physical characteristic of the sample, the sample in electrical communication with the one electrode pair, the one electrode pair including an active counter electrode; and
determining a physical characteristic content of the sample from the electrical output.

### Claim at position 30

52-66. (canceled)

### Claim 67

A system for determining a corrected analyte concentration of a sample comprising:
a measurement device having contacts in electrical communication with electrical conductor contacts of a test sensor, each electrical conductor contact in electrical communication with an electrical conductor, where the electrical conductor contacts are on a substrate of the test sensor,
the measurement device includes contacts in electrical communication with circuitry including a processor in electrical communication with an electrical input generator and with a storage medium,
the test sensor includes a lid on the substrate forming a sample reservoir with the substrate, the sample reservoir comprising an inlet port,
the test sensor includes at least two pair of electrodes in the sample reservoir in electrical communication with the electrical conductors of the test sensor, where
a first electrode pair in the sample reservoir includes an active counter electrode, and
a second electrode pair in the sample reservoir includes an analyte specific ionizing agent on a working electrode of the second electrode pair;
the electrical input generator is configured to apply an electrical input of at least 400 mV to the contacts of the measurement device in response to an instruction from the processor;
the test sensor is configured to generate an electrical output from the second electrode pair responsive to an analyte concentration of a sample, the sample in electrical communication with the second electrode pair;
the test sensor is configured to generate an electrical output from the first electrode pair responsive to a physical characteristic of the sample, the sample in electrical communication with the first electrode pair, the first electrode pair including an active counter electrode;
the processor is configured to correct the electrical output from the second electrode pair with the electrical output from the first electrode pair in response to non-transient instructions stored in the storage medium; and
the processor is configured to determine a corrected analyte concentration of the sample in response to non-transient instructions stored in the storage medium.

### Claim at position 32

68-91. (canceled)

### Claim 92

A system for determining a physical characteristic of a sample, comprising:
a measurement device having contacts in electrical communication with electrical conductor contacts of a test sensor, each electrical conductor contact in electrical communication with an electrical conductor, where the electrical conductor contacts are on a substrate of the test sensor,
the measurement device includes contacts in electrical communication with circuitry including a processor in electrical communication with an electrical input generator and with a storage medium,
the test sensor includes a lid on the substrate forming a sample reservoir with the substrate, the sample reservoir comprising an inlet port,
the test sensor includes one pair of electrodes in the sample reservoir in electrical communication with the electrical conductors of the test sensor, where the one pair of electrodes in the sample reservoir include an active counter electrode, and
the electrical input generator is configured to apply an electrical input from 2,000 mV to 6,000 mV to the contacts of the measurement device in response to an instruction from the processor;
the test sensor is configured to generate an electrical output from one electrode pair on the substrate responsive to a physical characteristic of the sample, the sample in electrical communication with the one electrode pair, the one electrode pair including an active counter electrode;
the processor is configured to determine a physical characteristic content of the sample in response to non-transient instructions stored in the storage medium.

### Claim at position 34

93-110. (canceled)

### Claim 111

An active electrode pair for participating in the electrochemical reaction of an analyte in a sample, the active electrode pair comprising:
a working electrode conductor;
a working electrode core on the working electrode conductor, the working electrode core consisting essentially of carbon, silver metal, silver chloride, and combinations thereof;
a counter electrode conductor; and
a counter electrode core on the working electrode conductor, the counter electrode core consisting essentially of carbon, silver metal, silver chloride, and combinations thereof, where the silver content of the counter electrode is from 70% to 90% (weight/weight).

### Claim at position 36

112-115. (canceled)
