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

• US 8,940,138 B2
• Filed: 04/02/2009
• Issued: 01/27/2015
• 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 DANG
• Application Number:
  US12/935,803
• Publication Number:
  US 20110027816A1
• Time in Patent Office: 2,126 Days
• Field of Search: 20440301-40315, 204/228.6, 205/777.5, 205/778, 205/792, 435 4- 4052, 422/82.12, 422/98
• US Class Current: 204/228.6
• 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 biosensor system prevents a measurement error caused by the temperature of the environment in use. A biosensor system 100 includes a measuring instrument 101 having an operation part 306, and a sensor chip 200 insertable into and removable from the measuring instrument 101 and which accepts a blood sample. The sensor chip 200 includes a measurement part 41 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 sample due to a reaction in which an oxidoreductase with the analyte used as a substrate is involved, and a measurement part 42 that acquires, from the sample, Data b for temperature correction of Data a. The operation part 306 determines the concentration of the analyte in the sample, corrected according to the temperature of the 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 comprises;

a first measurement part including an electrode A and an electrode B; and

a second measurement part including the electrode A and an electrode C,

wherein the first measurement part acquires Data a, related to a concentration of an analyte in a blood sample to be evaluated due to a reaction involving an oxidoreductase with the analyte used as a substrate,

the second measurement part acquires, from the blood sample, Data b, related to an amount of electric current that flows in the blood sample according to oxidation or reduction of a redox substance other than the analyte,

the operation part has a conversion table established using a relationship where the amount of electric current that flows in a blood sample due to the reaction involving the oxidoreductase with the analyte used as a substrate varies in the same manner as the amount of electric current that flows in a blood sample according to oxidation or reduction of a redox substance other than the analyte, when the temperature of the blood sample varies,

the conversion table not including temperature information, and

the operation part is programmed to determine the concentration of the analyte in the blood sample to be evaluated, with the concentration having been corrected according to a temperature of the blood sample to be evaluated based on the Data a and the Data b with reference to the conversion table.

2. The biosensor system according to claim 1, wherein the measuring instrument has a control circuit that provides the first measurement part 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.

3. The biosensor system according to claim 1, wherein the sensor chip has a reaction reagent layer containing 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 first measurement part 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.

4. The biosensor system according to claim 1, wherein the sensor chip has a reaction reagent layer containing 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 first measurement part 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.

5. The biosensor system according to claim 1, wherein in the conversion table, Data c, Data d, and the concentration of the analyte in a reference blood sample corresponding to the Data c and the Data d are described, where the Data c is related to the amount of electric current that flows in the reference blood sample due to the reaction involving the oxidoreductase with the analyte used as a substrate and the Data d is related to the amount of electric current that flows in the reference blood sample according to oxidation or reduction of a redox substance other than the analyte, and the operation part determines the concentration of the analyte in the blood sample to be evaluated based on the Data a and the Data b with reference to the conversion table.

6. The biosensor system according to claim 1, wherein the measuring instrument further comprises an environmental temperature measurement part for measuring the temperature of a measurement environment.

7. The biosensor system according to claim 1, wherein, in the conversion table, Data c, Data d, and the concentration of the analyte in a reference blood sample corresponding to the Data c and the Data d are described, where the Data c is related to an amount of electric current that flows in the reference blood sample due to the reaction involving the oxidoreductase with the analyte used as a substrate and the Data d is related to the amount of electric current that flows in the reference blood sample according to oxidation or reduction of a redox substance other than the analyte,

the operation part further has another conversion table, and

the another conversion table has the Data c and Data e for correcting the Data c according to a temperature of a measurement environment.

10. The biosensor system according to claim 1 wherein in the conversion table, a converted value based on Data c and Data d, and the concentration of the analyte in a reference blood sample corresponding to the Data c and the Data d, are described, where the Data c is related to the amount of electric current that flows in the reference blood sample due to the reaction involving the oxidoreductase with the analyte used as a substrate and the Data d is related to the amount of electric current that flows in the reference blood sample according to oxidation or reduction of a redox substance other than the analyte, and the operation part determines the concentration of the analyte in the blood sample to be evaluated based on the Data a and the Data b with reference to the conversion table.

8. A method of measuring a concentration of an analyte in a blood sample to be evaluated, comprising:

a step of acquiring Data a related to the concentration of the analyte based on an amount of electric current that flows in the blood sample due to a reaction involving an oxidoreductase with the analyte used as a substrate, and a step of acquiring, from the blood sample, Data b for temperature correction of the Data a,

wherein the method is carried out using a sensor chip into which the blood sample is introduced, the sensor chip comprising;

a first measurement part including an electrode A and an electrode B; and

a second measurement part including the electrode A and an electrode C,

the step of acquiring the Data b includes a step of applying voltage to the pair of electrodes A and C that have been brought into contact with the blood sample and measuring the amount of electric current that flows in the blood sample according to oxidation or reduction of a redox substance other than the analyte, and

the method comprising a further step of measuring environmental temperature around the blood sample to be evaluated,

wherein the further step comprises a first temperature measurement step of measuring the environmental temperature before acquisition of the Data a and the Data b and a second temperature measurement step of measuring the environmental temperature after acquisition of the Data a and the Data b, and

when the temperatures measured by the first temperature measurement step and the second temperature measurement step are indicated as a first temperature and a second temperature, respectively,

i) when the first temperature and the second temperature satisfy the following relational expression (1);

a predetermined value of temperature≦

|(Second Temperature)−

(First Temperature)| 

 

(1),

the method further comprising a step of determining the concentration of the analyte in the blood sample to be evaluated, with the concentration having been corrected according to the temperature of the blood sample based on the Data a and the Data b with reference to a conversion table,

wherein the conversion table is established using a relationship where the amount of electric current that flows in a blood sample due to the reaction involving the oxidoreductase with the analyte used as a substrate varies in the same manner as the amount of electric current that flows in a blood sample according to oxidation or reduction of a redox substance other than the analyte, when the temperature of the blood sample varies, and

in the conversion table, Data c, Data d, and the concentration of the analyte in a reference blood sample corresponding to the Data c and the Data d are described, where the Data c is related to the amount of electric current that flows in the reference blood sample due to the reaction involving the oxidoreductase with the analyte used as a substrate and the Data d is related to the amount of electric current that flows in the reference blood sample according to oxidation or reduction of a redox substance other than the analyte, and

ii) when the first temperature and the second temperature satisfy the following relational expression (2);

|(Second Temperature)−

(First Temperature)|<

a predetermined temperature value 

 

(2),

the method further comprising a step of determining the concentration of the analyte in the blood sample to be evaluated, with the concentration having been corrected according to the temperature of the blood sample based on the Data a and data related to the first temperature and/or the second temperature instead of the Data b with reference to another conversion table, and

the another conversion table has the Data c and Data e for correcting the Data c according to the temperature of a measurement environment.

9. The method according to claim 8, wherein the second temperature measurement step is carried out after a lapse of at least 5 seconds from the first temperature measurement step.

11. The method according to claim 8, wherein the predetermined temperature value is 2.5°

C.

12. 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 into which a blood sample to be evaluated is introduced,

wherein the sensor chip comprises;

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

a measurement part B that acquires, from the blood sample, Data b, related to an amount of electric current that flows in the blood sample according to oxidation or reduction of a redox substance other than the analyte, which is a reaction in which the oxidoreductase is not involved, for temperature correction of the Data a,

a conversion table is stored in the operation part,

a plurality of data is described in the conversion table in such a manner that one converted value based on Data c and Data d, and an concentration of the analyte in a reference blood sample corresponding to the one converted value are related to each other,

the Data c is related to an amount of electric current that flows in the reference blood sample, whose analyte concentration is known and whose temperature is fixed at one value, due to the reaction in which the oxidoreductase with the analyte in the reference blood sample used as a substrate is involved,

the Data d is related to an amount of electric current that flows in the reference blood sample according to oxidation or reduction of a redox substance other than the analyte in the reference blood sample, which is a reaction in which the oxidoreductase is not involved, and

the operation part is programmed to;

calculate another converted value that is based on the Data a and the Data b and corresponds to the one converted value based on the Data c and the Data d,

choose the one converted value that coincides or approximates the calculated another converted value,

read out the concentration of the analyte in the reference blood sample corresponding to the chosen one converted value, and

determine the concentration of the analyte in the blood sample to be evaluated, with the concentration having been corrected according to a temperature of the blood sample, based on the read concentration of the analyte in the reference blood sample.

13. The biosensor system according to claim 12, wherein

i) the operation part determines that the concentration of the analyte in the blood sample to be evaluated equals to the read concentration of the analyte in the reference blood sample, when the chosen one converted value coincides the another converted value, and

ii) the operation part calculates the concentration of the analyte in the blood sample to be evaluated based on the read concentration of the analyte in the reference blood sample, when the chosen one converted value approximates the another converted value.

14. The biosensor system according to claim 12, wherein the one converted value is a divided value of the Data d by a value of the Data c, and

the operation part calculates the another converted value through dividing a value of the Data b by a value of the Data a.