Electrochemical analyte measurement method and system

• US 8,962,270 B2
• Filed: 03/30/2011
• Issued: 02/24/2015
• Est. Priority Date: 03/31/2010
• Status: Expired due to Fees

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Malecha, Michael, Craggs, Adam
• Primary Examiner(s): Weber, Jon P
• Assistant Examiner(s): Knight, Teresa E
• Application Number:
  US13/637,220
• Publication Number:
  US 20130095510A1
• Time in Patent Office: 1,427 Days
• Field of Search: None
• US Class Current: 435/14
• 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 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• 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 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G16B 99/00 Subject matter not provided for in other groups of this subclass

Abstract

Described and illustrated herein are systems and exemplary methods of operating an analyte measurement system having a meter and a test strip. In one embodiment, the method may be achieved by applying a first test voltage between a reference electrode and a second working electrode and applying a second test voltage between the reference electrode and a first working electrode; measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample containing an analyte is applied to the test strip; measuring a fifth test current at the first working electrode; estimating a hematocrit-corrected analyte concentration from the first, second, third, fourth and fifth test currents; and annunciating the hematocrit-corrected analyte concentration.

Claims

1. A method for determining a glucose concentration measurable with a system having a test strip and a meter having a test circuit including a microprocessor, the method comprising:

applying, with the test circuit, a first test voltage between a reference electrode and a second working electrode coated with a reagent layer of the test strip and applying a second test voltage between the reference electrode and a first working electrode coated with a reagent layer;

measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample is applied to the test strip;

measuring a fifth test current at the first working electrode;

determining, with the microprocessor, a glucose concentration based on the first, second, third, fourth and fifth test currents; and

annunciating the glucose concentration, in which the glucose concentration comprises a value obtained with an equation of the form;

2. The method of claim 1, in which the reference electrode, the first electrode and the second electrodes are disposed on a single plane.

3. The method of claim 1, in which the first test current is measured from about 0.98 to about 1.00 seconds after initiation of the measuring.

4. The method of claim 1, in which the second current is measured from about 1.98 to about 2.00 seconds after initiation of the measuring.

5. The method of claim 1, in which the third current is measured from about 2.43 to about 2.45 seconds after initiation of the measuring.

6. The method of claim 1, in which the fourth current is measured from about 2.61 to about 2.63 seconds after initiation of the measuring.

7. The method of claim 1, in which the fifth current is measured from about 2.70 to about 2.72 seconds after initiation of the measuring.

8. The method of claim 1, in which the first test current is measured from about 3.37 to about 3.39 seconds after a reaction period of time.

9. The method of claim 1, in which the second current is measured from about 3.46 to about 3.48 seconds after a reaction period of time.

10. The method of claim 1, in which the third current is measured from about 3.54 to about 3.56 seconds after a reaction period of time.

11. The method of claim 1, in which the fourth current is measured from about 4.05 to about 4.07 seconds after a reaction period of time.

12. The method of claim 1, in which the fifth current is measured from about 4.08 to about 4.10 seconds after a reaction period of time.

13. The method of claim 1, in which first tuning parameter is from about 9.9 to about 10.2 and second tuning parameter is from about 10.8 to about 11.2.