Biosensor system, sensor chip, and method of measuring analyte concentration in blood sample

• US 9,829,460 B2
• Filed: 12/12/2014
• Issued: 11/28/2017
• Est. Priority Date: 04/07/2008
• Status: Active Grant

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Healthcare Holdings Co., Ltd.
• Inventors: Fujiwara, Masaki
• Primary Examiner(s): Leong, Susan D
• Application Number:
  US14/568,889
• Publication Number:
  US 20150168340A1
• Time in Patent Office: 1,082 Days
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• 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

The present invention provides a biosensor system that can prevent a measurement error caused by the temperature of the environment in use from occurring. A biosensor system 100 includes a measuring instrument 101 having an operation part 306, and a sensor chip 200 that is insertable into and removable from the measuring instrument 101 and into which a blood sample is introduced. The sensor chip 200 includes a measurement part 41 (a measurement part A) that acquires Data a related to the concentration of an analyte in a blood sample based on the amount of electric current that flows in the blood sample due to a reaction in which an oxidoreductase with the analyte used as a substrate is involved, and a measurement part 42 (a measurement part B) that acquires, from the blood sample, Data b for temperature correction of Data a. The operation part 306 has a function of determining the concentration of the analyte in the blood sample, with the concentration having been corrected according to the temperature of the blood sample based on Data a and Data b.

Claims

1. A biosensor system, comprising:

a measuring instrument having an operation part; and

a sensor chip that is insertable into and removable from the measuring instrument, and comprises a capillary part that retains a blood sample introduced into the sensor chip,

wherein the sensor chip comprises

a measurement part A including an electrode A and an electrode B in the capillary part;

a measurement part B including the electrode A and an electrode C in the capillary part,

a reaction reagent layer formed on the electrodes A and B but not on the electrode C, and

a spacer formed on the reaction reagent layer;

wherein

the measuring instrument does not include an environmental temperature measurement part for measuring the environmental temperature;

the measurement part A acquires Data a related to a concentration of an analyte in the blood sample based on the amount of electric current that flows in the blood sample due to a reaction in which an oxidoreductase with the analyte used as a substrate is involved;

the measurement part B acquires Data b suitable for temperature correction of the Data a;

the operation part is configured to determine the concentration of the analyte in the blood sample based on the Data a, as corrected based on the Data b measured by measurement part B, thereby avoiding the influence of the temperature of the blood sample in the measurement of the analyte concentration.

2. The biosensor system according to claim 1, wherein the electrodes A, B and C are formed of conductive materials selected from a group consisting of palladium, platinum, gold, silver, titanium, copper, nickel and carbon.

3. The biosensor system according to claim 1, wherein the spacer has the capillary part, and the height of the capillary part is 0.05 mm to 0.3 mm.

4. The biosensor system according to claim 1, wherein the measuring instrument has a control circuit that provides the measurement part A with a signal that indicates acquisition of the Data a within a range of at least 0.5 second but less than 2.5 seconds from the time when the blood sample has been introduced into the sensor chip.

5. The biosensor system according to claim 1, wherein the reaction reagent layer contains the oxidoreductase,

the reaction reagent layer contains no water-soluble polymer or contains less than 0.2 mass % of water-soluble polymer, and

the measuring instrument has a control circuit that provides the measurement part A with a signal that indicates acquisition of the Data a within a range of at least 0.5 second but less than 2.5 seconds from the time when the blood sample has been introduced into the sensor chip.

6. The biosensor system according to claim 1, wherein the reaction reagent layer contains the oxidoreductase,

the reaction reagent layer contains at least 0.2 mass % of water-soluble polymer, and

the measuring instrument has a control circuit that provides the measurement part A with a signal that indicates acquisition of the Data a after a lapse of at least 2.5 seconds from the time when the blood sample has been introduced into the sensor chip.

7. The biosensor system according to claim 1, wherein the electrode A is a working electrode for the measurement part A and a counter electrode for the measurement part B.