Analyzing device, sensor testing device, testing method and computer-readable storage medium

• US 10,295,495 B2
• Filed: 02/18/2016
• Issued: 05/21/2019
• Est. Priority Date: 02/03/2011
• Status: Active Grant

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Sekimoto, Shinjiro
• Primary Examiner(s): Kaur, Gurpreet
• Assistant Examiner(s): Rosenwald, Steven E
• Application Number:
  US15/046,477
• Publication Number:
  US 20160161439A1
• Time in Patent Office: 1,188 Days
• 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. A method for testing a sensor comprising an external layer membrane, the method comprising:

applying to a reagent layer present in a section of a sensor at least one of a first voltage across a first electrode and a second electrode to generate a response current by reaction of a reagent present in the reagent layer with a target substance in a sample liquid and a second voltage that results in no response current or substantially no response current, where the section of the sensor comprises the reagent layer, an external layer membrane for making contact with the reagent layer, and an electrode section comprising the first electrode and the second electrode;

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

using a computer programmed to compute a time required for an amount of change in the response current per specific amount of change in time resulting from the application of the first voltage to reach a value in a predetermined first specific range prior to when the response current reaches a steady state to determine whether there is a defect present in the external layer membrane, or

using the computer to compute a time required for an amount of change in the response current per specific amount of change in time resulting from the application of the second voltage to reach a value in a predetermined second specific range prior to when the response current reaches a steady state to determine whether there is a defect present in the external layer membrane,

correcting the response current value measured when a defect is determined to be present in the external layer membrane, and

outputting a signal indicating that a defect has occurred in the sensor when a defect is determined to be present in the external layer membrane.

2. The method of claim 1, further comprising:

storing a first relationship between the time required for an amount of change in the response current per specific amount of change in time resulting from the application of the first voltage to reach a value in a predetermined first specific range and a set of defect ratios corresponding to the time required for the response current resulting from the application of the first voltage; and

storing a second relationship between the time required for an amount of change in the response current per specific amount of change in time resulting from the application of the second voltage to reach a value in a predetermined second specific range and a set of defect ratios corresponding to the time required for the response current resulting from the application of the second voltage,

wherein the correcting of the response current value is based on at least one of the first relationship or the second relationship.

3. The method of claim 2, wherein the correcting of the response current value measured is based on a relationship between the defect ratio of the external layer membrane and the response current value measured from the sensor section provided with an external layer membrane having defects corresponding to the defect ratio.

4. The method of claim 3, wherein the defect ratio based on both the first relationship and the second relationship is computed 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.

5. The method of claim 1, wherein the first voltage and the second voltage are applied alternately.

6. The method of claim 1, wherein the section of the sensor is disposed under the skin of a user of the method and the target substance is present under the skin.

7. The method of claim 1, wherein the reagent layer extracts electrons from the target substance and supplies the extracted electrons to the electrode section.

8. The method of claim 1, wherein the reagent in the reagent layer includes an enzyme.