Method and apparatus for electrochemical measurement using statistical technique

• US 6,576,117 B1
• Filed: 01/29/2001
• Issued: 06/10/2003
• Est. Priority Date: 05/20/1998
• Status: Expired due to Fees

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Hamamoto, Katsumi, Iketaki, Kazuo, Inoue, Yoichi
• Primary Examiner(s): Warden, Sr., Robert J.
• Assistant Examiner(s): Olsen, Kaj K.
• Application Number:
  US09/700,765
• Time in Patent Office: 862 Days
• Field of Search: 204/400, 204/403, 204/408, 204/403.01, 204/403.11, 205/777.5, 702/99, 702/104
• US Class Current: 205/777.5
• CPC Class Codes: G01K 7/00 Measuring temperature based on the use of electric or magnetic elements directly sensitive to heat giving results other than momentary value of temperature G01K3/00 ; Power supply therefor, e.g. using thermoelectric elements
• 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 predetermined voltage is applied to a biosensor twice to promote an electrochemical reaction, and the following parameters (P1 and P2) are calculated from the values of detected current. A statistical technique is used with these parameters to compensate for errors so that the concentration of an object can be determined. P1: the ratio (If/Ib) of the maximum current (If) or a current occurring the maximum in the first excitation to a current (Ib) read at any point in the second excitation. P2: a current (Ib) read at any point in the second excitation.

Claims

1. An electrochemical measurement method to measure a concentration of an analyte in a sample by using a biosensor, wherein the concentration of the analyte is obtained by providing a sample to the biosensor, applying first and second predetermined voltages to the biosensor to which the sample has been provided, calculating parameters P1 and P2 from current values that are obtained as a result of applying a fixed voltage to the biosensor, and by correcting the errors from these parameters by a statistical technique, where

P1:

a ratio (If/Ib), where (If) is the value of maximum current or a current occurring after the maximum in a first excitation caused by applying the first predetermined voltage, and (Ib) is the value of current read at any point in a second excitation caused by applying the second predetermined voltage;

P2;

a current (Ib) read at any point in the second excitation caused by applying the second predetermined voltage, and

determining the analyte concentration using the parameters P1 and P2.

2. The measurement method according to claim 1, wherein the current value Ib at any point in the second excitation used for the parameters P1 and P2 is a terminal value (Ib(β

)) in the second excitation current.

3. The measurement method according to claim 1, wherein at least one of parameters P3 and P4 is used together with the parameters P1 and P2, where P3:

a value (I/Δ

I(δ

)) obtained by normalizing a derivative value or a differential value at any point in the second excitation with a current value at the same point; and

P4;

a ratio (Ib(α

)/Ib(β

)) of an initial current value (Ib(α

)) to a terminal current value (Ib(β

)) in a second excitation.

4. The measurement according to claim 3, wherein at least one of the parameters P3 and P4 is substituted with a closest expectation value when the parameter is out of an expectation range.

5. The measurement method according to claim 1, including measuring an environmental temperature or a sample temperature, wherein a correction is performed in accordance with the environmental temperature or the sample temperature by preparing a plurality of correction formulas using a statistical technique corresponding to the environmental temperature or the sample temperature and by selecting an optimum correction formula from the plural correction formulas.

6. The measurement method according to claim 5, wherein the concentration of the analyte in the sample is obtained when the environmental temperature or the sample temperature corresponds to a boundary region of the temperature range used for a correction formula, by selecting both correction formulas adjacent to a boundary, calculating correction ranges from the respective formulas, adding average values or weighted average values to the current value for concentration conversion, and obtaining the concentration depending on an additional value.

7. The measurement method according to claim 1, wherein a discriminant function is selected from the parameters.

8. The measurement according to claim 7, wherein a discriminant score is obtained from the discriminant function and the concentration of the analyte is calculated from a correction range proportional to the discriminant score.

9. The measurement method according to claim 7, wherein a range to calculate the concentration of the analyte depending on a fixed correction range regardless of the discriminant score, and a range to calculate the concentration of the analyte without performing a correction, are set.

10. A measurement apparatus comprising a meter for measuring an environmental temperature or a sample temperature, a detector for detecting sample feeding, a device for applying a certain voltage to a biosensor at a predetermined point of time, a meter for measuring a value of current generated by an electrochemical reaction, and a converter for converting the measured value of the current into a concentration of the analyte in the sample;

including means for measuring the concentration of an analyte, means for feeding a sample, means for applying first and second predetermined voltages to the biosensor after sample feeding, means for calculating parameters P1 and P2 from current values that are obtained as a result of applying a fixed voltage to the biosensor, and means for correcting errors of a measured value using these parameters by a statistical technique, where

P1;

a ratio (If/Ib), where (If) is the value of maximum current or a current occurring after the maximum in a first excitation caused by applying the first predetermined voltage, and (Ib) is the value of current read at any point in a second excitation caused by applying a second predetermined voltage after the first predetermined voltage;

P2;

a current (Ib) read at any point in the second excitation caused by applying the second predetermined voltage.