Biosensor, measuring instrument for biosensor, and method of quantifying substrate

• US 7,850,839 B2
• Filed: 03/16/2006
• Issued: 12/14/2010
• Est. Priority Date: 11/30/2000
• Status: Active Grant

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Corporation (Panasonic Holdings Corporation)
• Inventors: Miyazaki, Shoji, Matsumoto, Kazuhiro, Sawada, Yasuhiko, Tokunaga, Hiroyuki, Tokuno, Yoshinobu
• Primary Examiner(s): Olsen; Kaj K
• Application Number:
  US11/378,944
• Publication Number:
  US 20060175207A1
• Time in Patent Office: 1,734 Days
• Field of Search: 204/403.01, 204/403.02, 204/406, 205/777.5, 205/792
• US Class Current: 205/777.5
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/26 by investigating electrochemical variables; by using electrolysis or electrophoresis
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

A method of measuring a quantity of a substrate contained in sample liquid is provided. This method can reduce measurement errors caused by a biosensor. The biosensor includes at least a pair of electrodes on an insulating board and is inserted into a measuring device which includes a supporting section for supporting detachably the biosensor, plural connecting terminals to be coupled to the respective electrodes, and a driving power supply which applies a voltage to the respective electrodes via the connecting terminals. One of the electrodes of the biosensor is connected to the first and second connecting terminals of the measuring device only when the biosensor is inserted into the measuring device in a given direction, and has a structure such that the electrode becomes conductive between the first and second connecting terminals due to a voltage application by the driving power supply.

Claims

1. A method of measuring a quantity of a substrate included in a sample liquid, comprising the steps of:

providing a biosensor which includes;

an insulating board;

an electrode section formed on at least a part of the insulating board, the electrode section including a counter electrode, a measuring electrode, and a detecting electrode;

a sample supplying path for supplying the sample liquid to the electrode section; and

a reagent layer for reacting with the sample liquid supplied through the sample supplying path, wherein the detecting electrode is disposed most downstream among the counter electrode, the measuring electrode, and the detecting electrode along the sample supplying path from an inlet along a direction of flow of the sample liquid;

providing a measuring device which includes;

a supporting section for detachably supporting the biosensor; and

a connecting terminal and a driving power supply for applying a voltage to the electrode section;

inserting the biosensor into the supporting section of the measuring device;

applying a voltage with the driving power supply to a first group including the counter electrode and the measuring electrode; and

applying a voltage with the driving power supply to a second group including the detecting electrode and one of the measuring electrode and the counter electrode; and

determining whether or not the sample liquid is supplied sufficiently for measurement depending on whether or not respective electric currents supplied from the first and second groups exceed respective predetermined thresholds.

2. The method of claim 1, wherein said step of determining whether or not the sample liquid is supplied sufficiently comprises the sub-step of:

determining that the sample liquid is insufficient when the electric current from the second group does not exceed the predetermined threshold within a given lapse of time since the electric current from the first group exceeds the predetermined threshold.

3. The method of claim 2, further comprising the step of:

when it is determined that the sample liquid is insufficient, outputting the determination to outside of the measuring device.

4. The method of claim 1, further comprising the step of:

halting steps of measuring in order to add the sample liquid when the electric current from the second group does not exceed the predetermined threshold within a given lapse of time since the electric current from the first group exceeds the predetermined threshold.

5. The method of claim 1, wherein an air hole is provided more downstream than the detecting electrode for accelerating the flow of the sample liquid, said method further comprising the step of:

determining that the sample liquid is sucked from the air hole by mistake when the electric current from the second group exceeds the predetermined threshold before the electric current from the first group exceeds the predetermined threshold and when the electric current from the first group does not exceed the predetermined threshold within a given lapse of time.

6. The method of claim 1, further comprising the step of:

compensating a measured quantity of the substrate corresponding to an electric current detected at the electrode section depending on a lapse of time since the electric current from the first group exceeds the predetermined threshold until the electric current from the second group exceeds the predetermined threshold.

7. The method of claim 6, wherein the measuring device further includes a memory for storing calibration data indicating correspondence between an electric current detected at the biosensor and a quantity of the substrate in the sample liquid, said method further comprising the step of:

determining a quantity of the substrate corresponding to the detected electric current referring to the calibration data stored in the memory.

8. The method of claim 1, further comprising the step of:

incubating reaction between the sample liquid and the reagent layer after the sample liquid is supplied to the sample supplying path; and

varying a time for said step of incubating the reaction according to a lapse of time since the electric current from the first group exceeds the predetermined threshold until the electric current from the second group exceeds the predetermined threshold.

9. The method of claim 1, further comprising:

switching the voltage applied to one of the first and second groups at a given interval.