Determination method for automatically identifying analyte liquid and standard solution for biosensor

• US 7,504,020 B2
• Filed: 10/31/2003
• Issued: 03/17/2009
• Est. Priority Date: 10/31/2002
• Status: Active Grant

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Corporation (Panasonic Holdings Corporation)
• Inventors: Tokunaga, Hiroyuki, Yamanishi, Eriko, Miyazaki, Shoji, Uchiyama, Motonori
• Primary Examiner(s): Olsen; Kaj K
• Application Number:
  US10/523,076
• Publication Number:
  US 20050247562A1
• Time in Patent Office: 1,964 Days
• Field of Search: 204/403.01, 204/403.02, 204/406, 205/792
• US Class Current: 205/792
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 2496/80 Multi-analyte reference solutions containing cholesterol, glucose and the like
• CPC Class Codes: G01N 33/96 involving blood or serum control standard

Abstract

According to the standard solution and the determination method of the present invention, in a case where a voltage is applied by a drive voltage of a measurement apparatus to an electrode portion of a biosensor comprising an electrode portion including a counter electrode and a measuring electrode formed on an insulating substrate, and a reagent layer which reacts with a sample solution supplied to the electrode portion, and a current value which flows at the application is measured, thereby determining a substrate contained in the sample solution, a reducing substance is contained in the standard solution used for controlling a precision of measurement of the measurement apparatus. Therefore, when the standard solution is measured, a large change occurs in a current waveform between time t0 and t1 shown in FIG. 6 due to the reducing substance, thereby discriminating whether the analyte liquid being measured is the standard solution or the sample solution and easily identifying the kind of analyte liquid.

Claims

1. A method for determining a substrate contained in a sample solution on the basis of an oxidation current value, the method comprising:

applying a first potential from a driving power supply of a measurement apparatus to an electrode portion of a biosensor for a first time period, the biosensor including the electrode portion, which comprises a counter electrode and a measuring electrode, and a reagent layer, which reacts with the sample solution supplied to the electrode portion;

stopping the application of the first potential for a given time period; and

applying a second potential, which is smaller than the first potential, to the electrode portion for a second time period after the given time period has passed;

determining whether a kind of analyte liquid supplied to the biosensor is the sample solution or a standard solution based on the oxidation current value obtained by applying the first potential and the oxidation current value obtained by applying the second potential,

wherein the standard solution is supplied to the electrode portion of the biosensor as the standard solution is used for controlling a precision of measurement of the measurement apparatus,

wherein when the first potential is applied to the electrode portion of the biosensor to which the standard solution is supplied by the driving power supply of the measurement apparatus, the standard solution shows an oxidation current waveform which is definitely different from a waveform which is obtained when the first potential is applied to the electrode portion of the biosensor to which the sample solution is supplied,

wherein when the second potential is applied to the electrode portion of the biosensor to which the standard solution is supplied, the standard solution shows an oxidation current waveform which is approximately the same as a waveform which is obtained when the second potential is applied to the electrode portion of the biosensor to which the sample solution is supplied,

wherein the standard solution is one such that the value of the oxidation current, which flows when the first potential is applied to the electrode portion of the biosensor to which the standard solution is supplied by the driving power supply of the measurement apparatus, is larger than the value of the oxidation current which flows when the second potential is applied, and

wherein the standard solution includes a reducing substance and a predetermined amount of substrate, and the precision of measurement of the measurement apparatus controlled by checking whether a measured substrate concentration is within a predetermined range or not.

2. The determination method as defined in claim 1, wherein,

the determination as to whether a kind of analyte liquid supplied to the biosensor is the sample solution or the standard solution is based on ratios between oxidation current values obtained by applying the first potential and oxidation current values obtained by applying the second potential.

3. The determination method as defined in claim 1, wherein

a discrimination parameter used for the determination is calculated on the basis of the oxidation current value obtained by applying the first potential and the oxidation current value obtained by applying the second potential, a discrimination function employing the discrimination parameter as an independent variable is defined, and a numeric value obtained by substituting the value of the discrimination parameter into the discrimination function is taken as a discrimination index, thereby determining whether the kind of analyte liquid supplied to the biosensor is the sample solution or the standard solution, on the basis of the discrimination index.

4. The determination method as defined in claim 1, wherein

the reducing substance is oxidized when the potential of the measuring electrode is 0.1V to 1.0V higher than that of a reference electrode of Ag/AgCl.

5. A method for determining a substrate contained in a sample solution on the basis of an oxidation current value, the method comprising:

applying a first potential from a driving power supply of a measurement apparatus to an electrode portion of a biosensor for a first time period, the biosensor including the electrode portion, which comprises a counter electrode and a measuring electrode, and a reagent layer, which reacts with the sample solution supplied to the electrode portion;

stopping the application of the first potential for a given time period; and

applying a second potential, which is smaller than the first potential, to the electrode portion for a second time period after the given time period has passed;

determining whether a kind of analyte liquid supplied to the biosensor is the sample solution or a standard solution based on the oxidation current value obtained by applying the first potential and the oxidation current value obtained by applying the second potential,

wherein the standard solution is supplied to the electrode portion of the biosensor as the standard solution is used for controlling a precision of measurement of the measurement apparatus,

wherein the standard solution includes a reducing substance and a predetermined amount of substrate, and the precision of measurement of the measurement apparatus is controlled by checking whether a measured substrate concentration is within a predetermined range or not, and

wherein the reducing substance is at least one of uric acid, bilirubin, ascorbic acid, methylene blue, Bis(2-hydroxyethyl)iminotris(hydroxymethyl)methane, N, N-Bis(2-hydroxyethyl)-2-aminoethanesulfonic acid, and acetaminophen.

6. The determination method as defined in claim 5, wherein the determination as to whether a kind of analyte liquid supplied to the biosensor is the sample solution or the standard solution is based on ratios between oxidation current values obtained by applying the first potential and oxidation current values obtained by applying the second potential.

7. The determination method as defined in claim 5, wherein a discrimination parameter used for the determination is calculated on the basis of the oxidation current value obtained by applying the first potential and the oxidation current value obtained by applying the second potential, a discrimination function employing the discrimination parameter as an independent variable is defined, and a numeric value obtained by substituting the value of the discrimination parameter into the discrimination function is taken as a discrimination index, thereby determining whether the kind of analyte liquid supplied to the biosensor is the sample solution or the standard solution, on the basis of the discrimination index.

8. The determination method as defined in claim 5, wherein the reducing substance is oxidized when the potential of the measuring electrode is 0.1V to 1.0V higher than that of a reference electrode of Ag/AgCl.