Biosensor calibration method

• US 8,975,080 B2
• Filed: 03/14/2013
• Issued: 03/10/2015
• Est. Priority Date: 09/14/2012
• Status: Active Grant

• Current Assignee: Tanita Corporation (Tanita)
• Original Assignee: Tanita Corporation (Tanita)
• Inventors: Kose, Mariko, Murayama, Tatsuro, Kinoshita, Yuri, Ikeda, Satoshi
• Primary Examiner(s): Wallenhorst, Maureen
• Application Number:
  US13/804,937
• Publication Number:
  US 20140080167A1
• Time in Patent Office: 726 Days
• Field of Search: 436/8, 436/14, 436/63, 436/95, 436/149, 436/150, 435/14, 435/25, 73/10.1, 73/10.2, 73/10.3, 702/100
• US Class Current: 436/8
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• 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: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A biosensor calibration method configured to measure a concentration of a specific substance contained in sample liquid to be measured, including: a first step configured to acquire a first output value that is output by the biosensor when first calibration liquid is brought into contact with the biosensor; a second step configured to acquire a second output value that is output by the biosensor when second calibration liquid having a different concentration from that of the first calibration liquid is continuously brought into contact with the biosensor after the first step and determine time for replacement of the biosensor on the basis of the first output value and the second output value.

Claims

1. A biosensor calibration method, wherein a biosensor is configured to measure a concentration of a specific substance contained in sample liquid to be measured, the method comprising:

(a) measuring a base output value in a state in which the biosensor is covered with a cap and the biosensor is in contact with a storage liquid that is filled in an interior of the cap;

(b) acquiring a first output value that is output by the biosensor when first calibration liquid is brought into contact with the biosensor in a state in which the cap is removed from the biosensor, the first output value being obtained by subtracting the base output value from an actual measured value output by the biosensor;

(c) acquiring a second output value that is output by the biosensor when second calibration liquid having a different concentration of the specific substance from that of the first calibration liquid is brought into contact with the biosensor after the step (b) without performing a cleaning operation, the second output value being obtained by subtracting the base output value from an actual measured value output by the biosensor; and

(d) determining whether or not the time for replacement of the biosensor has been reached on the basis of whether or not the first output value and the second output value satisfy a predetermined relationship based on a concentration ratio of the first calibration liquid and the second calibration liquid.

2. The biosensor calibration method according to claim 1, wherein the concentration of the second calibration liquid is higher than the concentration of the first calibration liquid.

3. The biosensor calibration method according to claim 1, wherein the second calibration liquid has a concentration twice to six times that of the first calibration liquid.

4. The biosensor calibration method according to claim 1, wherein the predetermined relationship is defined by

(first output value×

n)×

(1−

0.35)≦

second output value≦

(first output value×

n)×

(1+0.05)

(where, n=concentration of the second calibration liquid/concentration of the first calibration liquid).

5. The biosensor calibration method according to claim 1, further comprising a step of cleaning the biosensor after the step (c).

6. The biosensor calibration method according to claim 1, further comprising a first notifying step of encouraging a user to bring the second calibration liquid into contact with the biosensor from 6 seconds to 20 seconds after the contact of the first calibration liquid.

7. The biosensor calibration method according to claim 6, further comprising a second notifying step of encouraging the user to clean the biosensor from 6 seconds to 20 seconds after the contact of the second calibration liquid.

8. The biosensor calibration method according to claim 1, wherein the step (a) comprises determining whether or not the base output value is within a range of a predetermined defined value.

9. The biosensor calibration method according to claim 1, wherein the step (b) comprises determining whether or not the first output value is within a predetermined range.

10. The biosensor calibration method according to claim 1, wherein the step (a) comprising immersing the biosensor in the storage liquid that does not contain the specific substance.

11. The biosensor calibration method according to claim 1, further comprising:

(e) executing an untreated error processing to prevent the biosensor from being destroyed if a predetermined operation is not performed within a predetermined time; and

(f) executing an error processing to encourage a user to execute cleaning and/or calibration of the biosensor.

12. A biochemical instrument comprising:

a biosensor configured to measure a concentration of a specific substance contained in sample liquid to be measured;

a cap; and

a controller configured to perform the steps of;

(a) measuring a base output value in a state in which the biosensor is covered with the cap and the biosensor is in contact with a storage liquid that is filled in an interior of the cap;

(b) acquiring a first output value that is output by the biosensor when first calibration liquid is brought into contact with the biosensor in a state in which the cap is removed from the biosensor, the first output value being obtained by subtracting the base output value from an actual measured value output by the biosensor;

(c) acquiring a second output value that is output by the biosensor when second calibration liquid having a different concentration of the specific substance from that of the first calibration liquid is brought into contact with the biosensor after the step (b) without performing a cleaning operation, the second output value being obtained by subtracting the base output value from an actual measured value output by the biosensor; and

(d) determining whether or not the time for replacement of the biosensor has been reached on the basis of whether or not the first output value and the second output value satisfy a predetermined relationship based on a concentration ratio of the first calibration liquid and the second calibration liquid.

13. A biochemical instrument comprising:

a biosensor configured to measure a concentration of a specific substance contained in sample liquid to be measured; and

a controller configured to perform the steps of;

(a) acquiring a first output value that is output by the biosensor when first calibration liquid is brought into contact with the biosensor;

(b) acquiring a second output value that is output by the biosensor when second calibration liquid having a different concentration of the specific substance from that of the first calibration liquid is brought into contact with the biosensor after the step (a) without performing a cleaning operation; and

(c) determining whether or not the time for replacement of the biosensor has been reached on the basis of whether or not the first output value and the second output value satisfy the relationship of;

(first output value×

n)×

(1−

0.35)≦

second output value≦

(first output value×

n)×

(1+0.05)

(where, n=concentration of the second calibration liquid/concentration of the first calibration liquid).