System and method for coding information on a biosensor test strip

• US 20050279647A1
• Filed: 04/01/2005
• Published: 12/22/2005
• 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
• Granted Patent: US 7,601,299 B2
• Time in Patent Office: Days
• US Class Current: 205/792
• 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 system for measuring a concentration of an analyte of interest in a biological fluid, comprising:

a test meter;

a first test strip with a first mask configuration, a first resistive element, and a second resistive element, said first mask configuration comprising;

a first measurement electrode connectable to said test meter,

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

a second trace loop with a second associated resistance and a second gap, said second trace loop connectable to said test meter;

wherein said first resistive element is conductively connected to said first trace loop and bridges said first gap; and

wherein said second resistive element is conductively connected to said second trace loop and bridges said second gap;

a second test strip with a second mask configuration, a third resistive element, and a fourth resistive element, said second mask configuration being substantially similar to said first mask configuration, said second mask configuration comprising;

a second measurement electrode connectable to said test meter,

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

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

wherein said third resistive element is conductively connected to said third trace loop and bridges said third gap; and

wherein said fourth resistive element is conductively connected to said fourth trace loop and bridges said fourth gap; and

wherein said test meter is adapted to;

receive said first and second test strips,

connect to said first and second measurement electrodes,

connect to said first and second trace loops,

obtain a first resistance ratio by comparing said first and second associated resistances,

connect to said third and fourth trace loops, and

obtain a second resistance ratio by comparing said third and fourth associated resistances.

2. The system of claim 1, wherein said first resistance ratio and said second resistance ratio are different.

3. The system of claim 1, wherein:

said test meter is adapted to determine whether said first resistance ratio correlates to a predetermined value when said test meter receives said first test strip, and

said test meter is adapted to determine whether said second resistance ratio correlates to a predetermined value when said test meter receives said second test strip.

4. The system of claim 3, wherein:

said test meter tests the biological fluid for the analyte of interest if said first resistance ratio correlates to said predetermined value, and

said test meter tests the biological fluid for the analyte of interest if said second resistance ratio correlates to said predetermined value.

5. The system of claim 3, wherein:

said test meter inhibits testing of the biological fluid for the analyte of interest if said first resistance ratio correlates to said predetermined value, and

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

6. The system of claim 3, wherein:

said test meter records information relating to said first test strip if said first resistance ratio correlates to said predetermined value, and

said test meter records information relating to said second test strip if said second resistance ratio correlates to said predetermined value.

7. The system of claim 1, wherein:

said test meter compares said first resistance ratio with at least two discrete, non-overlapping ranges, when said test meter receives said first test strip, and

said test meter compares said second resistance ratio with said at least two discrete, non-overlapping ranges, when said test meter receives said second test strip.

8. The system of claim 1, wherein:

said first resistance ratio correlates to calibration information associated with said first test strip, and

said second resistance ratio correlates to calibration information associated with said second test strip.

9. The system of claim 1, wherein

said first mask configuration further comprises a fifth trace loop with a fifth associated resistance and a fifth gap, said fifth trace loop connectable to said test meter, wherein said fifth resistive element is conductively connected to said fifth trace loop and bridges said fifth gap;

wherein said test meter is adapted to connect to said fifth trace loop and obtain a third resistance ratio by comparing said first and fifth associated resistances.

10. The system of claim 9, wherein said test meter is adapted to determine whether said third resistance ratio correlates to a predetermined value when said test meter receives said first test strip.

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

a test meter;

a first test strip, comprising;

a first measurement electrode connectable to said test meter,

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

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

wherein said test meter is adapted to;

receive said first test strip,

connect to said first measurement electrode, said first trace loop, and said second trace loop, and

obtain a first resistance ratio by comparing said first and second associated resistances.

12. The system of claim 11, wherein said test meter is adapted to measure said first and second associated resistances.

13. The system of claim 11, wherein said first resistance ratio is configured to correlate to a predetermined value.

14. The system of claim 11, wherein said test meter is adapted to determine whether said first resistance ratio correlates to a predetermined value.

15. The system of claim 14, wherein said test meter is adapted to test the biological fluid for the analyte of interest when said first resistance ratio correlates to said predetermined value.

16. The system of claim 14, wherein said test meter is adapted to inhibit testing of the biological fluid for the analyte of interest when said first resistance ratio correlates to said predetermined value.

17. The system of claim 14, wherein said test meter is adapted to record information relating to said first test strip when said first resistance ratio correlates to said predetermined value.

18. The system of claim 11, wherein said test meter is adapted to compare said first resistance ratio with at least two discrete, non-overlapping ranges, and wherein said first resistance ratio falls within a first one of said discrete ranges.

19. The system of claim 11, wherein said first trace loop comprises a first material and said second trace loop comprises a second material different from said first material.

20. The system of claim 11, wherein:

said first and second associated resistances are different;

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

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

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

21. The system of claim 11, wherein said first associated resistance and said second associated resistance correlate to calibration information associated with said first test strip.

22. The system of claim 11, further comprising a first measurement electrode trace conductively connected to said first measurement electrode, wherein said first trace loop comprises at least a portion of said first measurement electrode trace.

23. The system of claim 11, wherein

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

and

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

24. The system of claim 11, further comprising:

a second test strip, comprising;

a second measurement electrode connectable to said test meter,

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

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

wherein said test meter is adapted to;

receive said second test strip,

connect to said second measurement electrode, said third trace loop, and said fourth trace loop, and

obtain a second resistance ratio by comparing said third and fourth associated resistances.

25. The system of claim 24, wherein said first and second resistance ratios are different.

26. The system of claim 24, wherein:

said test meter is adapted to determine whether said first resistance ratio correlates to a predetermined value, and

said test meter is adapted to determine whether said second resistance ratio correlates to a predetermined value.

27. The system of claim 26, wherein:

said test meter is adapted to test the biological fluid for the analyte of interest when said first resistance ratio correlates to said predetermined value, and

said test meter is adapted to test the biological fluid for the analyte of interest when said second resistance ratio correlates to said predetermined value.

28. The system of claim 26, wherein:

said test meter is adapted to inhibit testing of the biological fluid for the analyte of interest when said first resistance ratio correlates to said predetermined value, and

said test meter is adapted to inhibit testing of the biological fluid for the analyte of interest when said second resistance ratio correlates to said predetermined value.

29. The system of claim 26, wherein:

said test meter is adapted to record information relating to said first test strip when said first resistance ratio correlates to said predetermined value, and

said test meter is adapted to record information relating to said first test strip when said second resistance ratio correlates to said predetermined value.

30. The system of claim 24, wherein:

said test meter is adapted to compare said first resistance ratio with at least two discrete, non-overlapping ranges, and wherein said first resistance ratio falls within a first one of said discrete ranges, and

said test meter is adapted to compare said second resistance ratio with said at least two discrete, non-overlapping ranges, and wherein said second resistance ratio falls within a second one of said discrete ranges.

31. The system of claim 24, wherein:

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

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

32. The system of claim 24, wherein:

said first and third associated resistances are different;

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

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

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

33. The system of claim 24, wherein:

said first test strip comprises;

a first mask configuration with a first gap in said first trace loop and a second gap in said second trace loop,

a first resistive element conductively connected to said first trace loop and bridging said first gap, and

a second resistive element conductively connected to said second trace loop and bridging said second gap;

said second test strip comprises;

a second mask configuration with a third gap in said third trace loop and a fourth gap in said fourth trace loop,

a third resistive element conductively connected to said third trace loop and bridging said third gap, and

a fourth resistive element conductively connected to said fourth trace loop and bridging said fourth gap; and

wherein said first mask configuration is substantially similar to said second mask configuration.

34. The system of claim 33, wherein said first resistive element has an associated resistance and said third resistive element has an associated resistance, and wherein said first resistive element associated resistance is different from said third resistive element associated resistance.

35. The system of claim 11,

wherein said first test strip comprises a third trace loop with a third associated resistance, said third trace loop connectable to said test meter, and

wherein said test meter is adapted to connect to said third trace loop and obtain a second resistance ratio by comparing said first and third associated resistances.

36. The system of claim 35, wherein said test meter is adapted to determine whether said second resistance ratio correlates to a predetermined value.

37. 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.

38. The method of claim 37, further comprising:

measuring the first and second associated resistances.

39. The method of claim 37, 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.

40. The method of claim 37, further comprising:

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

41. The method of claim 40, further comprising:

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

42. The method of claim 40, further comprising:

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

43. The method of claim 40, further comprising:

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

44. The method of claim 37, 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.

45. The method of claim 37, wherein the first trace loop comprises a first material and the second trace loop comprises a second material different from the first material.

46. The method of claim 37, 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.

47. The method of claim 37, wherein the first associated resistance and the second associated resistance correlate to calibration information associated with the first test strip.

48. The method of claim 37, 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.

49. The method of claim 37, 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.

50. The method of claim 37, 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.

51. The method of claim 50, wherein the first and second resistance ratios are different.

52. The method of claim 50, 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.

53. The method of claim 52, 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.

54. The method of claim 52, 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.

55. The method of claim 52, 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.

56. The method of claim 50, 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.

57. The method of claim 50, 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.

58. The method of claim 50, 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.

59. The method of claim 50, 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.

60. The method of claim 59, 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.

61. The method of claim 37,

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.

62. The method of claim 61, 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.

63. 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.

64. The method of claim 63, further comprising:

selecting a second resistance ratio associated with a second word desired to be encoded on the test strip, wherein said second resistance ratio is distinguishable from a substantially non-zero resistance value by a test meter; 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.

65. The method of claim 64, 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.

66. The method of claim 63, 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.

67. The method of claim 63, 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.

68. The method of claim 63, wherein the first resistance ratio correlates to calibration information associated with the test strip.

69. The method of claim 63, wherein the first electrical trace is comprised of at least two different conductive materials.

70. The method of claim 63, 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.