Analyzing Device, Sensor Testing Device, Testing Method and Computer-Readable Storage Medium

• US 20120199496A1
• Filed: 02/02/2012
• Published: 08/09/2012
• Est. Priority Date: 02/03/2011
• Status: Active Grant

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Sekimoto, Shinjiro
• Granted Patent: US 9,297,777 B2
• Time in Patent Office: Days
• US Class Current: 205/775
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

There is provided a sensor testing method including: applying at least one of a first voltage that obtains a response caused by a substance and a second voltage that either obtains no response or substantially no response caused by the substance across a first electrode and a second electrode of a sensor; measuring current flowing between the first electrode and the second electrode; and determining whether or not there is a defect present in the sensor based on a quantity related to an amount of change per specific period of time of a current measured when the first voltage and/or the second voltage have been applied.

Claims

1. An analyzing device comprising:

a sensor section comprising a reagent layer including a reagent that reacts with a substance in a sample liquid, an electrode including a first electrode and a second electrode for applying a voltage to the reagent layer, and an external layer membrane for making contact with the reagent layer;

a voltage application unit for applying across the first electrode and the second electrode at least one of a first voltage that obtains a response caused by the substance and a second voltage that either obtains no response or substantially no response caused by the substance;

a current measurement unit for measuring current flowing between the first electrode and the second electrode; and

a determination unit for determining whether or not there is a defect present in the external layer membrane based on at least one of a first physical quantity related to an amount of change per specific period of time of a first current measured by the current measurement unit when the first voltage has been applied and a second physical quantity related to an amount of change per specific period of time of a second current measured by the current measurement unit when the second voltage has been applied.

2. The analyzing device of claim 1 wherein the first physical quantity is a first time from until the amount of change per specific period of time of the first current reaches a value in a predetermined first specific range and the second physical quantity is a second time until the amount of change per specific period of time of the second current reaches a value in a predetermined second specific range.

3. The analyzing device of claim 1 further comprising a correction unit that corrects the current value measured by the current measurement unit when a defect is determined by the determination unit to have occurred in the external layer membrane, the correction unit performing correction based on at least one of a predetermined first relationship between the first physical quantity and a defect ratio of the external layer membrane, and a predetermined second relationship between the second physical quantity and a defect ratio of the external layer membrane.

4. The analyzing device of claim 3 wherein the correction unit estimates the defect ratio based on at least one of the first relationship and the second relationship, and corrects the current value measured by the current measurement unit based on a predetermined relationship between the defect ratio of the external layer membrane and the current value measured from the sensor section provided with an external layer membrane having defects corresponding to the defect ratio.

5. The analyzing device of claim 4 wherein when the correction unit estimates the defect ratio based on both the first relationship and the second relationship, the correction unit computes the defect ratio as the average value, the maximum value or the minimum value of a first defect ratio estimated based on the first relationship and a second defect ratio estimated based on the second relationship.

6. The analyzing device of claim 1 further comprising an output unit that outputs a signal indicating that a defect has occurred in the sensor section when a defect is determined to have occurred in the external layer membrane by the determination unit.

7. The analyzing device of claim 1 wherein when applying both the first voltage and the second voltage the voltage application unit applies the first voltage and the second voltage alternately.

8. The analyzing device of claim 1 wherein the current measurement unit continuously measures the current flowing between the first electrode and the second electrode, and the determination unit determines the presence or absence of a defect in the external layer membrane at a predetermined timing.

9. The analyzing device of claim 1 wherein during use of the analyzing device the sensor section is disposed under the skin of a user of the analyzing device and the reagent layer reacts to a composition to be tested present under the skin.

10. The analyzing device of claim 1 wherein the reagent layer extracts electrons from the composition to be tested and supplies the extracted electrons to the electrode.

11. The analyzing device of claim 1 wherein the reagent layer includes an enzyme portion for extracting electrons from the composition to be tested.

12. A sensor testing device comprising:

a voltage application unit that applies at least one of a first voltage that obtains a response caused by a substance and a second voltage that either obtains no response or substantially no response caused by the substance across a first electrode and a second electrode of a sensor section configured with a reagent layer including a reagent that reacts with the substance in a sample liquid, an electrode including the first electrode and the second electrode for applying a voltage to the reagent layer, and an external layer membrane for making contact with the reagent layer;

a current measurement unit that measures current flowing between the first electrode and the second electrode; and

a determination unit that determines whether or not there is a defect present in the external layer membrane based on at least one of a first physical quantity related to an amount of change per specific period of time of a first current measured by the current measurement unit when the first voltage has been applied and a second physical quantity related to an amount of change per specific period of time of a second current measured by the current measurement unit when the second voltage has been applied.

13. A sensor testing method comprising:

applying at least one of a first voltage that obtains a response caused by a substance and a second voltage that either obtains no response or substantially no response caused by the substance across a first electrode and a second electrode of a sensor section configured with a reagent layer including a reagent that reacts with the substance in a sample liquid, an electrode including the first electrode and the second electrode for applying a voltage to the reagent layer, and an external layer membrane for making contact with the reagent layer;

measuring current flowing between the first electrode and the second electrode; and

determining whether or not there is a defect present in the external layer membrane based on at least one of a first physical quantity related to an amount of change per specific period of time of a first current measured when the first voltage has been applied and a second physical quantity related to an amount of change per specific period of time of a second current measured when the second voltage has been applied.

14. A non-transitory computer-readable storage medium storing a program for causing a computer to execute a sensor testing method, the sensor testing method comprising:

applying, by a voltage application unit, at least one of a first voltage that obtains a response caused by a substance and a second voltage that either obtains no response or substantially no response caused by the substance across a first electrode and a second electrode of a sensor section configured with a reagent layer including a reagent that reacts with the substance in a sample liquid, an electrode including the first electrode and the second electrode for applying a voltage to the reagent layer, and an external layer membrane for making contact with the reagent layer;

measuring, by a current measurement unit, current flowing between the first electrode and the second electrode; and

determining, by a determination unit, whether or not there is a defect present in the external layer membrane based on at least one of a first physical quantity related to an amount of change per specific period of time of a first current measured by the current measurement unit when the first voltage has been applied and a second physical quantity related to an amount of change per specific period of time of a second current measured by the current measurement unit when the second voltage has been applied.