Analyte Test Sensor and Method of Manufacturing the Same

• US 20150002171A1
• Filed: 09/16/2014
• Published: 01/01/2015
• Est. Priority Date: 12/29/2004
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Tonks, Simon, Ghesquiere, Alexander G.
• Granted Patent: US 9,535,023 B2
• Time in Patent Office: Days
• US Class Current: 324/601
• 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

1-18. -18. (canceled)

19. 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 from a 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;

determining the working current of the first sensor;

wherein when the working current of the first sensor is not the same as a target working current, modifying the resistance of an electrode pair of a second sensor from the batch of sensors;

measuring the 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 target working current.

20. The method according to claim 19, further comprising:

modifying the resistance of an electrode pair of all the sensors in the batch of sensor such that the all the sensors will have a working current that is the same as the second sensor.

21. The method according to claim 19, wherein each sensor of the batch of sensors comprises:

a first substrate having a working electrode thereon; and

an insulation layer over the first substrate.

22. The method according to claim 19, wherein modifying the resistance of the electrode pair of the second sensor comprises modifying an electrode configuration.

23. The method according to claim 19, wherein an electrode of the second sensor is a working electrode.

24. The method according to claim 19, wherein an electrode of the second sensor is a compensation electrode.

25. 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 and determining a calibration parameter for the first sensor;

wherein when the determined calibration parameter of the first sensor is not the same as a target calibration parameter, modifying the resistance of an electrode pair of a second sensor from the 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.

26. The method according to claim 25, further comprising:

modifying the resistance of an electrode pair of all the sensors in the batch of sensor such that the all the sensors will have a working current that is the same as the second sensor.

27. The method according to claim 25, wherein modifying the resistance of the electrode pair comprises modifying an electrode configuration.

28. The method according to claim 25, 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.

29. The method according to claim 25, 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.

30. The method according to claim 25, wherein the electrode pair that is modified comprises a working electrode.

31. The method according to claim 25, wherein the electrode pair that is modified comprises a compensation electrode.