Quantitative analyzing method and quantitative analyzer using sensor

• US 20050258034A1
• Filed: 01/15/2002
• Published: 11/24/2005
• Est. Priority Date: 01/17/2001
• Status: Active Grant

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Iketaki, Kazuo, Inoue, Yoichi
• Granted Patent: US 7,351,323 B2
• Time in Patent Office: Days
• US Class Current: 204/403.10
• CPC Class Codes: C12Q 1/006 for glucose
• 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

A quantitative analyzing method is provided for electrochemically measuring the concentration of a substance in a sample liquid using a sensor including a reagent layer (30) which contains a reagent for reacting with the substance and to which (30) the sample liquid is introduced, and a first electrode (22) and a second electrode (23) for applying a voltage to the reagent layer (30). The method includes a current measuring step for applying a voltage across the first electrode (22) and the second electrode (23) for measuring current flowing between the first and the second electrodes (22,23), a parameter calculating step for calculating a parameter based on the measured current, and a determining step for determining a state of the sample liquid introduced to the reagent layer (30) based on the parameter and at least one predetermined constant.

Claims

1. A quantitative analyzing method for electrochemically measuring concentration of a substance in a sample liquid using a sensor including a reagent layer which contains a reagent for reacting with the substance and to which the sample liquid is introduced, and a first and a second electrodes for applying a voltage to the reagent layer, the method comprising:

a current measuring step for applying a voltage across the first electrode and the second electrode for measuring current flowing between the first electrode and the second electrode;

a parameter calculating step for calculating a parameter based on the measured current; and

a determining step for determining a state of the sample liquid introduced to the reagent layer based on the parameter and at least one predetermined constant.

2. A quantitative analyzing method for electrochemically measuring concentration of a substance in a sample liquid using a sensor including a reagent layer which contains a reagent for reacting with the substance and to which the sample liquid is introduced, and a first and a second electrodes for applying a voltage to the reagent layer, the method comprising:

a current measuring step for applying a voltage across the first electrode and the second electrode for measuring current flowing between the first electrode and the second electrode;

a parameter calculating step for calculating a parameter based on the measured current; and

a determining step for determining whether or not the sample liquid introduced to the reagent layer is insufficient in amount based on the parameter and at least one predetermined constant.

3. The quantitative analyzing method according to claim 2, wherein the parameter includes a current value of the current flowing between the first electrode and the second electrode at a predetermined point of time.

4. The quantitative analyzing method according to claim 2, wherein the parameter includes a difference between a first current value at a first predetermined point of time and a second current value at a second predetermined point of time of the current flowing between the first electrode and the second electrode.

5. The quantitative analyzing method according to claim 2, wherein the parameter includes a differentiation of the current flowing between the first electrode and the second electrode at a predetermined point of time.

6. The quantitative analyzing method according to claim 2, wherein the parameter includes a third difference between a first value and a second value with respect to the current flowing between the first electrode and the second electrode, the first value being obtained by dividing a current value at a third predetermined point of time by a first difference between a current value at a first predetermined point of time and a current value at a second predetermined point of time, the third point of time being included in a period between the first point of time and the second point of time, the second value being obtained by dividing a current value at a sixth predetermined point of time by a second difference between a current value at a fourth predetermined point of time and a current value at a fifth predetermined point of time, the sixth point of time being included in a period between the fourth point of time and the fifth point of time.

7. The quantitative analyzing method according to claim 2, wherein a series of process steps including the current measuring step, the parameter calculating step and the determining step is repeated a plurality of times, the sample liquid introduced to the reagent layer being finally determined to be insufficient in amount when the sample liquid is determined to be insufficient in every determining step.

8. The quantitative analyzing method according to claim 2, wherein the current measuring step is continued for a first period from before to after a point of time when the introduction of the sample liquid to the reagent layer is detected based on the current flowing between the first electrode and the second electrode, at least a part of the parameter being calculated based on the current measured in the first period.

9. The quantitative analyzing method according to claim 7, wherein the series of process steps including the current measuring step, the parameter calculating step and the determining step is repeated an optional number of times after the sample liquid is introduced to the reagent layer and before and/or after a second period during which current is not substantially caused to flow between the first electrode and the second electrode.

10. The quantitative analyzing method according to claim 2, wherein at least part of said at least one constant is varied depending on a temperature of the sample liquid.

11. A quantitative analyzer for electrochemically measuring concentration of a substance in a sample liquid using a sensor including a reagent layer which contains a reagent for reacting with the substance and to which the sample liquid is introduced, and a first and a second electrodes for applying a voltage to the reagent layer, comprising:

voltage applying means for applying a voltage across the first electrode and the second electrode;

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

calculating means for calculating a parameter based on the measurement obtained by the current measuring means; and

determining means for determining a state of the sample liquid introduced to the reagent layer based on the parameter obtained by the calculating means and at least one predetermined constant.

12. A quantitative analyzer for electrochemically measuring concentration of a substance in a sample liquid using a sensor including a reagent layer which contains a reagent for reacting with the substance and to which the sample liquid is introduced, and a first and a second electrodes for applying a voltage to the reagent layer, comprising:

voltage applying means for applying a voltage across the first electrode and the second electrode;

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

calculating means for calculating a parameter based on the measurement obtained by the current measuring means; and

determining means for determining whether or not the sample liquid introduced to the reagent layer is insufficient in amount based on the parameter calculated by the calculating means and at least one predetermined constant.

13. The quantitative analyzer according to claim 12, wherein the calculating means calculates a current value of the current flowing between the first electrode and the second electrode at a predetermined point of time as at least a part of the parameter.

14. The quantitative analyzer according to claim 12, wherein the calculating means calculates a difference between a current value at a first predetermined point of time and a current value at a second predetermined point of time of the current flowing between the first electrode and the second electrode as at least a part of the parameter.

15. The quantitative analyzer according to claim 12, wherein the calculating means calculates a differentiation of the current flowing between the first electrode and the second electrode at a predetermined point of time as at least a part of the parameter.

16. The quantitative analyzer according to claim 12, wherein the calculating means calculates, as at least a part of the parameter, a third difference between a first value and a second value with respect to the current flowing between the first electrode and the second electrode, the first value being obtained by dividing a current value at a third predetermined point of time by a first difference between a current value at a first predetermined point of time and a current value at a second predetermined point of time, the third point of time being included in a period between the first point of time and the second point of time, the second value being obtained by dividing a current value at a sixth predetermined point of time by a second difference between a current value at a fourth predetermined point of time and a current value at a fifth predetermined point of time, the sixth point of time being included in a period between the fourth point of time and the fifth point of time.

17. The quantitative analyzer according to claim 12, wherein a combination of operations performed by the current measuring means, the calculating means and the determining means is repeated a plurality of times, the sample liquid introduced to the reagent layer being finally determined to be insufficient in amount when the determining means determines that the sample liquid is insufficient at every repetition of the combined operations.

18. The quantitative analyzer according to claim 12, wherein the current measuring means operates for a first period from before to after a point of time when the introduction of the sample liquid to the reagent layer is detected based on the current flowing between the first electrode and the second electrode, the calculating means calculating at least a part of the parameter based on the current measured in the first period.

19. The quantitative analyzer according to claim 12, wherein a combination of operations performed by the current measuring means, the calculating means and the determining means is repeated an optional number of times after the sample liquid is introduced to the reagent layer and before and/or after a second period during which current is not substantially caused to flow between the first electrode and the second electrode.

20. The quantitative analyzer according to claim 19, wherein the determining means varies at least part of said at least one constant depending on a temperature of the sample liquid.

21. A quantitative analyzing method for electrochemically measuring concentration of a substance in a sample liquid using a sensor including a reagent layer which contains a reagent for reacting with the substance and to which the sample liquid is introduced, and a first and a second electrodes for applying a voltage to the reagent layer, the method comprising:

a first current measuring step for applying a voltage across the first electrode and the second electrode for a first period for measuring current flowing between the first electrode and the second electrode;

a sample liquid introducing step for introducing the sample liquid to the reagent layer within the first period;

a first parameter calculating step for calculating a parameter based on the current measured in the first current measuring step;

a first determining step for determining whether or not the sample liquid introduced to the reagent layer is insufficient in amount based on the parameter obtained in the first parameter calculating step and at least one first constant determined in advance;

a reaction promoting step for substantially intermitting voltage application across the first electrode and the second electrode for a second period;

a second current measuring step for applying a voltage across the first electrode and the second electrode for a third period for measuring current flowing between the first electrode and the second electrode;

a second parameter calculating step for calculating a parameter based on the current measured in the second current measuring step; and

a second determining step for determining whether or not the sample liquid introduced to the reagent layer is insufficient in amount based on the parameter obtained in the second parameter calculating step and at least one second constant determined in advance.

22. The quantitative analyzing method according to claim 21, wherein a first series of process steps including the first current measuring step, the first parameter calculating step and the first determining step and/or a second series of process steps including the second current measuring step, the second parameter calculating step and the second determining step are repeated respectively a plurality of times, the sample liquid introduced to the reagent layer being finally determined to be insufficient in amount when the sample liquid is determined to be insufficient in every first determining step in the first series of process steps or in every second determining step in the second series of process steps.