Analyte test sensor and method of manufacturing the same

• US 8,834,690 B2
• Filed: 07/18/2008
• Issued: 09/16/2014
• Est. Priority Date: 12/29/2004
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Laboratories
• Inventors: Ghesquiere, Alexander G., Tonks, Simon
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): ROSENWALD, STEVEN ERIC
• Application Number:
  US12/176,066
• Publication Number:
  US 20090014327A1
• Time in Patent Office: 2,251 Days
• Field of Search: 20440301-40315
• US Class Current: 204/403.01
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/04 by investigating resistance
• 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 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence
• CPC Class Codes: G01N 27/4175 Calibrating or checking the analyser
• CPC Class Codes: G01N 31/00 Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

An analyte test sensor for use in measuring the concentration of a particular analyte in a test sample includes a non-conductive substrate, a reference electrode deposited on the substrate, a working electrode deposited on the substrate and a compensation electrode deposited on the substrate. The compensation electrode is provided with a resistive ladder and is designed to correct for test result inaccuracies which are the result of variances in the manufacturing of the test sensor. Specifically, in one embodiment, the compensation electrode corrects for test result inaccuracies in an analog manner by shunting a portion of the working current away from working electrode. In another embodiment, the compensation electrode corrects for test result inaccuracies in a digital manner by providing a calibration code which is proportional its resistance value. A batch of analyte test sensors are preferably manufactured in the following manner. An initial batch of the test sensors is constructed. Then, a limited sampling of the sensors is tested for accuracy using a control sample. Based on the test results, the resistance value of the compensation electrode for each remaining sensor in the batch is adjusted accordingly.

Claims

1. A method of making a plurality of calibration-adjusted sensors, the method comprising:

applying a known voltage to an electrode pair of a first sensor to produce a working current through the electrode pair of the first sensor;

measuring the working current of the first sensor in the presence of a control sample;

assigning a calibration code to the measured working current of the first sensor; and

modifying the resistance of an electrode pair of a second sensor;

measuring a working current of the second sensor in the presence of a control sample to confirm that when the known voltage is applied to the electrode pair of the second sensor, the second sensor will have a working current that is the same as the working current of the first sensor.

2. The method of claim 1, further comprising:

modifying the resistance of an electrode pair of a third sensor so that when the known voltage is applied to the electrode pair of the third sensor, the third sensor will have a working current that is the same as the working current of the first and second sensors.

3. The method of claim 1, wherein the plurality of sensors is manufactured as part of a common batch and each sensor comprises:

a first substrate having a working electrode thereon; and

an insulation layer over the first substrate.

4. The method of claim 1, wherein modifying the resistance of the electrode pair of the second sensor comprises modifying an electrode configuration.

5. The method according to claim 1, wherein the electrode pair of the second sensor comprises a resistive ladder, and wherein modifying the resistance of the electrode pair comprises ablating a portion of the resistive ladder.

6. The method according to claim 1, wherein an electrode of the second sensor is a working electrode.

7. The method according to claim 1, wherein an electrode of the second sensor is a compensation electrode.

8. The method according to claim 1, wherein the first and second sensors are from different manufacturing batches.

9. A method of making a plurality of calibration-adjusted sensors, the method comprising:

determining a target calibration parameter value for a first sensor;

applying a known voltage to an electrode pair of the first sensor from a first batch of sensors to produce a working current through the electrode pair of the first sensor;

measuring the working current of the first sensor in the presence of a control sample;

modifying the resistance of an electrode pair of a second sensor from the first batch of sensors;

measuring a working current of the second sensor in the presence of a control sample to confirm that when the known voltage is applied to the electrode pair of the second sensor, the second sensor will have a working current that corresponds to the target calibration parameter value.

10. The method according to claim 9, further comprising:

applying a known voltage to an electrode pair of a first sensor from a second batch of sensors to produce a working current through the electrode pair of the first sensor;

measuring the working current of the first sensor from the second batch of sensors; and

modifying the resistance of an electrode pair of a second sensor from the second batch of sensors so that when the known voltage is applied to the electrode pair of the second sensor, the second sensor will have a working current that corresponds to the target calibration parameter value.

11. The method of claim 9, wherein modifying the resistance of the electrode pair comprises modifying an electrode configuration.

12. The method according to claim 9, wherein the electrode pair of the second sensor from the first batch of sensors comprises a resistive ladder, and wherein modifying the resistance of the electrode pair comprises ablating a portion of the resistive ladder.

13. The method according to claim 9, wherein the electrode pair that is modified comprises a working electrode.

14. The method according to claim 9, wherein the electrode pair that is modified comprises a compensation electrode.

15. The method according to claim 10, wherein the electrode pair of the second sensor from the second batch of sensors comprises a resistive ladder, and wherein modifying the resistance of the electrode pair comprises ablating a portion of the resistive ladder.

16. The method according to claim 10, wherein the electrode that is modified comprises a working electrode.

17. The method according to claim 10, wherein the electrode that is modified comprises a compensation electrode.

18. The method according to claim 10, wherein the first batch of sensors and the second batch of sensors are different manufacturing batches.