Analyte test sensor and method of manufacturing the same

• US 7,418,285 B2
• Filed: 12/29/2004
• Issued: 08/26/2008
• Est. Priority Date: 12/29/2004
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Ghesquiere, Alexander G., Tonks, Simon
• Primary Examiner(s): Nasser, Jr.; Robert L.
• Assistant Examiner(s): Saidi; Anita
• Application Number:
  US11/025,691
• Publication Number:
  US 20060144704A1
• Time in Patent Office: 1,336 Days
• Field of Search: 600345-350, 204/403.1, 204/403.03, 204/403.04, 204/403.09, 204/403.13, 204/294, 204/412, 204/403.05, 204/403.11, 257/414, 257/253, 702/19, 205/775, 205/777.5, 205/787, 205/792, 604/20
• US Class Current: 600/345
• 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. An analyte test sensor for use in measuring the concentration of a particular analyte in a test sample, the analyte test sensor comprising:

(a) a non-conductive substrate,

(b) a reference electrode on the substrate, the reference electrode comprising a first end and a second end,

(c) a working electrode on the substrate in a spaced apart relationship from the reference electrode, the working electrode comprising a first end and a second end,

(d) an enzyme on the working electrode, the enzyme generating a first current when exposed to the analyte in the test sample, the value of the first current being proportional to the concentration of the analyte in the test sample, and

(d) at least one compensation electrode on the substrate, the compensation electrode comprising a first end and a second end,

(e) wherein the compensation electrode is constructed to correct test result inaccuracies which are the result of variances in the manufacturing of the analyte test sensor.

2. The analyte test sensor of claim 1 wherein the compensation electrode has a variable resistance value.

3. The analyte test sensor of claim 2 wherein the compensation electrode includes a resistive ladder for adjusting its resistance value.

4. The analyte test sensor of claim 2 wherein the compensation electrode is conductively connected to the working electrode.

5. The analyte test sensor of claim 4 wherein the first end of the compensation electrode is conductively connected to the working electrode at a location between its first and second ends.

6. The analyte test sensor of claim 5 wherein the compensation electrode corrects test result inaccuracies which are the result of variances in the manufacturing of the analyte test sensor in an analog manner.

7. The analyte test sensor of claim 6 wherein the first current travels along the working current in the direction towards its second end.

8. The analyte test sensor of claim 7 wherein the compensation electrode shunts a portion of the first current away from the second end of the working electrode.

9. The analyte test sensor of claim 8 wherein the value of the portion of the first current which is shunted away from the second end of the working electrode by the compensation electrode is proportional to the resistance value of the compensation electrode.

10. The analyte test sensor of claim 2 wherein the compensation electrode corrects test result inaccuracies which are the result of variances in the manufacturing of the analyte test sensor in a digital manner.

11. The analyte test sensor of claim 10 wherein the compensation electrode provides a digital calibration code to correct test result inaccuracies which are the result of variances in the manufacturing of the analyte test sensor.

12. The analyte test sensor of claim 11 wherein the value of the digital calibration code is proportional to the resistance value of the compensation electrode.

13. The analyte test sensor of claim 12 wherein the compensation electrode is electrically insulated from the working electrode.

14. An analyte test sensor for use in measuring the concentration of a particular analyte in a test sample, the analyte test sensor comprising:

(a) a reference electrode;

(b) a working electrode in a spaced apart relationship from the reference electrode;

(c) an enzyme on the working electrode; and

(d) a compensation electrode, wherein the compensation electrode is constructed to correct a test result for manufacturing variances of the analyte test sensor.

15. The analyte test sensor of claim 14, wherein the compensation electrode provides digital information to a measuring device to correct test result inaccuracies which are the result of variances in the manufacturing of the analyte test sensor.

16. The analyte test sensor of claim 15 wherein the value of the digital information is proportional to the resistance value of the compensation electrode.

17. The analyte test sensor of claim 14 wherein the compensation electrode has a variable resistance value.

18. The analyte test sensor of claim 14 wherein the compensation electrode includes a resistive ladder for adjusting its resistance value.

19. The analyte test sensor of claim 14 wherein the compensation electrode is conductively connected to the working electrode.

20. The analyte test sensor of claim 14 wherein the compensation electrode shunts a portion of a current away from the working electrode.