System and method for coding information on a biosensor test strip

• US 7,601,299 B2
• Filed: 04/01/2005
• Issued: 10/13/2009
• Est. Priority Date: 06/18/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Beaty, Terry A., Burke, David W., Celentano, Michael J.
• Primary Examiner(s): Griffin; Walter D
• Assistant Examiner(s): Mui; Christine T
• Application Number:
  US11/097,606
• Publication Number:
  US 20050279647A1
• Time in Patent Office: 1,656 Days
• Field of Search: 422/57, 600/583, 436/514, 435/11, 435/6
• US Class Current: 422/501
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/545 for laboratory containers
• CPC Class Codes: G01N 2035/00851 process control parameters
• 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 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

The present invention provides a test strip for measuring a concentration of an analyte of interest in a biological fluid, wherein the test strip may be encoded with information that can be read by a test meter into which the test strip is inserted.

Claims

1. A method for measuring a concentration of an analyte of interest in a biological fluid, comprising:

providing a test meter;

providing a first test strip, the first test strip comprising;

a first measurement electrode connectable to the test meter,

a first trace loop with a first associated resistance, the first trace loop connectable to the test meter, and

a second trace loop with a second associated resistance, the second trace loop connectable to the test meter;

receiving the first test strip into the test meter;

communicatively connecting the first measurement electrode, the first trace loop, and the second trace loop with the test meter; and

obtaining a first resistance ratio by comparing the first and second associated resistances.

2. The method of claim 1, further comprising:

measuring the first and second associated resistances.

3. The method of claim 1, further comprising:

selecting a predetermined resistance ratio value; and

configuring the ratio of the first associated resistance and the second associated resistance to correlate to the predetermined resistance ratio value.

4. The method of claim 1, further comprising:

determining whether the first resistance ratio correlates to a predetermined value.

5. The method of claim 4, further comprising:

testing the biological fluid for the analyte of interest when the first resistance ratio correlates to the predetermined value.

6. The method of claim 4, further comprising:

inhibiting testing of the biological fluid for the analyte of interest when the first resistance ratio correlates to the predetermined value.

7. The method of claim 4, further comprising:

recording information relating to the first test strip when the first resistance ratio correlates to the predetermined value.

8. The method of claim 1, further comprising:

comparing the first resistance ratio with at least two discrete, non-overlapping ranges, and wherein the first resistance ratio falls within a first one of said discrete ranges.

9. The method of claim 1, wherein the first trace loop comprises a first material and the second trace loop comprises a second material different from the first material.

10. The method of claim 1, wherein:

the first and second associated resistances are different;

the first trace loop comprises a first characteristic length, width, and thickness;

the second trace loop comprises a second characteristic length, width, and thickness; and

at least one of the first characteristic length, width, and thickness differs from a corresponding one of the second characteristic length, width, and thickness.

11. The method of claim 1, wherein the first associated resistance and the second associated resistance correlate to calibration information associated with the first test strip.

12. The method of claim 1, wherein the first test strip further comprises a first measurement electrode trace conductively connected to the first measurement electrode, and wherein the first trace loop comprises at least a portion of the first measurement electrode trace.

13. The method of claim 1, wherein

a portion of the first trace loop comprises a material with first resistive qualities;

and

the remaining portion of the first trace loop comprises a different material with second resistive qualities different from the first resistive qualities.

14. The method of claim 1, further comprising:

providing a second test strip, the second test strip comprising;

a second measurement electrode connectable to the test meter,

a third trace loop with a third associated resistance, the third trace loop connectable to the test meter, and

a fourth trace loop with a fourth associated resistance, the fourth trace loop connectable to the test meter; and

receiving the second test strip into the test meter;

communicatively connecting the second measurement electrode, the third trace loop, and the fourth trace loop with the test meter; and

obtaining a second resistance ratio by comparing the third and fourth associated resistances.

15. The method of claim 14, wherein the first and second resistance ratios are different.

16. The method of claim 14, further comprising:

determining whether said first resistance ratio correlates to a predetermined value, and

determining whether said second resistance ratio correlates to a predetermined value.

17. The method of claim 16, wherein:

testing the biological fluid for the analyte of interest when the first resistance ratio correlates to the predetermined value, and

testing the biological fluid for the analyte of interest when the second resistance ratio correlates to the predetermined value.

18. The method of claim 16, wherein:

inhibiting testing of the biological fluid for the analyte of interest when the first resistance ratio correlates to the predetermined value, and

inhibiting testing of the biological fluid for the analyte of interest when the second resistance ratio correlates to the predetermined value.

19. The method of claim 16, wherein:

recording information relating to the first test strip when the first resistance ratio correlates to the predetermined value, and

recording information relating to the first test strip when the second resistance ratio correlates to the predetermined value.

20. The method of claim 14, wherein:

comparing the first resistance ratio with at least two discrete, non-overlapping ranges, and wherein the first resistance ratio falls within a first one of said discrete ranges, and

comparing the second resistance ratio with the at least two discrete, non-overlapping ranges, and wherein the second resistance ratio falls within a second one of said discrete ranges.

21. The method of claim 14, wherein:

the first associated resistance and the second associated resistance correlate to calibration information associated with the first test strip, and

the third associated resistance and the fourth associated resistance correlate to calibration information associated with the second test strip.

22. The method of claim 14, wherein:

the first and third associated resistances are different;

the first trace loop comprises a first characteristic length, width, and thickness;

the third trace loop comprises a third characteristic length, width, and thickness; and

at least one of the first characteristic length, width, and thickness differs from a corresponding one of the third characteristic length, width, and thickness.

23. The method of claim 14, wherein the first and second test strips further comprise substantially similar mask configurations, wherein:

the first and second measurement electrodes are substantially similar;

the first and third trace loops are substantially similar, each with a gap and a resistive element conductively bridging the gap; and

the second and fourth trace loops are substantially similar, each with a gap and a resistive element conductively bridging the gap.

24. The method of claim 23, wherein each resistive element has an associated resistance, and the associated resistance for the resistive element conductively bridging the gap in the first trace loop is different from the associated resistance for the resistive element conductively bridging the gap in the third trace loop.

25. The method of claim 1,

wherein said providing a first test strip includes a test strip comprising a third trace loop with a third associated resistance, the third trace loop connectable to the test meter;

and

wherein said obtaining includes obtaining a second resistance ratio by comparing the first and third associated resistances.

26. The method of claim 25, further comprising:

determining whether the first resistance ratio correlates to a predetermined value; and

determining whether the second resistance ratio correlates to a predetermine value.

27. A method for encoding information readable by a test meter onto a test strip, the test strip adapted for measuring a concentration of an analyte of interest in a biological fluid, comprising:

selecting a first resistance ratio associated with a first word desired to be encoded on the test strip;

forming a measurement electrode on the surface of the test strip substrate, wherein the measurement electrode is connectable to a test meter; and

forming a first electrical trace and a second electrical trace on the surface of the test strip substrate, wherein the resistance of each of the first and second electrical traces are obtainable by the test meter, and wherein the ratio of the resistance of the first electrical trace and the resistance of the second electrical trace effectively matches the first resistance ratio.

28. The method of claim 27, further comprising:

selecting a second resistance ratio associated with a second word desired to be encoded on the test strip; and

forming a third electrical trace on the surface of the test strip substrate, wherein the resistance of the third electrical trace is obtainable by the test meter, and wherein the ratio of the resistance of the first electrical trace and the resistance of the third electrical trace effectively matches the second resistance ratio.

29. The method of claim 28, wherein the first word is associated with a first discrete range of resistance values, and the second word is associated with a second discrete range of resistance values different from the first discrete range.

30. The method of claim 27, wherein said forming a first electrical trace and a second electrical trace includes controlling the width, thickness, and length of the first and second electrical traces to effectively match the first resistance ratio.

31. The method of claim 27, wherein said forming a first electrical trace and a second electrical trace includes controlling the material composition of the first and second electrical traces to effectively match the first resistance value.

32. The method of claim 27, wherein the first resistance ratio correlates to calibration information associated with the test strip.

33. The method of claim 27, wherein the first electrical trace is comprised of at least two different conductive materials.

34. The method of claim 27, wherein:

the first electrical trace includes a first gap and a first resistive element conductively bridging the first gap, and

the second electrical trace includes a second gap and a second resistive element conductively bridging the second gap.

35. A method, comprising:

forming a first test strip with a first mask configuration, the first mask configuration including

a first counter electrode,

a first working electrode,

a first reagent,

a first pair of electrical traces electrically disconnected from one another, and

a second pair of electrical traces electrically disconnected from one another,

wherein the first counter electrode, first working electrode, the first pair of electrical traces, and the second pair of electrical traces are connectable to a test meter for determining the concentration of an analyte of interest in a sample of bodily fluid;

conductively connecting the first pair of electrical traces with a first resistive element and forming a first electrical trace loop on the first test strip, the first electrical trace loop having a first associated resistance; and

conductively connecting the second pair of electrical traces with a second resistive element and forming a second electrical trace loop on the first test strip, the second electrical trace loop having a second associated resistance.

36. The method of claim 35, further comprising:

connecting the first test strip counter electrode, first test strip working electrode, first electrical trace loop and second electrical trace loop to a test meter; and

comparing the first and second associated resistances and obtaining a first resistance ratio with the test meter.

37. The method of claim 36, further comprising:

determining whether the first resistance ratio correlates to a predetermined value with the test meter;

applying a sample of bodily fluid to the first test strip; and

determining the concentration of an analyte of interest in the first sample of biological fluid with the test meter if the first resistance ratio correlates to the predetermined value.

38. The method of claim 35, wherein the first mask configuration further includes a third pair of electrical traces electrically disconnected from one another, and said forming a first test strip further includes conductively connecting the third pair of electrical traces with a third resistive element and forming a third electrical trace loop on the first test strip, the third electrical trace loop having a third associated resistance.

39. The method of claim 38, further comprising:

connecting the third electrical trace loop to the test meter; and

comparing the first and third associated resistances and obtaining a second resistance ratio with the test meter.

40. The method of claim 39, further comprising:

determining whether the third resistance ratio correlates to a predetermined value with the test meter.

41. The method of claim 35, further comprising:

forming a second test strip with a second mask configuration, the second mask configuration including

a second counter electrode,

a second working electrode,

a second reagent,

a third pair of electrical traces electrically disconnected from one another, and

a fourth pair of electrical traces electrically disconnected from one another,

wherein the second counter electrode, second working electrode, the third pair of electrical traces, and the fourth pair of electrical traces are connectable to a test meter for determining the concentration of an analyte of interest in a sample of bodily fluid;

conductively connecting the third pair of electrical traces with a third resistive element and forming a third electrical trace loop on the second test strip, the third resistive element having a third associated resistance, and

conductively connecting the fourth pair of electrical traces with a fourth resistive element and forming a fourth electrical trace loop on the second test strip, the fourth electrical trace loop having a fourth associated resistance.

42. The method of claim 41, further comprising:

connecting the first test strip counter electrode, first test strip working electrode, first electrical trace loop and second electrical trace loop to a test meter;

comparing the first and second associated resistances and obtaining a first resistance ratio with the test meter;

connecting the second test strip counter electrode, second test strip working electrode, third electrical trace loop and fourth electrical trace loop to a test meter;

comparing the third and fourth associated resistances and obtaining a second resistance ratio with the test meter.

43. The system of claim 42, wherein the first resistance ratio and said second resistance ratio are different.

44. The method of claim 42, further comprising:

determining whether the first resistance ratio correlates to a predetermined value with the test meter; and

determining whether the second resistance ratio correlates to a predetermined value with the test meter.

45. The method of claim 44, further comprising:

applying a first sample of biological fluid to the first test strip;

determining the concentration of an analyte of interest in the first sample of biological fluid if the first resistance ratio correlates to the predetermined value;

applying a second sample of biological fluid to the second test strip; and

determining the concentration of an analyte of interest in the second sample of biological fluid if the second resistance ratio correlates to the predetermined value.

46. The method of claim 44, further comprising:

inhibiting testing of the biological fluid for the analyte of interest by the test meter if the first resistance ratio correlates to the predetermined value; and

inhibiting testing of the biological fluid for the analyte of interest by the test meter if the second resistance ratio correlates to the predetermined value.

47. The method of claim 44, further comprising:

recording information relating to the first test strip with the test meter if the first resistance ratio correlates to the predetermined value; and

recording information relating to the second test strip with the test meter if the second resistance ratio correlates to the predetermined value.

48. The method of claim 42, further comprising:

comparing the first resistance ratio with at least two discrete, non-overlapping ranges using the test meter; and

comparing the second resistance ratio with the at least two discrete, non-overlapping ranges using the test meter.

49. The method of claim 42, further comprising:

correlating the first resistance ratio to calibration information associated with the first test strip; and

correlating the second resistance ratio to calibration information associated with the second test strip.

52. The method of claim 35, wherein

said forming a first test strip with a first mask configuration occurs at a first time;

and

said conductively connecting the first pair of electrical traces with a first resistive element occurs at a time different from the first time.

50. A method, comprising:

electrically connecting three electrical trace loops of a test strip to a test meter, the first electrical trace loop including

a counter electrode,

a working electrode, and

a reagent for determining the concentration of an analyte in a sample of bodily fluid,

the second electrical trace loop being different from the first electrical trace loop and including an associated resistance, and

the third electrical trace loop being different from the first and second electrical trace loops, the third electrical trace loop including an associated resistance; and

determining the ratio of the second electrical trace loop resistance and the third electrical trace loop resistance with the test meter.

51. The method of claim 50, further comprising:

determining the concentration of an analyte in a sample of bodily fluid applied to the test strip with the test meter if the ratio of the second and third trace loop resistances correlates to a predetermined value.