ERROR DETECTION AND REJECTION FOR A DIAGNOSTIC TESTING SYSTEM

• US 20080254544A1
• Filed: 04/12/2007
• Published: 10/16/2008
• Est. Priority Date: 04/12/2007
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Modzelewski, Brent E., Kayihan, Ferhan, Cardello, Edward
• Granted Patent: US 9,029,157 B2
• Time in Patent Office: Days
• US Class Current: 436/43
• CPC Class Codes: G01N 2035/00851 process control parameters
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G06F 11/0763 by bit configuration check, e.g. of formats or tags
• CPC Class Codes: Y10T 436/11 Automated chemical analysis

Abstract

A system for measuring a property of a sample is provided. The system comprises a diagnostic measuring device having a memory and a diagnostic test strip for collecting the sample. The strip has embedded thereon a pattern representative of at least first data and second data, the first data being data representing at least one of parameters related to measuring the property, codes usable for calibration of the diagnostic measuring device, or parameters indicating proper connection between the measuring device and the test strip and the second data usable for detecting and rejecting potential errors affecting the proper measurement of the property.

Claims

1. A system for measuring a property of a sample, comprising:

a diagnostic test strip for collecting the sample, the strip having information embedded thereon;

a diagnostic measuring device for receiving the test strip, reading the embedded information, and measuring the sample; and

the diagnostic device further comprising an error detection routine for detecting errors in the embedded information.

2. The system according to claim 1, further comprising

machine readable media wherein the error detection routine comprises an error detection algorithm located on said media, the error detection algorithm detecting errors in the information read by the diagnostic measuring device.

3. The system according to claim 2, wherein

the error detection algorithm comprises a trending algorithm.

4. The system according to claim 3, wherein

the trending algorithm compares a characteristic of the test strip to an expected value obtained by analyzing recorded characteristics of a plurality of previously used test strips.

5. The system according to claim 4, wherein

if the characteristic differs from the expected value, the error detection algorithm indicates that there is an error in the embedded information.

6. The system according to claim 4, wherein analyzing recorded characteristics comprises:

performing an auto-adaptive learning algorithm on the recorded characteristics to obtain the expected value.

7. The system according to claim 6, wherein

the auto-adaptive learning algorithm includes incorporating user feedback to obtain the expected value.

8. The system according to claim 2, wherein

the error detection algorithm comprises a checksum algorithm.

9. The system according to claim 8, wherein the checksum algorithm performed by the error detection routine comprises:

reading the information; and

determining the modulus of the bits contained in the information, wherein if the modulus is different than an expected value, the error detection algorithm indicates that there is an error in the embedded information.

10. The system according to claim 2, wherein:

the embedded information comprises a first code containing first information encoded in a first arrangement, and a second code containing the first information encoded in a second arrangement; and

the error detection algorithm comprises a redundant code algorithm.

11. The system according to claim 10, wherein the redundant code algorithm performed by the error detection routine comprises:

reading the first code; and

reading the second code, wherein it the first code and the second code do not match, the error detection algorithm indicates that there is an error in the first code.

12. The system according to claim 11, wherein

the first code is encoded using a first encoding method and the second code is encoded using a second encoding method.

13. The system according to claim 12, wherein

the first encoding method and the second encoding method each include one of encoding using printed insulating contact pads, encoding using contact pads having a variable resistance, encoding using optical markers, or magnetic encoding.

14. The system according to claim 2, wherein

the information comprises a code having a code value, the code having a plurality of units, each unit having a unit value, and

wherein the code value comprises a combination of the unit values.

15. The system according to claim 14, wherein

the unit values include digital bits, analog readings, symbols, or pictograms.

16. The system according to claim 14, wherein

the error detection algorithm comprises comparing the code value to a predetermined set of acceptable code values, wherein if the code value is not contained in the predetermined set of acceptable code values, the error detection algorithm indicates that there is an error in the code.

17. The system according to claim 14, wherein

the error detection algorithm comprises comparing the unit values to a predetermined set of acceptable unit values, wherein if a predetermined number of unit values are not contained in the predetermined set of acceptable unit values, the error detection algorithm indicates that there is an error in the code.

18. A system for measuring a property of a sample, comprising:

a diagnostic measuring device having a memory;

a diagnostic test strip for collecting the sample, the strip having a conductive pattern embedded thereon, the conductive pattern being representative of at least first data and second data, wherein;

the first data being data representing at least one of parameters related to measuring the property, codes usable for calibration of the diagnostic measuring device, or parameters indicating proper connection between the measuring device and the test strip; and

the second data usable for detecting and rejecting potential errors affecting the proper measurement of the property.

19. The system of claim 18, wherein the first data further comprises:

data representative of at least one of a particular test to be performed, parameters indicating connection to the strip, calibration coefficients, temperature correction coefficients, pH level correction coefficients, hematocrit data, and data for recognizing a particular type of diagnostic test strip.

20. The system of claim 18, wherein the property is the glucose level of the sample, the glucose level being indicative of a glucose level of a human subject.

21. The system of claim 18, wherein the first data is data for performing an automatic calibration of the measuring device.

22. The system of claim 18, wherein

a trending algorithm compares a characteristic of the test strip to an expected value obtained by analyzing recorded characteristics of previously used test strips.

23. The system of claim 22, wherein

if the characteristic differs from the second value, the measuring device indicates that there is an error.

24. The system of claim 22, wherein analyzing recorded characteristics comprises:

performing an auto-adaptive learning algorithm on the recorded characteristics to obtain the expected value.

25. The system of claim 24, wherein

the auto-adaptive learning algorithm includes incorporating user feedback to obtain the expected value.

26. The system of claim 18, wherein the second data comprises checksum data.

27. The system of claim 26, wherein the checksum data comprises a modulus of bits of the second data

28. The system of claim 27, wherein if the modulus is different from an expected value, the measuring device indicates that there is an error.

29. The system of claim 18, wherein the second data comprises third and fourth data arranged in a predetermined sequence.

30. The system of claim 29, wherein the third and fourth data are identical.

31. The system of claim 30, wherein the third and fourth data are arranged in different sequences.

32. The system of claim 30, wherein if the measuring device reads the third and fourth data and determines that the third and fourth data are not identical, the measuring device indicates an error.

33. The system of claim 30, wherein

the third data is encoded using a first encoding method and the fourth data is encoded using a second encoding method.

34. The system of claim 33, wherein

the first encoding method and the second encoding method each include one of encoding using printed insulating contact pads, encoding using contact pads having a variable resistance, encoding using optical markers, or magnetic encoding.

35. The system according to claim 18, wherein

the second data comprises a code having a code value, the code having a plurality of units, each unit having a unit value, and wherein the code value comprises a combination of the unit values.

36. The system according to claim 35, wherein

the unit values include digital bits, analog readings, symbols, or pictograms.

37. The system according to claim 35, wherein detecting and rejecting potential errors comprises:

comparing the code value to a predetermined set of acceptable code values, wherein if the code value is not contained in the predetermined set of acceptable code values, the measuring devices indicates an error.

38. The system according to claim 35, wherein detecting and rejecting potential errors comprises:

comparing the unit value to a predetermined set of acceptable unit values, wherein if the unit value is not contained in the predetermined set of acceptable unit values, the measuring devices indicates an error.

39. A method of determining a constituent level within a fluid comprising:

providing a diagnostic test meter, the test meter comprising a memory and a processor;

providing a diagnostic test strip, the test strip comprising at least one code embedded thereon;

inserting the test strip into the test meter, the test meter reading the at least one code;

performing an error detection and rejection algorithm on the at least one code; and

determining the constituent level of the fluid if the error detection and rejection algorithm does not detect an error.

40. The method of claim 39, wherein performing an error detection and rejection algorithm comprises:

performing a trending algorithm by comparing a characteristic of the test strip to an expected value obtained by analyzing recorded characteristics of a plurality of previously used test strips; and

determining an error on the test strip if the characteristic differs from the expected value.

41. The method of claim 40, further comprising:

performing an auto-adaptive learning algorithm on the recorded characteristics to obtain the expected value.

42. The method of claim 41, further comprising:

incorporating user feedback to obtain the expected value.

43. The method according to claim 39, wherein performing an error detection and rejection algorithm comprises:

computing the modulus of the at least one code;

comparing the modulus to an expected value; and

indicating that the test strip contains an error if the modulus is different than the expected value.

44. The method of claim 39, further comprising:

encoding the at least one code to have a first code containing first information, and a second code containing the first information.

45. The method of claim 44, wherein performing an error detection and rejection algorithm comprises:

reading the first code; and

reading the second code, wherein if the first code and the second code do not match, indicating that there is an error in the first code.

46. The method of claim 44, further comprising:

encoding the first code to have the first information in a first sequence; and

encoding the second code to have the first information in a second sequence.

47. The method of claim 44, further comprising:

encoding the first code using a first encoding method; and

encoding the second code using a second encoding method.

48. The method according to claim 47, wherein

the first encoding method and the second encoding method each include one of encoding using printed insulating contact pads, encoding using contact pads having a variable resistance, encoding using optical markers, or magnetic encoding.

49. The method according to claim 39, wherein

the at least one code has a code value, the code having a plurality of units, each unit having a unit value, and wherein the code value comprises a combination of the unit values.

50. The method according to claim 49, wherein

the unit values include digital bits, analog readings, symbols, or pictograms.

51. The method according to claim 49, wherein performing an error detection and rejection algorithm comprises:

comparing the code value to a predetermined set of acceptable code values, wherein if the code value is not contained in the predetermined set of acceptable code values, the error detection algorithm indicates that there is an error in the code.

52. The method according to claim 49, wherein performing an error detection and rejection algorithm comprises:

comparing the unit values to a predetermined set of acceptable unit values, wherein if a predetermined number of unit values are not contained in the predetermined set of acceptable unit values, the error detection algorithm indicates that there is an error in the code.

53. The method of claim 39, wherein performing an error detection and rejection algorithm comprises:

detecting an error in the at least one code; and

automatically correcting the error.

54. The method of claim 39, wherein the at least one code includes a Hamming code, and reading the code comprises statically reading the code.

55. A method for minimizing the impact of potential errors that may occur when a device reads a diagnostic test strip including a first code comprising a plurality of bits arranged in a physical arrangement, the method comprising:

determining a probability of each bit to cause a read error;

constructing a logical arrangement of the bits different than the physical arrangement based on the probability, wherein the logical arrangement corn rises the bits arranged such that the impact of potential read errors is minimized.

56. The method according to claim 55, wherein

the logical arrangement comprises the bits arranged such that the bit having the highest probability of causing a read error is logically replaced by the bit having the lowest probability of causing a read error, and the bit having the lowest probability of causing a read error is logically replaced by the bit having the highest probability of causing a read error.

57. The method according to claim 56, wherein

the logical arrangement results in a second code which is read in sequence.

58. The method according to claim 56, wherein

the logical arrangement results in a second code which is not read in sequence.