Assay Information Management Methods and Devices

• US 20110022331A1
• Filed: 07/27/2010
• Published: 01/27/2011
• Est. Priority Date: 07/27/2009
• Status: Abandoned Application

• Current Assignee: Meso Scale Technologies, LLC
• Original Assignee: Meso Scale Technologies, LLC
• Inventors: Glezer, Eli N., Cong, Xinri, Vock, Michael, Clinton, Charles M., Stevens, Carl, Willoughby, Jon S., Kumar, Sudeep
• Application Number:
  US12/844,345
• Publication Number:
  US 20110022331A1
• Time in Patent Office: Days
• US Class Current: 702/27
• CPC Class Codes: B01L 2300/02 Identification, exchange or storage of information
• CPC Class Codes: B01L 3/54 Labware with identification means identification of carriers, materials or components in automatic analysers G01N35/00732
• CPC Class Codes: G01N 2035/00633 logging process history of individual samples
• CPC Class Codes: G01N 2035/00851 process control parameters
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms
• CPC Class Codes: G01N 35/00663 of consumables
• CPC Class Codes: G16C 20/20 Identification of molecular entities, parts thereof or of chemical compositions
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis

Abstract

The present invention relates to methods, devices and systems for associating assay information with an assay consumable used in a biological assay. Provided are assay systems and associated consumables, wherein the assay system includes a reader adapted to read/erase/write information from/to an assay consumable identifier associated with the assay consumable. Various types of assay information are described, as well as methods of using such information in the conduct of an assay by an assay system.

Claims

1. An assay system configured to use an assay consumable in the conduct of an assay, said assay system comprising a reader adapted to perform an operation selected from the group consisting of (i) reading information from an assay consumable identifier associated with said assay consumable;

(ii) erasing information from said assay consumable identifier;

(iii) writing information to said assay consumable identifier; and

(vi) combinations thereof.

2. The assay system of claim 1, wherein said information is used by said system to adjust one or more operations performed by said system before, during and/or after the conduct of an assay by said system.

3. The assay system of claim 1 wherein said assay consumable comprises at least one assay test site for said assay.

4. The assay system of claim 3, wherein said test site comprises a plurality of distinct assay domains, at least two of said domains comprising reagents for measuring different analytes.

5. The assay system of claim 3 wherein said assay consumable comprises a plurality of test sites for a plurality of individual assays.

6. The assay system of claim 5 wherein said test sites are wells and/or chambers in said assay consumable.

7. The assay system of claim 6 wherein said assay consumable comprises a plurality of wells and said consumable further comprises an element selected from the group consisting of a plate top, plate bottom, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, dried and/or liquid assay reagents, and combinations thereof.

8. The assay system of claim 3 wherein said assay consumable comprises a flow cell.

9. The assay system of claim 8 wherein said assay consumable is a cartridge and said consumable further comprises an element selected from the group consisting of one or more fluidic components, one or more detection components, one or more assay cells, reagents for carrying out an assay, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, dried and/or liquid assay reagents, and combinations thereof.

10. The assay system of claim 9 wherein said cartridge comprises at least one assay cell that comprises a plurality of distinct assay domains, at least two of said domains comprising reagents for measuring different analytes.

11. The assay system of claim 1 wherein said assay consumable is a container holding one or more assay reagents.

12. The assay system of claim 1 wherein said assay consumable identifier is affixed to said assay consumable.

13. The assay system of claim 1 wherein said assay consumable identifier is affixed to a packaging for one or more assay consumables.

14. The assay system of claim 1 wherein assay consumable identifier comprises non-volatile memory.

15. The assay system of claim 14 wherein said non-volatile memory is selected from the group consisting of an RFID tag, a bar code, an EPROM, and EEPROM.

16. The assay system of claim 15 wherein said non-volatile memory is an EEPROM selected from the group consisting of flash memory and ICC.

17. The assay system of claim 3 wherein said information comprises information used to identify an element selected from the group consisting of (i) said assay consumable, (ii) one or more test sites within said consumable, (iii) a reagent and/or sample that has been or will be used in said consumable, and (iv) combinations thereof.

18. The assay system of claim 3 wherein said information is used to distinguish a first test site within said consumable from a different test site within said consumable.

19. The assay system of claim 3 wherein said information is consumable information selected from the group consisting of lot identification information;

lot specific analysis parameters, manufacturing process information, raw materials information, expiration date;

calibration data;

threshold information;

the location of individual assay reagents and/or samples within one or more test sites of the assay consumable;

Material Safety Data Sheet (MSDS) information, and combinations thereof.

20. The assay system of claim 3 wherein said information is sample information selected from the group consisting of the location of samples within said at least one test sites of the assay consumable;

assay results obtained on said assay consumable for said sample;

identity of samples that have been and/or will be assayed in said assay consumable; and

combinations thereof.

21. The assay system of claim 3, wherein said information is chain of custody information.

22. The assay system of claim 21, wherein said chain of custody information includes information regarding the control, transfer and/or analysis of said sample.

23. The assay system of claim 21 wherein said information is chain of custody information regarding the control, transfer and/or manufacture of said assay consumable.

24. The assay system of claim 21, wherein said chain of custody information is selected from the group consisting of user identification;

time and date stamp for said assay;

location of said assay system during said assay;

calibration and QC status of said assay system during said assay, custody and/or location information for said assay consumable before and after the conduct of said assay;

assay results for said sample; and

combinations thereof.

25. The assay system of claim 21, wherein said information is chain of custody information selected from the group consisting of time, date, manufacturing personnel or processing parameters for one or more steps during the manufacture of said assay consumable;

custody, location and or storage conditions for said assay consumable following manufacture and/or between steps during the manufacture of said assay consumable; and

combinations thereof.

26. The assay system of claim 3 wherein said information is consumable/test site information selected from the group consisting of consumable type and structure;

location and identity of assay reagents included with said assay consumable;

location and identity of assay reagents within an assay test site of said assay consumable; and

combinations thereof.

27. The assay system of claim 3 wherein said information is assay process information selected from the group consisting of assay parameters to be applied by said reader during the assay;

a sequence of steps to be applied by said reader during said assay;

the identity, concentration, and/or quantity of assay reagents to be used or added during said assay;

the type or wavelength of light to be applied and/or measured by the reader during said assay;

the temperature to be applied by the reader during said assay;

an incubation time for said assay;

statistical or analytical methods to be applied by the reader to raw data collected during said assay; and

combinations thereof.

28. The assay system of claim 27 wherein said assay is a multi-step assay and said assay process information relates to a step or step(s) of said multi-step assay.

29. The assay system of claim 26 wherein said consumable/test site information comprises information concerning assays previously performed by a reader on one or more test sites of said consumable;

information concerning assays to be performed by an assay reader or a component thereof on one or more test sites within said consumable; and

combinations thereof.

30. The assay system of claim 1 wherein said information is consumable security information selected from the group consisting of information concerning assay consumable authentication;

information concerning appropriate placement and/or orientation of said assay consumable in said system;

information concerning defects in said assay consumable and/or a test site thereof; and

combinations thereof.

31. The assay system of claim 1 wherein said information is used by said system to adjust the operation of a component of said assay system selected from the group consisting of one or more sensors;

mechanisms to transport the assay consumables into and out of the system;

mechanisms to align and orient the assay consumables with said one or more sensors and/or with electrical, mechanical or fluidic interfaces in said system;

mechanisms, electronics or software to track and/or identify assay consumables;

mechanisms to store, stack, move and/or distribute one or more consumables.

32. The assay system of claim 1 wherein said reader is mounted to a housing of said system.

33. The assay system of claim 1 wherein said reader is located within a housing of said system.

34. An assay system configured to use an assay consumable in the conduct of an assay comprising a reader adapted to perform an operation selected from the group consisting of (i) reading information from an assay consumable identifier associated with said assay consumable;

(ii) erasing information from said assay consumable identifier;

(iii) writing information to said assay consumable identifier; and

(iv) combinations thereof;

wherein said information comprises consumable/test site information selected from the group consisting of information concerning assays previously performed by a reader on one or more test sites of said consumable;

information concerning assays to be performed by an assay reader or a component thereof on one or more test sites within said consumable; and

combinations thereof.

35. The assay system of claim 34 wherein said consumable/test site information further comprises information selected from the group consisting of consumable type and structure;

location and identity of assay reagents included with said assay consumable;

location and identity of assay reagents within an assay test site of said assay consumable; and

combinations thereof.

36. An assay system configured to use an assay consumable in the conduct of an assay comprising a reader adapted to perform an operation selected from the group consisting of (i) reading information from an assay consumable identifier associated with said assay consumable;

(ii) erasing information from said assay consumable identifier;

(iii) writing information to said assay consumable identifier; and

(iv) combinations thereof;

wherein said information comprises consumable security information selected from the group consisting of information concerning assay consumable authentication;

information concerning appropriate placement and/or orientation of said assay consumable in said system;

information concerning defects in said assay consumable and/or a test site thereof; and

combinations thereof.

37. An assay system configured to use a multiplex enabled assay consumable in the conduct of a multiplexed assay, wherein said assay consumable comprises a plurality of test sites within which said multiplexed assay is performed and said assay system comprises a reader adapted to perform an operation selected from the group consisting of (i) reading information from an assay consumable identifier associated with said assay consumable;

(ii) erasing information from said assay consumable identifier;

(iii) writing information to said assay consumable identifier; and

(iv) combinations thereof.

38. The assay system of claim 37 wherein said information comprises information used to identify an element selected from the group consisting of (i) said assay consumable, (ii) one or more test sites within said consumable, (iii) a reagent and/or sample that has been or will be used in said consumable, and (iv) combinations thereof.

39. The assay system of claim 37 wherein said information is used to distinguish a first test site within said consumable from a different test site within said consumable.

40. The assay system of claim 37 wherein said information is consumable information selected from the group consisting of lot identification information;

lot specific analysis parameters, manufacturing process information, raw materials information, expiration date;

calibration data;

threshold information;

the location of individual assay reagents and/or samples within one or more test sites of the assay consumable;

Material Safety Data Sheet (MSDS) information, and combinations thereof.

41. The assay system of claim 37 wherein said information is sample information selected from the group consisting of the location of samples within said at least one test sites of the assay consumable;

assay results obtained on said assay consumable for said sample;

identity of samples that have been and/or will be assayed in said assay consumable; and

combinations thereof.

42. The assay system of claim 37, wherein said information is chain of custody information.

43. The assay system of claim 42, wherein said chain of custody information includes information regarding the control, transfer and/or analysis of said sample.

44. The assay system of claim 42 wherein said information is chain of custody information regarding the control, transfer and/or manufacture of said assay consumable.

45. The assay system of claim 42, wherein said chain of custody information is selected from the group consisting of user identification;

time and date stamp for said assay;

location of said assay system during said assay;

calibration and QC status of said assay system during said assay, custody and/or location information for said assay consumable before and after the conduct of said assay;

assay results for said sample; and

combinations thereof.

46. The assay system of claim 42, wherein said information is chain of custody information selected from the group consisting of time, date, manufacturing personnel or processing parameters for one or more steps during the manufacture of said assay consumable;

custody, location and or storage conditions for said assay consumable following manufacture and/or between steps during the manufacture of said assay consumable; and

combinations thereof.

47. The assay system of claim 37 wherein said information is consumable/test site information selected from the group consisting of consumable type and structure;

location and identity of assay reagents included with said assay consumable;

location and identity of assay reagents within an assay test site of said assay consumable; and

combinations thereof.

48. The assay system of claim 37 wherein said information is assay process information selected from the group consisting of assay parameters to be applied by said reader during the assay;

a sequence of steps to be applied by said reader during said assay;

the identity, concentration, and/or quantity of assay reagents to be used or added during said assay;

the type or wavelength of light to be applied and/or measured by the reader during said assay;

the temperature to be applied by the reader during said assay;

an incubation time for said assay;

statistical or analytical methods to be applied by the reader to raw data collected during said assay; and

combinations thereof.

49. The assay system of claim 37 wherein said assay is a multi-step assay and said assay process information relates to a step or step(s) of said multi-step assay.

50. The assay system of claim 47 wherein said consumable/test site information comprises information concerning assays previously performed by a reader on one or more test sites of said consumable;

information concerning assays to be performed by an assay reader or a component thereof on one or more test sites within said consumable; and

combinations thereof.

51. The assay system of claim 37 wherein said information is consumable security information selected from the group consisting of information concerning assay consumable authentication;

information concerning appropriate placement and/or orientation of said assay consumable in said system;

information concerning defects in said assay consumable and/or a test site thereof; and

combinations thereof.

52. An assay consumable comprising an assay consumable identifier comprising information, wherein said assay consumable is selected from the group consisting of (i) an assay consumable comprising at least one assay test site for said assay;

and (ii) a container adapted to hold one or more assay reagents.

53. The assay consumable of claim 52, wherein said assay consumable comprises at least one assay test site for said assay and said test site comprises a plurality of distinct assay domains, at least two of said domains comprising reagents for measuring different analytes.

54. The assay consumable of claim 52 wherein said assay consumable comprises a plurality of test sites for a plurality of individual assays.

55. The assay consumable of claim 54 wherein said test sites are wells and/or chambers in said assay consumable.

56. The assay consumable of claim 55 wherein said assay consumable comprises a plurality of wells and said further comprises a plurality of elements selected from the group consisting of a plate top, plate bottom, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, dried or liquid assay reagents, and combinations thereof.

57. The assay consumable of claim 54 wherein said assay consumable comprises a flow cell.

58. The assay consumable of claim 57 wherein said assay consumable is a cartridge and said consumable further comprises an element selected from the group consisting of one or more fluidic components, one or more detection components, one or more assay cells, reagents for carrying out an assay, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, dried or liquid assay reagents, and combinations thereof.

59. The assay consumable of claim 58 wherein said cartridge comprises at least one assay cell that comprises a plurality of distinct assay domains, each of said domains comprising reagents for measuring a different analyte.

60. The assay consumable of claim 52 wherein said assay consumable identifier is affixed to said assay consumable.

61. The assay consumable of claim 52 wherein said assay consumable identifier is affixed to a packaging for said assay consumable.

62. The assay consumable of claim 52 wherein assay consumable identifier comprises non-volatile memory.

63. The assay consumable of claim 62 wherein said non-volatile memory is selected from the group consisting of an RFID tag, a bar code, an EPROM, and EEPROM.

64. The assay consumable of claim 63 wherein said EEPROM is selected from the group consisting of flash memory and ICC.

65. A multiplex enabled assay consumable comprising (i) a plurality of test sites for an assay, wherein each of said test sites comprise a plurality of distinct assay domains, each of said domains comprising reagents for measuring a different analyte;

and (ii) an assay consumable identifier comprising information used to identify an element selected from the group consisting of (i) said assay consumable, (ii) one or more test sites within said consumable, (iii) a reagent and/or sample that has been or will be used in said consumable, and (iv) combinations thereof.

66. The assay consumable of claim 65 wherein said information is used to distinguish a first test site within said consumable from a different test site within said consumable.

67. The assay consumable of claim 65 wherein said information is consumable information selected from the group consisting of lot identification information;

lot specific analysis parameters, manufacturing process information, raw materials information, expiration date;

calibration data;

threshold information;

the location of individual assay reagents and/or samples within one or more test sites of the assay consumable;

Material Safety Data Sheet (MSDS) information, and combinations thereof.

68. The assay consumable of claim 65 wherein said information is sample information selected from the group consisting of the location of samples within said at least one test sites of the assay consumable;

assay results obtained on said assay consumable for said sample;

identity of samples that have been and/or will be assayed in said assay consumable; and

combinations thereof.

69. The assay consumable of claim 65, wherein said information is chain of custody information.

70. The assay consumable of claim 69, wherein said chain of custody information includes information regarding the control, transfer and/or analysis of said sample.

71. The assay consumable of claim 69 wherein said information is chain of custody information regarding the control, transfer and/or manufacture of said assay consumable.

72. The assay consumable of claim 69, wherein said chain of custody information is selected from the group consisting of user identification;

time and date stamp for said assay;

location of said assay system during said assay;

calibration and QC status of said assay system during said assay, custody and/or location information for said assay consumable before and after the conduct of said assay;

assay results for said sample; and

combinations thereof.

73. The assay consumable of claim 69, wherein said information is chain of custody information selected from the group consisting of time, date, manufacturing personnel or processing parameters for one or more steps during the manufacture of said assay consumable;

custody, location and or storage conditions for said assay consumable following manufacture and/or between steps during the manufacture of said assay consumable; and

combinations thereof.

74. The assay consumable of claim 65 wherein said information is consumable/test site information selected from the group consisting of consumable type and structure;

location and identity of assay reagents included with said assay consumable;

location and identity of assay reagents within an assay test site of said assay consumable; and

combinations thereof.

75. The assay consumable of claim 65 wherein said information is assay process information selected from the group consisting of assay parameters to be applied by said reader during the assay;

a sequence of steps to be applied by said reader during said assay;

the identity, concentration, and/or quantity of assay reagents to be used or added during said assay;

the type or wavelength of light to be applied and/or measured by the reader during said assay;

the temperature to be applied by the reader during said assay;

an incubation time for said assay;

statistical or analytical methods to be applied by the reader to raw data collected during said assay; and

combinations thereof.

76. The assay consumable of claim 75 wherein said assay is a multi-step assay and said assay process information relates to a step or step(s) of said multi-step assay.

77. The assay consumable of claim 74 wherein said consumable/test site information comprises information concerning assays previously performed by a reader on one or more test sites of said consumable;

information concerning assays to be performed by an assay reader or a component thereof on one or more test sites within said consumable; and

combinations thereof.

78. The assay consumable of claim 65 wherein said information is consumable security information selected from the group consisting of information concerning assay consumable authentication;

information concerning appropriate placement and/or orientation of said assay consumable in said system;

information concerning defects in said assay consumable and/or a test site thereof; and

combinations thereof.

79. A method of using an assay consumable in an assay system, wherein said assay consumable comprises a consumable identifier and said assay system comprises a reader adapted to perform an operation selected from the group consisting of (i) read information from said consumable identifier;

(ii) erase information from said consumable identifier;

(iii) write information to said consumable identifier; and

(iv) combinations thereof, said method comprising the steps of (a) reading information from said consumable identifier;

(b) conducting an assay in said assay system using said assay consumable; and

(c) writing information resulting from said assay conducted in step (b) to said consumable identifier.

80. A method of using an assay consumable in an assay system, wherein said assay consumable comprises a consumable identifier and said assay system comprises a reader adapted to perform an operation selected from the group consisting of (i) read information from said consumable identifier;

(ii) erase information from said consumable identifier;

(iii) write information to said consumable identifier; and

(iv) combinations thereof, said method comprising the steps of (a) reading information from said consumable identifier;

(b) conducting an assay in said assay system using said assay consumable;

(c) writing information resulting from said assay conducted in step (b) to said consumable identifier; and

(d) tracking use of said assay consumable.

81. A method of tracking use of an assay consumable comprising an assay consumable identifier and a plurality of test sites, said method comprising (a) reading test site usage information from said assay consumable identifier;

(b) identifying, based on said test site usage information, an available test site on said consumable;

(c) carrying out an assay using said available test site; and

(d) writing updated test site usage information to said assay identifier.

82. The method of claim 81 wherein said information is selected from the group consisting of chain of custody information;

assay results obtained on said assay consumable or one or more test site(s);

identity of samples that have been and/or will be assayed in said assay consumable or a portion thereof.

83. The method of claim 82 wherein said information is chain of custody information comprising information regarding the control, transfer and/or analysis of said sample.

84. The assay system of claim 82 wherein said information is chain of custody information comprising information regarding the control, transfer and/or manufacture of said assay consumable.

85. The assay system of claim 82, wherein said chain of custody information is selected from the group consisting of user identification;

time and date stamp for said assay;

location of said assay system during said assay;

calibration and QC status of said assay system during said assay, custody and/or location information for said assay consumable before and after the conduct of said assay;

assay results for said sample; and

combinations thereof.

86. The assay system of claim 82, wherein said information is chain of custody information selected from the group consisting of time, date, manufacturing personnel or processing parameters for one or more steps during the manufacture of said assay consumable;

custody, location and or storage conditions for said assay consumable following manufacture and/or between steps during the manufacture of said assay consumable; and

combinations thereof.

87. A method of tracking the manufacture of an assay consumable, wherein said assay consumable comprises an identifier and one or more component parts and said manufacturing process includes one or more operations conducted by one or more manufacturing consumables each comprising a reader adapted to perform an operation selected from the group consisting of (i) reading manufacturing information from said identifier;

(ii) erasing manufacturing information from said identifier;

(iii) writing manufacturing information to said identifier; and

(iv) combinations thereof;

said method comprising (a) affixing said identifier to a first component of said consumable;

(b) performing an operation of said manufacturing process;

(c) writing manufacturing information to said identifier, wherein said manufacturing information comprises information related to the operation performed in step (b);

(d) performing an additional step in said manufacturing process; and

(e) writing manufacturing information to said identifier, wherein said manufacturing information comprises information related to the operation performed in step (d).

88. The method of claim 87 wherein said manufacturing information is selected from the group consisting of lot-specific information;

reagent expiration date;

calibration data;

threshold information;

the location of individual reagents within a test site of the assay consumable;

chain of custody information; and

combinations thereof.

89. An assay system configured to use an assay cartridge in the conduct of an assay, said assay system comprising a reader adapted to perform the following operations (i) reading cartridge lot identification information from a first consumable identifier associated with said assay consumable;

(ii) reading lot specific parameters from an additional consumable identifier;

(iii) using said lot identification information and said lot specific parameters to adjust one or more operations performed by said assay system before, during and/or after the conduct of an assay by said system.

90. The assay system of claim 89 wherein said lot specific parameters are selected from the group consisting of (i) a revision level that determines schema used to interpret assay results and/or assay information;

(ii) cartridge type;

(iii) year of cartridge manufacture;

(iv) cartridge lot number;

(v) expiration date of cartridge and/or reagents used in said assay;

(vi) a cross-talk correction matrix to account for chemical cross-reactivity;

(vi) threshold values for assays to be conducted in said cartridge;

(vii) a range for internal positive control(s) used in said assay;

(viii) a ranges for each assay to be conducted in said cartridge for a positive control sample; and

(ix) a software checksum.

91. The assay system of claim 89 wherein said first consumable identifier comprises non-volatile memory.

92. The assay system of claim 91 wherein said non-volatile memory is selected from the group consisting of an RFID tag, a bar code, ICC, an EPROM, and EEPROM.

93. The assay system of claim 92 wherein said non-volatile memory is a bar code.

94. The assay system of claim 89 wherein said additional consumable identifier comprises non-volatile memory.

95. The assay system of claim 94 wherein said non-volatile memory is selected from the group consisting of an RFID tag, a bar code, ICC, an EPROM, and EEPROM.

96. The assay system of claim 95 wherein said non-volatile memory is an ICC.

97. The assay system of claim 96 wherein said ICC is a memory card.

99. The assay system of claim 89 wherein said assay information is selected from the group consisting of (i) a digital signature to verify manufacturer identify;

(ii) lot code of said multi-well assay plate;

(iii) expiration date of said multi-well assay plate;

(iv) type of multi-well assay plate;

(v) serialized identification for said additional multi-well assay plate; and

(vi) lot specific parameters for said multi-well assay plate.

100. The assay system of claim 99 wherein said lot specific parameters for said multi-well assay plate are selected from the group consisting of (i) in-well control acceptance ranges;

(ii) assay names;

(iii) assay identifiers;

(iv) assay thresholds;

(v) number and identity of assay quality controls;

(vi) assay quality control acceptance ranges;

(vii) calibration information;

(viii) number and identity of assay calibrators;

(ix) assay calibrator acceptance ranges;

(x) chemical cross-talk matrix for said multi-well assay plate; and

(xi) combinations thereof.

98. An assay system configured to use a multi-well assay plate, an additional multi-well assay plate, and one or more sample tube racks in the conduct of an assay, said assay system comprising a reader adapted to perform the following operations (i) reading tube position information from a first consumable identifier associated with said one or more sample tube racks;

(ii) reading assay information and lot specific parameters from an additional consumable identifier associated with said additional multi-well assay plate;

(iii) using position information and said lot specific parameters to adjust one or more operations performed by said assay system before, during and/or after the conduct of an assay on said multi-well assay plate by said system;

(iv) erasing information from said additional consumable identifier; and

(v) writing information to said additional consumable identifier.

101. The assay system of claim 98 wherein said first consumable identifier comprises non-volatile memory.

102. The assay system of claim 101 wherein said non-volatile memory is selected from the group consisting of an RFID tag, a bar code, ICC, an EPROM, and EEPROM.

103. The assay system of claim 102 wherein said non-volatile memory is a bar code.

104. The assay system of claim 98 wherein said additional consumable identifier comprises non-volatile memory.

105. The assay system of claim 104 wherein said non-volatile memory is selected from the group consisting of an RFID tag, a bar code, ICC, an EPROM, and EEPROM.

106. The assay system of claim 105 wherein said non-volatile memory is an EEPROM.