ANALYTE DETERMINATION METHODS AND DEVICES

• US 20090000959A1
• Filed: 05/29/2008
• Published: 01/01/2009
• Est. Priority Date: 05/31/2007
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Tran, Lam, Wang, Yi, Feldman, Benjamin J., Chen, Ting
• Granted Patent: US 8,080,153 B2
• Time in Patent Office: Days
• US Class Current: 205/777.500
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: C12Q 1/54 involving glucose or galactose

Abstract

The present invention provides methods and apparatuses for analyte detection.

Claims

1. A method of determining a hematocrit-corrected value, the method comprising:

contacting a test strip with a sample that includes an analyte;

determining the fill time of the sample on the test strip; and

determining a hematocrit-corrected value of the analyte using the determined fill time.

2. The method of claim 1, comprising determining the hematocrit-corrected value of an analyte in a sample of blood.

3. The method of claim 2, comprising determining a hematocrit-corrected value of glucose.

4. The method of claim 1, comprising determining the fill time of the sample on the test strip using a coulometric method.

5. The method of claim 1, comprising determining the fill time of the sample on the test strip using an amperometric method.

6. The method of claim 1, wherein the test strip is adapted to provide a result using less than about 1 microliter or less of sample.

7. The method of claim 1, comprising configuring the test strip with one working electrode and one counter-reference electrode.

8. The method of claim 7, further comprising dividing the working electrode or the counter-reference electrode into two independent sub-electrodes:

a first sub-electrode and a second sub-electrode.

9. The method of claim 8, comprising determining the fill time of the test strip by calculating the time for the sample to travel between the first sub-electrode and the second sub-electrode.

10. The method of claim 7, further comprising dividing the working electrode or the counter-reference electrode into three independent sub-electrodes:

a first sub-electrode, a second sub-electrode, and a thirst sub-electrode.

11. The method of claim 10, comprising determining three different fill times on the test strip, wherein a first fill time is calculated between the first sub-electrode and the second sub-electrode, a second fill time is calculated between the second sub-electrode and the third sub-electrode, and wherein a third fill time is calculated between the first sub-electrode and the third sub-electrode.

17. The system of claim 11, wherein the meter uses a coulometric method to calculate the hematocrit-corrected value of the analyte.

18. The system of claim 11, wherein the meter uses a amperometric method to calculate the hematocrit-corrected value of the analyte.

19. The system of claim 18, wherein the test strip further comprises a working electrode and a counter-reference electrode, and wherein the working electrode or the counter-reference electrode is divided into at least two independent sub-electrodes.

20. The system of claim 19, wherein the at least three independent sub-electrodes measure the time required for a sample to move across the test strip from a first sub-electrode to a second sub-electrode, thereby calculating a fill time.

12. A method for correcting the effect of hematocrit on blood glucose measurements, comprising:

filling an electrochemical test strip with a blood sample to be measured;

wherein the test strip is configured to determine the fill time using electrochemical current measurements;

measuring the fill time of the sample on the test strip;

determining an initial blood glucose concentration of the sample; and

calculating a corrected blood glucose concentration of the sample to correct for the effect of hematocrit upon blood glucose measurements by using the fill time to estimate the hematocrit.

13. A system to determine a hematocrit-corrected value of an analyte, the system comprising:

a test strip for contacting a sample;

a meter adapted to receive the test strip, determine a sample fill time of the test strip and determine a hematocrit-corrected value using the determined fill time.

14. The system of claim 13, wherein the analyte is glucose.

15. The system of claim 14, wherein the sample is blood.

16. The system of claim 15, wherein the system is adapted to provide a hematocrit-corrected value using about 1 microliter or less of the sample.

21. A method of determining a whether a sample is a control solution, the method comprising:

contacting a test strip with a sample that includes an analyte;

determining the fill time of the sample on the test strip; and

determining whether a sample is a control solution using the determined fill time.

22. The method of claim 21, comprising determining the fill time of the sample on the test strip using a coulometric method.

23. The method of claim 21, comprising determining the fill time of the sample on the test strip using an amperometric method.

24. The method of claim 21, wherein the test strip is adapted to provide a result using less than about 1 microliter or less of sample.

25. The method of claim 21, comprising configuring the test strip with one working electrode and one counter-reference electrode.

26. The method of claim 25, further comprising dividing the working electrode or the counter-reference electrode into two independent sub-electrodes:

a first sub-electrode and a second sub-electrode.

27. The method of claim 26, comprising determining the fill time of the test strip by calculating the time for the sample to travel between the first sub-electrode and the second sub-electrode.

28. The method of claim 25, further comprising dividing the working electrode or the counter-reference electrode into three independent sub-electrodes:

a first sub-electrode, a second sub-electrode, and a thirst sub-electrode.

29. The method of claim 28, comprising determining three different fill times on the test strip, wherein a first fill time is calculated between the first sub-electrode and the second sub-electrode, a second fill time is calculated between the second sub-electrode and the third sub-electrode, and wherein a third fill time is calculated between the first sub-electrode and the third sub-electrode.