U.S. patent application number 12/844345 was filed with the patent office on 2011-01-27 for assay information management methods and devices.
This patent application is currently assigned to MESO SCALE TECHNOLOGIES, LLC. Invention is credited to Charles M. Clinton, Xinri Cong, Eli N. Glezer, Sudeep Kumar, Carl Stevens, Michael Vock, Jon S. Willoughby.
Application Number | 20110022331 12/844345 |
Document ID | / |
Family ID | 43498043 |
Filed Date | 2011-01-27 |
United States Patent
Application |
20110022331 |
Kind Code |
A1 |
Clinton; Charles M. ; et
al. |
January 27, 2011 |
Assay Information Management Methods and Devices
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.
Inventors: |
Clinton; Charles M.;
(Clarksburg, MD) ; Cong; Xinri; (Germantown,
MD) ; Glezer; Eli N.; (Chevy Chase, MD) ;
Kumar; Sudeep; (Gaithersburg, MD) ; Stevens;
Carl; (Silver Spring, MD) ; Vock; Michael;
(Loveland, OH) ; Willoughby; Jon S.; (Potomac,
MD) |
Correspondence
Address: |
SCULLY SCOTT MURPHY & PRESSER, PC
400 GARDEN CITY PLAZA, SUITE 300
GARDEN CITY
NY
11530
US
|
Assignee: |
MESO SCALE TECHNOLOGIES,
LLC
Gaithersburg
MD
|
Family ID: |
43498043 |
Appl. No.: |
12/844345 |
Filed: |
July 27, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61271873 |
Jul 27, 2009 |
|
|
|
Current U.S.
Class: |
702/27 |
Current CPC
Class: |
B01L 2300/02 20130101;
G16C 20/20 20190201; G01N 35/00663 20130101; G01N 2035/00633
20130101; B01L 3/54 20130101; G16H 10/40 20180101; G01N 33/54306
20130101; G01N 2035/00851 20130101 |
Class at
Publication: |
702/27 |
International
Class: |
G06F 19/00 20060101
G06F019/00 |
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.
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.
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.
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.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/271,873 filed on Jul. 27, 2009, the entire
contents of which are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present teaching relates to methods, devices and systems
for associating assay information with an assay consumable used in
a biological assay.
BACKGROUND OF THE INVENTION
[0003] Numerous methods and systems have been developed for
conducting assays. These methods and systems are essential in a
variety of applications including medical diagnostics, veterinary
testing, food and beverage testing, environmental monitoring,
manufacturing quality control, drug discovery, and basic scientific
research. During the manufacture and use of reagents and other
consumables used in biological assays, the reagents and consumables
are typically coded and labeled by the manufacturer in order to
track them. In addition, a myriad of analytical parameters must be
tracked in order to understand the analytical results of any given
assay, often requiring input from various parallel tracking systems
supplied by the manufacturer, user or both.
SUMMARY OF THE INVENTION
[0004] The present invention provides 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. In one embodiment, the 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.
[0005] In a specific embodiment, the 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. For example, the information is used to distinguish a
first test site within said consumable from a different test site
within said consumable. In one embodiment, the 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.
[0006] The information may also be 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. The information may include
chain of custody information, e.g., information regarding the
control, transfer and/or analysis of said sample. The chain of
custody information may include information concerning the control,
transfer and/or manufacture of said assay consumable, including but
not limited to 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. Still further, the 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.
[0007] In another embodiment, the 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.
[0008] Alternatively, the 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. In a further embodiment, the assay
is a multi-step assay and said assay process information relates to
a step or step(s) of said multi-step assay.
[0009] Still further, the 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.
[0010] The information may further include 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.
[0011] The information may be 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.
[0012] The invention further provides 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.
[0013] The invention also provides 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.
[0014] Still further, the invention contemplates 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.
[0015] The invention also provides 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.
[0016] In one embodiment, the invention provides 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.
[0017] The invention also contemplates 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.
[0018] Still further, the invention provides 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.
[0019] In one embodiment, the invention provides 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.
[0020] Moreover, the invention provides 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).
[0021] Also provided is 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. The lot specific parameters may be 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.
[0022] Still further, the invention provides 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.
DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS
[0023] Unless otherwise defined herein, scientific and technical
terms used in connection with the present invention shall have the
meanings that are commonly understood by those of ordinary skill in
the art. Further, unless otherwise required by context, singular
terms shall include pluralities and plural terms shall include the
singular. The articles "a" and "an" are used herein to refer to one
or to more than one (i.e., to at least one) of the grammatical
object of the article. By way of example, "an element" means one
element or more than one element.
[0024] The assay consumables and systems of the present invention
include a variety of devices and configurations. In one embodiment,
the assay system of the present invention includes an assay reader
capable of conducting a biological assay using an assay consumable.
The assay consumable comprises an identifier (referred to
alternatively throughout the specification as an identifier, a
consumable identifier, or an assay consumable identifier) and the
assay system, reader or a component thereof comprises an identifier
controller that interacts with the identifier. As described
hereinbelow, the identifier includes information concerning the
assay consumable, which may include but is not limited to, how the
consumable is manufactured and handled prior to use and how the
consumable is used in an assay system. Therefore, the assay system
is configured to use an assay consumable in the conduct of an
assay, and the assay system includes a reader adapted to perform an
operation selected from (i) reading information from an assay
consumable identifier associated with the assay consumable; (ii)
erasing information from the assay consumable identifier; and/or
(iii) writing information to the assay consumable identifier. The
information may be used by the system to perform a variety of
operations, e.g., to perform any aspect of a biological assay,
tracking the use and/or performance of the assay consumable and/or
the assay system, associating particular information unique to that
assay consumable with that consumable so that the information may
be accessed and used in subsequent applications in the same or a
different assay system, and/or to adjust one or more operations
performed by the system before, during and/or after the conduct of
an assay by the system.
[0025] The assay systems contemplated by the present invention are
used to conduct any type of diagnostic or analytical method known
in the art. Such analytical methods include but are not limited to
clinical chemistry assays (e.g., measurements of pH, ions, gases
and metabolites), hematological measurements, nucleic acid
amplification assays (e.g., polymerase chain reaction (PCR) and
ligase chain reaction assays), immunoassays (e.g., direct, sandwich
and/or competitive immunoassays and serological assays),
oligonucleotide ligation assays, and nucleic acid hybridization
assays. Any biological reagent that might be used in such
analytical methods may be used in such systems, including but not
limited to nucleic acids, nucleotides, oligonucleotides, DNA, RNA,
PNA, primers, probes, antibodies or fragments thereof, antigens,
small molecules, e.g., drugs or prodrugs, streptavidin, avidin, and
biotin.
[0026] These systems may be portable, e.g., hand-held, and/or
operated within a fixed laboratory or field setting, alone or in
combination with one or more additional components, assay devices
or systems. These systems may be used in a variety of applications,
from field operations to laboratory settings, in a wide variety of
industries, including but not limited to, medical, clinical,
forensic, pharmaceutical, environmental, veterinary, biological,
chemical, agricultural, waste management, hazardous chemical, drug
testing, and in defense applications, e.g., for the detection of
biological warfare agents. The assay systems and consumables used
in the present invention may detect an analyte of interest by any
suitable method, including but not limited to, optical,
electromechanical, radiowave, electromagnetic, colorimetric,
fluorimetric, chemiluminescent, electrochemiluminescent,
radiochemical, nuclear magnetic resonance, enzymatic, fluorescent,
particle-count, and cell-count based detection.
[0027] The assay consumable includes devices in which one or more
steps of an assay process are conducted and such devices may
include one or more test sites where an assay measurement is
conducted. In one embodiment, the assay consumable includes at
least one assay test site for an assay. A test site may include a
plurality of distinct assay domains, at least two of the domains
including reagents for measuring different analytes. Still further,
the consumable may include a plurality of test sites for a
plurality of individual assays. Alternatively, the assay consumable
may be a component that provides a reagent or other assay component
that is used by the system to conduct an assay. For example, the
assay consumable may be a container with one or more compartments
for holding assay reagents. The assay consumable (or test sites
therein) may be single use or it may be reusable. The assay
consumable may be configured to conduct one test or multiple tests
(sequentially or in parallel).
[0028] Test sites, as used herein, refer to regions of a consumable
that hold, contact and/or interrogate a sample. A test site may
include a plurality of distinct assay domains, at least two such
domains include reagents for measuring different analytes.
Consumables may comprise multiple test sites which may hold,
contact or otherwise interrogate distinct volumes (aliquots) of the
same sample and/or volumes of different samples. A sector of an
assay consumable refers to grouping of two or more test sites of
the consumable. Each test site may be used to conduct a single
measurement or multiple measurements on a volume of sample (for
example, the measurement of multiple different analytes in a
multiplexed assay format). Depending on the specific requirements
of an application, a consumable with multiple test sites may be
configured to use all of its test sites in parallel, to use its
test sites at different times (e.g., assigning unused test sites to
be used as new samples are delivered to the assay system), or a
combination of both modes of operation may be enabled.
[0029] The assay consumable may be any structure useful in
diagnostic applications and that structure may be dictated by the
particular assay format or detection method employed by the device.
Examples of assay consumables suitable for use with the invention
include, but are not limited to, test tubes, cuvettes, flow cells,
assay cartridges and cassettes (which may include integrated
fluidics for assay processing), multi-well plates, slides, assay
chips, lateral flow devices (e.g., strip tests), flow-through
devices (e.g., dot blots), pipette tips, solid phase supports for
biological reagents and the like. In certain embodiments, test
sites in the assay consumable are defined by compartments in the
assay consumable, e.g., wells, chambers, channels, flow cells and
the like. The assay consumable and/or test sites may include one or
more components used to carry out an assay measurement according to
one or more specific detection methodologies. Depending on the
function of the consumable and the detection modalities employed by
the assays system, examples of such components may include, but are
not limited to, lateral flow matrices, filtration matrices, optical
windows, sensors (e.g., electrochemical and optical sensors), solid
phase supports for binding reactions (e.g., coated slides, chips,
beads, pins, coated filtration or lateral flow matrices, tubes and
the like), reagents (dry or in liquid form), electrodes, analyte
selective membranes and the like.
[0030] In one embodiment, the assay consumable may be a device that
incorporates a conventional lateral flow test strip, e.g., an
immunoassay test strip, as an assay medium. In this example, the
device is molded to include an identifier or the identifier is
affixed to the device without any modification to the structure of
the device and/or the assay medium. In one embodiment, the device
is placed within the analytical system, i.e., the assay system, for
analysis and before, during or after the performance of the assay,
the identifier controller within, affixed to or associated with the
assay system reads the data contained on the identifier and uses
that data in the assay or after the assay is completed by the
system.
[0031] In another embodiment, the assay consumable and accompanying
assay system or reader is capable of performing a multiplex assay.
A multiplex assay is a type of assay in which multiple measurements
are performed on a single sample, e.g., by distributing samples
across multiple test sites and/or by carrying out multiple
measurements on volumes of samples in individual test sites. The
multiple measurements may include, but are not limited to, (i)
multiple replicates of a measurement for an analyte; (ii) multiple
measurements of a certain analyte (i.e., multiple non-identical
measurements for the same analyte, e.g., measurements that differ
in format or in the identity of the assay reagents that are
employed); and/or (iii) measurements of multiple different
analytes. In one specific embodiment, an assay consumable is
configured to carry out, in one or more test sites, multiplex
measurements that include at least two assays for two different
analytes.
[0032] The invention is not restricted to specific approaches for
conducting multiplex measurements in a test site and may employ any
of the numerous techniques that have been developed for carrying
out multiplex measurements. Multiplex measurements that can be used
with the invention include, but are not limited to, multiplex
measurements (i) that involve the use of multiple sensors; (ii)
that use discrete assay domains on a surface (e.g., an array) that
are distinguishable based on location on the surface; (iii) that
involve the use of reagents coated on particles that are
distinguishable based on a particle property, such as size, shape,
color, etc.; (iv) that produce assay signals that are
distinguishable based on optical properties (e.g., absorbance or
emission spectrum), (v) that are based on temporal properties of an
assay signal (e.g., time, frequency or phase of a signal), and/or
(vi) that are based on some other assay characteristic.
Accordingly, interpretation of multiplexed assay results may
involve the use of multiplexing information, such as the identity
of the assays carried out in each test site and, within a test
site, any assay characteristics (identity of specific sensors,
location and identity of assay domains, etc.) that are used to
distinguish assays carried out in a test site and/or that are used
to tie a specific assay identity to the corresponding assay
signal.
[0033] In one embodiment, an assay test site comprises a plurality
of distinct assay domains and each domain comprises one or more
reagents for measuring a different analyte. Multiplexing
information, including the location, identity, and composition of
each assay domain, is used to identify the assay signal generated
at each domain and connect it to a determination of the presence or
amount of the corresponding analyte (a process which may include
the application of additional assay information such as signal
thresholds and/or calibration parameters).
[0034] A test site may be configured to carry out a plurality of
multiplexed measurements (e.g., it may include a plurality of
distinct assay domains, wherein each domain comprises reagents for
measuring a different analyte). In one embodiment, the assay
consumable may include a plurality of test sites. Information
regarding the exact configuration of the one or more test sites,
assay domains, and/or one or more sectors in a consumable may be
included in the information saved to the assay consumable
identifier. This information may include the location and identity
of the test sites, assay domains, and/or one or more sectors as
well as multiplexing information (as described above) including the
number, identity and differentiating characteristics of the
individual measurements within a test site, assay domain, and/or
sector (e.g., the specific locations, identities and/or assay
reagents of assay domains within each test site). In addition, the
use of a test site, assay domain, and/or sector in an assay
consumable may also be recorded to the identifier to track the use
of the consumable in an assay system. The identifier may also
include information concerning the assay format and specific
processing steps to be used for an assay consumable or test site,
assay domain, and/or sector of an assay consumable. The identifier
may also include information concerning analytical methods that
should be applied by the system once an assay is conducted to
analyze the output of an assay in a given test site, assay domain,
and/or sector and, optionally, to provide results that combine the
output from multiple assays in a test site, assay domain, and/or
sectors.
[0035] The test sites may be configured in any suitable
configuration, depending on the geometry of the consumable and/or
the type of assay conducted with the consumable. In one embodiment,
the test sites are configured as wells and/or chambers in the assay
consumable. For example, the assay consumable of the present
invention may be a multi-well plate (e.g., a 24-, 96-, 384- or
1536-well plate), and the wells of the plate can further comprise a
plurality (e.g., 2 or more, 4 or more, 7 or more, 25 or more, 64 or
more, 100 or more, etc.) of distinct assay domains. Multi-domain
multi-well plates that are adapted to allow assay measurements to
be conducted using electrode induced luminescence measurements
(e.g., electrochemiluminescence measurements) are described in U.S.
application Ser. No. 10/238,391, entitled "Methods and Reader for
Conducting Multiple Measurements on a Sample", filed on Sep. 10,
2002, hereby incorporated by reference. The exact configuration of
the domains, test sites, and/or sectors in an assay consumable, as
well as the specific identity of each domain, test site, and/or
sector and the reagents bound to that domain/test site/sector may
be included in the information saved to the assay consumable
identifier. In addition, the use of a given domain, test site,
and/or sector in an assay consumable may also be recorded to the
identifier to track the use of the consumable in an assay
system.
[0036] Assay consumables can be used in a plurality of diverse
assays and this diversity leads to a variety of suitable
configurations of the associated consumable. In one assay format,
the same analyte is measured at different assay domains within a
test site, the different assay domains being designed to measure a
different property or activity of the analyte. Information
concerning the assay format that may be used in an assay
consumable, test site and/or assay domain may also be saved to the
assay consumable identifier. The identifier may also include
information concerning analytical methods that should be applied by
the system once an assay is conducted to analyze the output of an
assay in a given test site and/or domain and compare that output to
an assay in a separate test site and/or domain.
[0037] One example of a multiplex assay consumable and reader is
described in U.S. 2004/0022677, the disclosure of which is
incorporated herein by reference in its entirety. Such assay
consumables include one or more, and in one embodiment, a plurality
of test sites and/or assay domains for conducting one or more assay
measurements simultaneously or sequentially. For example, the test
sites may be configured as wells and/or chambers. These test sites
and/or assay domains comprise one or more electrodes for inducing
luminescence from materials in the test sites and/or assay domains.
The assay consumables may further comprise assay reagents in liquid
or dry form, e.g., in the test sites, e.g., wells or chambers, of
the consumable.
[0038] In addition to the test sites and assay domains, an assay
consumable or multi-well assay plate may include several additional
elements, e.g., a plate top, plate bottom, wells, working
electrodes, counter electrodes, reference electrodes, dielectric
materials, electrical connections, and assay reagents. The wells of
the plate may be defined by holes or openings in the plate top, or
as indentations or dimples on a surface of a plate. The plates may
have any number of wells of any size or shape, arranged in any
pattern or configuration and can be composed of a variety of
different materials. Exemplary embodiments of consumables that may
be used in the present invention include industry standard formats
for the number, size, shape and configuration of the plate and
wells, e.g., 96-, 384-, and 1536-well plates, with the wells
configured in two-dimensional arrays. Other formats may include
single well plates, 2-well plates, 6-well plates, 24-well plates,
and 6144-well plates. Multi-well assay plates may be used once or
may be used multiple times and are well suited to applications
where the plates are disposable. Various configurations for
suitable assay plates may be used in the present invention,
including but not limited to those depicted in FIGS. 11A, 12A, 13A,
13B, 14A, 15, and 16A of U.S. Application Ser. No. 2004/0022677,
each of which are incorporated herein by reference. As stated
above, the specific configuration and identity of assay test sites,
domains, and/or sectors of an assay consumable may be included in
the information saved to the assay consumable identifier.
[0039] In this embodiment, the assay consumables may be used in a
reader that can be used to induce and measure luminescence, e.g.,
electrode induced luminescence or electrochemiluminescence, in
assays conducted in or on assay consumables, e.g., multi-well assay
plates. The accompanying assay system can also induce and/or
measure current and/or voltage, for example, at an electrode. The
assay system may incorporate, for example, one or more
photodetectors; a light tight enclosure; mechanisms to transport
the assay plates into and out of the reader (and in particular,
into and out of a light tight enclosure); mechanisms to align and
orient the assay plates with the photodetector(s) and/or with
electrical contacts; additional mechanisms to track and identify
plates (e.g. bar code readers); mechanisms to make electrical
connections to plates, one or more sources of electrical energy for
inducing luminescence, and appropriate devices, electronics and/or
software. The assay reader may also include mechanisms to store,
stack, move and/or distribute one or more multi-well assay plates
(e.g. plate stackers and/or plate conveyors). The assay system may
be configured to measure light from multi-well assay plates by
measuring light sequentially from a plurality of sectors or regions
of the plate (i.e., a grouping of a plurality of adjacent assay
domains within a plate) and/or from the entire plate substantially
simultaneously or simultaneously. The assay system may also
incorporate additional microprocessors and computers to control
certain functions within the system and to aid in the storage,
analysis and presentation of data. Various configurations for
suitable assay systems may be used in the present invention,
including but not limited to those depicted in FIGS. 17 to 23 of
U.S. Application Ser. No. 2004/0022677, each of which are
incorporated herein by reference.
[0040] The additional microprocessors and computers in the assay
system may also interact with the assay consumable identifier
microprocessor or controllers by transferring data and commands
to/from the identifier to the various microprocessors/controllers
throughout the system to perform various operations of the
components listed above within the assay system.
[0041] One assay procedure using an assay consumable, e.g., a
multi-domain multi-well plate, and an assay system would comprise
inserting the consumable in the system to allow the identifier
controller to interact with the identifier affixed to or associated
with the consumable. Alternatively, the consumable packaging
includes the identifier affixed thereto or associated therewith and
before the consumable is inserted into the system, the identifier
associated with the consumable packaging is contacted with the
identifier controller. The system may adjust the assay parameters
prior to initiating an assay based on the assay information saved
to the identifier. Thereafter, the system makes the appropriate
electrical, fluidic and/or optical connections to the consumable
(making use of electrical, fluidic and/or optical connectors on the
consumable and system) and conducts an assay using the consumable.
The sample may be introduced into the consumable prior to inserting
the consumable in the system. Alternatively, the sample is
introduced by a component of the system after the consumable is
inserted in the system. The assay may also involve adding one or
more assay reagents to the consumable and instructions for adding
those various assay reagents may be saved to the identifier and the
system adds those reagents to the consumable before or during the
assay according to the instructions saved to the assay consumable
identifier.
[0042] Alternatively, the assay consumable is a cartridge and the
consumable further comprises an element selected from 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. The cartridge may further
comprise at least one assay cell that comprises a plurality of
distinct assay test sites and/or domains, each of these test sites
and/or domains comprising reagents for measuring a different
analyte.
[0043] An example of an assay consumable cartridge that may be used
in the present invention is described in US Application Ser. No.
2004/0189311, the disclosure of which is incorporated herein by
reference in its entirety. The assay consumable described therein
is an assay cartridge that incorporates one or more fluidic
components such as compartments, wells, chambers, fluidic conduits,
fluid ports/vents, valves, and the like and/or one or more
detection components such as electrodes, electrode contacts,
sensors (e.g. electrochemical sensors, fluid sensors, mass sensors,
optical sensors, capacitive sensors, impedance sensors, optical
waveguides, etc.), detection windows (e.g. windows configured to
allow optical measurements on samples in the cartridge such as
measurements of absorbance, light scattering, light refraction,
light reflection, fluorescence, phosphorescence, chemiluminescence,
electrochemiluminescence, etc.), and the like. Such consumables may
also comprise reagents for carrying out an assay such as binding
reagents, detectable labels, sample processing reagents, wash
solutions, buffers, etc. The reagents may be present in liquid
form, solid form and/or immobilized on the surface of solid phase
supports present in the cartridge. In this embodiment, the
consumables include all the components necessary for carrying out
an assay. In addition, the assay consumable is used in connection
with a consumable reader adapted to receive the consumable and
carry out certain operations on the consumable such as controlling
fluid movement, supplying power, conducting physical measurements
on the cartridge, and the like.
[0044] More specifically, such assay consumable cartridges have one
or more assay test sites (e.g., wells, compartments, chambers,
conduits, flow cells, etc.) that may include one or more assay
domains (e.g., discrete locations on a assay test site surface
where an assay reaction occurs and/or where an assay dependent
signal, such as an electrochemical or an electrode induced
luminescence signal is induced) for carrying out a plurality of
assay measurements. In this embodiment, assay domains are supported
on assay electrodes (in one embodiment, an array of assay
electrodes, e.g., a one dimensional array of assay electrodes) so
as to permit the conduct of assays based on electrochemical or
electrode induced luminescence measurements. The assay domains are,
optionally, defined by a dielectric layer deposited on the
electrodes. In addition, the assay consumables may have one or more
attributes that make them suitable for use in "point of care"
clinical measurements, e.g., small size, low cost, disposability,
multiplexed detection, ease of use, etc.
[0045] The assay consumable cartridge may comprise the necessary
electronic components and/or active mechanical components for
carrying out an assay measurement, e.g., one or more sources of
electrical energy, ammeters, potentiometers, light detectors,
temperature monitors or controllers, pumps, valves, etc.
Alternatively, some or all of the electronic and/or active
mechanical components are arranged within a separate assay reader.
The reader would also have the appropriate electrical, fluidic
and/or optical connections to the assay consumable for carrying out
an assay using the consumable. Using such an arrangement, the assay
consumable can be designed to be low cost and disposable while the
reader (which holds the more expensive and complex components) is
reusable.
[0046] An assay procedure using an assay consumable cartridge and
an assay system, e.g., an assay reader, may include inserting the
cartridge in the reader to allow the identifier controller to
interact with the identifier affixed to or associated with the
cartridge. Alternatively, the cartridge packaging includes the
identifier affixed thereto or associated therewith and before the
cartridge is inserted into the reader, the identifier of the
cartridge packaging is contacted with the identifier controller.
The reader may adjust the assay parameters prior to initiating an
assay based on the assay information saved to the identifier.
Thereafter, the reader makes the appropriate electrical, fluidic
and/or optical connections to the cartridge (making use of
electrical, fluidic and/or optical connectors on the cartridge and
reader) and conducts an assay in the cartridge. The sample is may
be introduced into the cartridge prior to inserting the cartridge
in the reader. The assay may also involve adding one or more assay
reagents to the cartridge and instructions for adding those various
assay reagents may be saved to the identifier and the reader adds
those reagents to the cartridge before or during the assay
according to the instructions saved to the assay consumable
identifier.
[0047] In one embodiment, a cartridge-based biochemical detection
system may include a system housing comprising an optical detector
wherein the system housing is adapted and configured to receive and
position the assay consumable and/or the optical detector for
processing. The system may further comprise support subsystems that
may include one or more of the following: storage subsystem for
storing assay reagents/consumables and/or waste; sample
acquisition/preprocessing/storage subsystem for sample handling;
fluidic handling subsystem for handling the reagents, sample,
waste, etc. and for providing fluids to the detection chamber via a
fluid inlet line; electrical subsystem for electrically contacting
the cartridge's electrical contacts and supplying electrical energy
to the electrodes; and a control subsystem for controlling and
coordinating operation of the system and subsystems and for
acquiring, processing and storing the optical detection signal. The
information stored to the assay consumable identifier may include
information that is used to control or adjust one or more of the
assay system components prior to and/or during the conduct of an
assay using the assay consumable.
[0048] Still further, the assay consumable may be a container
holding one or more assay reagents, including but not limited to
one or more buffers, diluents, and/or reagents used by the assay
system in the conduct of an assay. The assay consumable identifier
may be affixed to the container and/or affixed to a packaging for
the container.
[0049] In one embodiment, the assay consumable identifier comprises
memory for storing information related to the consumable, its
history and/or its use. In one embodiment, the memory is
non-volatile memory. Non-volatile memory is computer memory that
can retain the stored information without power. Examples of
non-volatile memory which may be used in the consumable identifier
include, but are not limited to, electronic non-volatile memory
(e.g., read-only memory and flash memory), magnetic memory (e.g.,
hard disks, floppy disk drives, and magnetic tape), optical memory
(optical disc drives) and hybrids of these approaches (e.g.,
magneto-optical memory).
[0050] In one embodiment, the assay consumable identifier comprises
EPROM (erasable programmable read-only memory), a type of
programmable read-only memory that can be erased by exposing it to
ultraviolet light. Once erased, it can be reprogrammed with new or
modified data. In another embodiment, the assay consumable
identifier comprises EEPROM (electronically erasable programmable
read-only memory) a class of non-volatile electronic memory that
can be electrically erased and reprogrammed without exposure to UV
light. An EEPROM can be written to or programmed more than once and
can be selectively programmed (the user can alter the value of
certain cells without erasing the programming of the other cells).
Therefore, sections of data can be erased and replaced without
needing to alter or reinstall the rest of the chip's
programming.
[0051] In another embodiment, the assay consumable identifier
comprises flash memory, a specific type of EEPROM that is erased
and programmed in large blocks. Although flash memory is
technically a type of EEPROM, the term "EEPROM" is generally used
to refer specifically to non-flash EEPROM which is erasable in
small blocks, typically bytes. Because erase cycles are slow, the
large block sizes used in flash memory erasing give it a
significant speed advantage over conventional EEPROM when writing
large amounts of data.
[0052] In another embodiment, the assay consumable identifier
comprises a smart card, chip card, or integrated circuit card (ICC)
(referred to collectively as "ICCs"). These are small cards with
embedded integrated circuits which can process and store data.
There are two broad categories of ICCs; i) "memory cards" that
contain non-volatile memory storage components and, optionally,
some specific security logic but do not contain microprocessors and
Ii) "microprocessor cards" that combine non-volatile memory
components with microprocessor components and enable the processing
of information being read into or out of the ICC. The ICC
electronic components are supported on a card that is, typically,
made of plastic such as PVC or ABS. The card may include an
embedded hologram to avoid counterfeiting. Contact ICCs have
conductive contact pads. When inserted into a reader, the contact
pads on the ICC make contact with electrical connectors in the
reader to allow for transfer of information between the reader and
the ICC, for example, allowing the reader to read, erase or write
information on the ICC.
[0053] Another method of transferring information is via an RFID,
i.e., radio frequency identification, which is similar in theory to
bar code identification. With RFID, the electromagnetic or
electrostatic coupling in the RF portion of the electromagnetic
spectrum is used to transmit signals. An RFID system consists of an
antenna and a transceiver, which read the radio frequency and
transfers the information to a processing device, and a
transponder, or tag, which is an integrated circuit containing the
RF circuitry and information to be transmitted.
[0054] Identification can also be accomplished by reading a bar
code. One of the key differences between RFID and bar code
technology is that RFID eliminates the need for line-of-sight
reading that bar coding depends on. Also, RFID scanning can be done
at greater distances than bar code scanning. High frequency RFID
systems (850 MHz to 950 MHz and 2.4 GHz to 2.5 GHz) offer
transmission ranges of more than 90 feet, although wavelengths in
the 2.4 GHz range are absorbed by water (the human body) and
therefore has limitations.
[0055] In one embodiment, the non-volatile memory used in the
present invention is selected from the group consisting of an
EEPROM, flash memory, ICC and combinations thereof. In one
embodiment, the non-volatile memory is an EEPROM. In an alternate
embodiment, the non-volatile memory is an RFID.
[0056] In an additional alternative embodiment, two or more
non-volatile memory components may be used in the present
invention. For example, a first assay consumable comprising a first
identifier may be used in the assay system, and an additional assay
consumable comprising an additional identifier may also be used in
the assay system. Each identifier may include the same or different
type of memory. However, for each different form of memory, there
will be a separate identifier controller. And certain assay
information may be stored on one identifier and other assay
information on an additional identifier of the same or different
type. For example, one assay consumable used in the system may
comprise an EEPROM or RFID as an identifier, whereas the system may
also use an additional assay consumable comprising, e.g., a bar
code as a identifier. The assay system would comprise an identifier
controller capable of interfacing with the first identifier, i.e.,
the EEPROM or RFID, and the system will further comprise an
additional controller that will interface with the bar code.
[0057] The assay system of the present invention includes an
identifier controller that controls the operation of the
non-volatile memory and other components of the assay system. The
identifier controller optionally includes a micro-controller to
interface with the non-volatile memory over a communication
interface, which may incorporate conventional interface
architectures and protocols such as I.sup.2C, a two line serial bus
protocol. The microcontroller addresses the non-volatile memory and
performs write, read and erase operations on the memory.
[0058] The consumable identifier may be located on the consumable
or it may be a separate component. In either case, the system may
be designed to have a unique identifier for each consumable.
Alternatively, the system may be configured so that one separate
consumable identifier is used to hold information relating to a
plurality of consumables. In one example, each package of
consumables has a package-specific identifier mounted on the
package (or, alternatively, supplied in the package) that holds
information relating to the plurality of consumables in the
package. Optionally, each consumable also carries an additional
unique consumable-specific identifier attached to the consumable.
This consumable-specific identifier is used primarily to uniquely
identify the consumable and link it to information on the
package-specific identifier. In this embodiment, lot information
content and/or non-editable identifiers such as bar codes may be
used.
[0059] The various components of the assay system may be housed
together in a single unit or may be housed separately. For example,
the assay system may include an assay reader and an identifier
controller as separate units. The assay system provides for
communication (which may be wired or wireless communication)
directly between the assay reader and identifier controller or,
alternately, indirectly through additional components of the assay
system. In an alternative embodiment, the identifier controller is
housed within the assay reader. In such an embodiment, the assay
reader may be configured such that insertion of the consumable into
the reader during the conduct of an assay also enables
communication between the consumable identifier and the identifier
controller (e.g., a port into which the consumable is inserted
includes components for processing and/or reading the consumable
and also includes components, such as electrical contacts or a
radio transmitter, for communicating with the consumable
identifier). In one example, when the consumable is loaded into the
assay system, electrical contacts are made between the controller
and the identifier, e.g., non-volatile memory. The controller is
then able to read, erase and/or write assay information to the
identifier. Alternatively, the assay reader may have separate ports
for processing/reading a cartridge and for communicating with the
consumable identifier. The user places the assay consumable or
packaging in or in proximity to the controller port such that the
controller makes electrical contact with the identifier to enable
the controller to read, erase and/or write assay information to the
non-volatile memory
[0060] In one embodiment, the identifier comprises non-volatile
memory selected from the group consisting of an RFID tag, a bar
code, an EPROM, and EEPROM. Still further, the identifier may
comprise an EEPROM selected from the group consisting of flash
memory and ICC.
[0061] The identifier is programmed, e.g., during the manufacturing
process or at another time prior to use in the assay system. The
identifier may be programmed with information (referred to herein
as "assay information") which is used before, during or after an
assay or a step of a multi-step assay to control the operation of
the assay system, reader or a component of the assay system. The
term "assay information" may include any information used to
uniquely identify a particular assay or assay step, assay
consumable, consumable domain(s), biological reagent or sample or
to distinguish a particular assay, assay step, assay consumable,
consumable domain(s), biological reagent or sample from other assay
consumables, consumable domains, biological reagents or samples.
Assay information may include consumable information, sample
information, chain of custody information, consumable/test site
information, assay process information, consumable security
information, and combinations thereof. Each type of assay
information is described in more detail below.
[0062] For example, the assay information may include consumable
information that includes but is not limited to lot identification
information, lot specific analysis parameters, manufacturing
process information, raw materials information, expiration date,
Material Safety Data Sheet (MSDS) information, product insert
information (i.e., any information that might be included or
described in a product insert that would accompany the assay
consumable, e.g., the assay type, how the assay is performed,
directions for use of the assay consumable, assay reagents, or
both, etc.), threshold and/or calibration data for one or more
reagents used in the assay consumable or in an assay or a step of a
multi-step assay, and the location of individual assay reagents
and/or samples within one or more test sites of the assay
consumable.
[0063] The consumable identifier may also include lot
identification information, i.e., information that is used to
identify a particular lot of assay consumables, which is distinct
from lot-specific analysis parameters, which includes that
information that is unique to a given lot that may be used by the
system, e.g., to conduct an assay with a consumable from that lot
or to analyze assay results derived from a consumable from that
lot. In one embodiment, if the assay consumable is a multi-well
assay plate or a cartridge, the lot-specific analysis parameters
may include, but are not limited to, the following: (i) the
revision level that determines the schema used to interpret the
information; (ii) the consumable type; (iii) the date of
manufacture; (iv) the lot number; (v) the date of expiration; (vi)
a cross-talk correction matrix, to account for chemical
cross-reactivity; (vii) a threshold for assays to be conducted in
the consumable and each internal negative control; (viii) a range
for each internal positive control; (ix) ranges for each assay to
be conducted in the cartridge for the positive control sample; (x)
a software checksum to ensure integrity of the data; (xi) in-well
(or in-test site) control acceptance ranges; (xii) assay names
and/or identifiers; (xiii) information concerning assay quality
control, including negative and positive quality control materials
that are used to verify the operation of the reader and the
consumable; (xiv) calibration information such as a master
calibration curve; and (xv) number and names of assay calibrators
and/or assay calibrator acceptance ranges.
[0064] The assay information may include sample information, such
as the location of samples within at least one test site of the
assay consumable, assay results obtained on said assay consumable
for the sample, and the identify of samples that have been and/or
will be assay in the assay consumable.
[0065] The assay information may also relate to chain of custody,
e.g., information regarding the control, transfer and/or analysis
of the sample and/or an assay consumable. Chain of custody
information may be selected from user identification, sample
identification, time and date stamp for an assay, the location of
the assay system in a laboratory during the assay, calibration and
QC (quality control) status of the assay system during the assay,
custody and/or location information for the assay consumable before
and after the conduct of the assay, assay results for a given
sample, as well as user created free text comments input before,
during or after an assay is processed by the system. Still further,
chain of custody information may include time, date, manufacturing
personnel or processing parameters for one or more steps during the
manufacture of the assay consumable, custody, location and/or
storage conditions for the assay consumable following manufacture
and/or between steps during the manufacture of the assay
consumable.
[0066] Assay information may also include consumable/test site
information, such as consumable type and structure, the location
and identity (e.g., the structure, composition, sequence,
concentration and/or origin) of assay reagents included within an
assay consumable, and the location and identity of assay reagents
within an assay test site of the assay consumable.
[0067] In addition, the assay information may include assay process
information concerning the individual assay parameters that should
be applied by the system or reader during the assay. For example,
such assay information may include a sequence of steps for a given
assay, the identity, concentration and/or quantity of assay
reagents that should be used or added during the assay or during a
particular step of an assay, e.g., buffers, diluents, and/or
calibrators that should be used in that assay. In addition, the
assay information may include data regarding how one or more steps
in an assay protocol (e.g., dilution or reagent addition steps) may
be adjusted to account for lot to lot or consumable to consumable
differences. The amount of diluent added and/or the nature of the
diluent may be altered based on such differences. Similarly, the
amount of a given reagent that may be added during the conduct of
an assay, an incubation period and/or temperature for one or more
steps of an assay may also be dependent on lot to lot or consumable
to consumable differences.
[0068] The assay information may also include the type or
wavelength of light that should be applied and/or measured by the
system or reader during the assay or a particular step of a
multi-step assay; the temperature that should be applied by the
system or reader during the assay; the incubation time for an
assay; and statistical or other analytical methods that should be
applied by the system or reader to the raw data collected during
the assay.
[0069] In an additional embodiment, the information includes
consumable/test site information i.e., information concerning
assays previously performed by a reader on one or more test sites
of the consumable, and information concerning assays to be
performed by a reader on one or more test sites within the
consumable. Therefore, once the assay is conducted by the system,
the controller may be used to write the results of the assay to the
identifier. Such information includes, but is not limited to raw or
analyzed data collected by the system during the assay (wherein
analyzed data is data that has been subjected to statistical
analysis after collection and raw data is data that has not been
subjected to such statistical analysis), a list of test sites
and/or domains within the assay consumable used during a given
assay, a schedule of events to be conducted on an assay consumable
or a test site and/or domain within an assay consumable, a list of
those test sites and/or domains of the assay device that have not
be subjected to an assay, assay or system errors that resulted
during a given assay or assay step, and combinations thereof.
[0070] Moreover, the information comprises data that directly or
indirectly controls a component of the assay system, e.g., one or
more photodetectors, a light tight enclosure; mechanisms to
transport the assay consumables into and out of the reader;
mechanisms to align and orient the assay consumables with the one
or more photodetector(s) and/or with electrical contacts in the
reader; additional mechanisms and/or data storage media to track
and/or identify assay consumables; one or more sources of
electrical energy to induce luminescence; mechanisms to store,
stack, move and/or distribute one or more consumables; mechanisms
to measure light from a consumable during the assay sequentially,
substantially simultaneously or simultaneously from a plurality of
test sites of the consumable; and combinations thereof.
[0071] Still further, the identifier/controller in the assay system
may be used as a security mechanism, e.g., to confirm that the
correct assay consumable is being used in the system (referred to
herein as "consumable security information"). The assay information
may include a digital signature to prove that the consumable was
manufactured by the designated vendor. In one embodiment, if an
inappropriate assay consumable is present in the system, e.g., a
counterfeit consumable or a consumable that is otherwise
incompatible with the assay system, the controller will disable the
system, reader or a component thereof. In addition or
alternatively, the identifier/controller may be used to detect the
proper placement of the assay consumable in the system, e.g., the
proper orientation of the assay consumable or a portion thereof, in
the assay system, such that the controller will disable the system,
reader or a component thereof until the assay consumable is placed
in the correct orientation. Still further, the
identifier/controller in the system may also be used to detect a
defect in the assay consumable or an assay test site and/or domain
and the controller will disable the system, reader or a component
thereof accordingly. For example, depending on the nature of the
defect in the assay consumable or domain, the controller may
disallow the use of the assay consumable in its entirety or direct
the reader to disallow the use of a test site and/or domain or a
set of test site and/or domain in the assay consumable. In one
embodiment, the reader may perform a diagnostic analysis on the
assay consumable and/or a test site and/or domain therein to
identify defects therein and the controller will write the results
of that diagnostic analysis to the identifier on the consumable. If
the consumable is later used in a different reader, the results of
this diagnostic analysis will be read by the controller and used by
the reader to adjust the use of that consumable or a test site
and/or domain in that consumable accordingly. In a further
embodiment, the assay consumable may be subjected to a quality
control process during or after its manufacture and the results of
that quality control analysis may be written to the identifier for
later use and/or verification by the user of the assay consumable
in an assay reader.
[0072] The assay information may also include authorization
information for consumables or test site and/or domain thereof or
biological reagents, such as information regarding whether a
particular user has a valid license to use a particular consumable
or biological reagent, including the number of times the user is
permitted to use the particular consumable or biological reagent in
a particular assay and the limitations, if any, on that use, e.g.,
whether the user's license is for research purposes only. Such
information can also include validation information regarding
whether a particular consumable or biological reagent has been
subject to a recall or has otherwise become unsuitable or
unauthorized for use. The recall information and an optional last
recall check date and/or timestamp can be written to the
identifier.
[0073] The assay information may further include information
regarding the origin of a biological reagent used in an assay
consumable, test site and/or domain, including for example an
identification of an original sample from which it was derived or
the number of generations removed it is from an original sample.
For example, if an assay reagent used in an assay is an antibody,
the assay information may include the identification of the
hybridoma from which the antibody was derived, e.g., the ATCC
accession number for that hybridoma.
[0074] The assay information may additionally include information
regarding a consumable, test site, domain, sector, or a biological
reagent or sample as individual operations are performed on that
consumable, test site, domain, sector, or biological reagent or
sample, for example during manufacture of the consumable, test
site, domain, sector, or biological reagent or while an assay or
step is being performed on the consumable, test site, domain,
sector, or biological reagent or sample. For example, if an assay
consumable includes a plurality of assay test sites, domains,
and/or sectors, the assay system may perform an assay or step of a
multi-step assay on a single test site, domain and/or sector of the
assay consumable. Once that assay or assay step is completed by the
assay system, the controller records the results of that assay,
e.g., the raw or analyzed data generated during the assay or assay
step, to the identifier, and/or the controller records which test
site, domain and/or sector of the assay consumable were used during
the assay or assay step and/or which test site, domain and/or
sector of the assay consumable have yet to be used. The assay
consumable may be stored for later use and when the user is ready
to use another test site, domain and/or sector of the assay
consumable, the controller reads the assay information stored on
the identifier of the assay consumable to identify which test site,
domain and/or sector has been used, has yet to be used, and/or the
results of those assays. The controller may then instruct the assay
system, reader or component thereof to conduct an assay or assay
step on an unused test site, domain and/or sector.
[0075] In addition, a given assay protocol may require a set of
consumables of a particular type. Therefore, if the user inputs a
specific type of assay consumable, e.g., a multi-well assay plate,
for use in a particular assay protocol, one or more additional
assay consumables may be required to carry out that assay protocol
in the system, e.g., one or more reagents may be required for use
with that multi-well assay plate. Each of the required consumables
may include a consumable identifier with information concerning the
consumable requirements for an assay protocol. When one of the
required consumables is input into the assay system and the
identifier controller interacts with the consumable identifier for
that consumable, the system will take an inventory of the
components present in the system and compare the results to the
consumable requirements stored to the consumable identifier. If any
required consumables are not present or are present in insufficient
supply, the system will prompt the user to input the additional
required consumables for that assay protocol based on the
information stored on the required consumable identifier. If two or
more assay consumables are used in the system, the instrument will
correctly identify a first assay consumable and any associated
consumables based on the consumable requirements stored to the
identifiers associated with each consumable. The system will verify
that the assay consumable and associated consumables are loaded on
the system before the sample is run. In the case where only the
first assay consumable is loaded into the system without the
corresponding associated consumable, the system will prompt the
user to load the associated consumable if the instrument does not
identify the associated consumable within the system within a
predefined period of time. The system will notify the user if
mismatched assay consumables are loaded on the instrument. The
system will not run samples if there are no available matched sets
of assay consumables (e.g., multi-well assay plates and given
reagents for a particular assay). The system will check for assay
consumable expiration prior to the start of an assay and the system
will alert the user and prevent the use of an expired consumable.
The system will not process a sample if the consumables have
expired prior to sample aspiration. If a partially used assay
consumable is installed into a different instrument, consumable
usage will automatically start with the next available unused
well.
[0076] The identifier may also be used to track the time a given
assay consumable is present in the assay system. Therefore, when an
assay consumable is inserted into or contacted with an assay
system, a timer is initiated in the assay system and the start time
is recorded to the identifier. When the assay is initiated by the
system on the consumable or a test site, domain and/or sector
within the consumable, the time is also recorded to the identifier.
If the instrument, system or a component thereof is shutdown (e.g.,
by turning the power off), the timer is stopped and that time is
recorded to the identifier. Thus, whenever the timer is stopped,
the accumulated onboard time is recorded to the identifier.
[0077] According to various embodiments, biological samples or
reagents that are provided in the carriers described above are
licensed separately from systems designed to operate on the
biological reagents. In various embodiments the assay system,
reader or a component thereof is coupled to a network that allows
the system to communicate over public and/or private networks with
computer systems that are operated by or on behalf of the users,
manufacturers and/or licensors of the biological reagents,
consumables or systems. In various embodiments, a limited license
can provide for the use of licensed biological reagents,
consumables or systems for a particular biological analysis on only
licensed systems. Accordingly, a system can authenticate a
biological reagent, consumable or system based on, for example, a
digital signature contained in the identifier associated with a
particular consumable, if a particular user has a valid license. In
various embodiments, the identifier can also be programmed to
provide for a one time use such that biological reagents cannot be
refilled for use with the same authentication.
[0078] In certain embodiments, when the identifier is read by a
system, reader or component thereof that has access to a public or
private data network operated by or on behalf of the users,
manufacturers and/or licensors of the biological reagents,
consumables or systems, certain assay information may be
communicated to the assay system and read, write or erased locally
via the identifier/controller on the assay system. For example,
recall and/or license information may be a subset of assay
information that is available via the network connections, whereas
additional assay information e.g., lot-specific, expiration date,
calibration data, consumable specific information, assay domain
information, assay results information, consumable security
information, or combinations thereof, may be stored locally on the
identifier and otherwise unavailable via the network connections on
the assay system. In one embodiment, recall, license and/or
consumable security information may be available via the network
connections on the assay system and the remaining assay information
is stored locally on the identifier. The assay system or reader
includes system hardware, system firmware, system data acquisition
and control software, and method or consumable data. In various
embodiments, the system hardware includes electronic control and
data processing circuitry, such as a microprocessor or
microcontroller, memory, and non-volatile storage. In various
embodiments, the system hardware also includes physical devices to
manipulate biological reagents such as robotics and sample pumps.
In various embodiments, the system firmware includes low-level,
computer-readable instructions for carrying out basic operations in
connection with the system hardware. In various embodiments, the
system firmware includes microprocessor instructions for
initializing operations on a microprocessor in the system
hardware.
[0079] The system data acquisition and control software is
higher-level software that interfaces with the system firmware to
control the system hardware for more specific operations such as
operating a charge coupled device (CCD) to acquire visual
luminescence information regarding a particular biological
analysis. In various embodiments the data acquisition and control
software includes a software-implemented state machine providing,
for example, the following states: (i) idle; (ii) running; (iii)
paused; and (iv) error. In various embodiments, when the state
machine is in the idle state, it can receive an instruction from
the general purpose machine to perform a particular data
acquisition or system control operation. In various embodiments,
the general purpose computer opens a TCP/IP socket connection to
the system, determines whether the system is in the idle state and
then begins transmitting instructions and/or parameters. In various
embodiments, an encrypted TCP/IP connection is established, using,
for example, the SSH protocol. The instructions and/or parameters
can be in the form of ASCII encoded, human readable consumable
and/or method information that defines the behavior of the
biological system. In various embodiments, the consumables and/or
methods are stored in the form of ASCII text files. In various
embodiments, the general purpose computer uses the FTP protocol to
transfer the ASCII text files to the system. In various other
embodiments the method and/or consumable information is stored in
and read from the identifier. The method and/or consumable
information can be stored in the form of an ASCII text file in the
identifier, but it is understood that the information can be
represented in other data formats without departing from the
present teachings.
[0080] According to various embodiments, the consumable, macro,
and/or method information includes parameters that can be used by
the system data acquisition and control software to perform
specific data acquisition and system control operations. In various
embodiments, the method and/or consumable information contains
sequences of operations to be performed by the system or control
parameters for use in connection with the data acquisition or
control software. In one specific embodiment, the assay consumable
is a cartridge as described herein above. The cartridge is provided
with a consumable identifier, e.g., a memory card (which is
supplied with the packaging for the cartridge or a set of a
plurality of cartridges) that includes assay information, e.g., lot
information and/or lot specific parameters. Prior to running an
assay using a cartridge from a new lot of cartridges, the user
inserts the memory card into the reader and uploads the assay
information to the reader's internal memory. The cartridge also
includes an additional consumable identifier, e.g., a bar code,
with the cartridge lot identifier stored thereon. At the beginning
of an assay, the reader loads the cartridge and reads the cartridge
lot identifier from the cartridge barcode using its internal
barcode reader. The reader determines if it has lot specific
information stored for that lot identifier. Then the reader reads
the expiration date from the lot-specific parameters stored in its
internal memory and rejects the cartridge if the on-board clock is
past the expiration date. The reader executes the assay protocol
and determines results based on the lot specific parameters.
[0081] In an alternate embodiment, the assay system uses a
plurality of different assay consumables, e.g., one or more
multi-well assay plates, one or more sample tube racks, and/or
containers for assay reagents. Certain of the consumables used in
the system may be associated with an identifier and others may not.
In one embodiment, each consumable is associated with an
identifier. In one specific embodiment of the invention, an assay
consumable used in the system includes an EEPROM or RFID as a
consumable identifier and the assay system includes a corresponding
EEPROM or RFID controller. The controller detects and uploads the
data stored on the identifier and the system optionally adjusts one
or more assay parameters based on the data uploaded from the
identifier. Once the assay is completed, the identifier controller
writes information to the identifier concerning that assay or the
use of that consumable in the system. The instrument is programmed
to reject any consumable that does not have a readable
identifier.
[0082] The system will prompt the user to scan the reagent
identifiers and will record the scanned information. The system
will also prompt the user to scan the controls, calibrator and
reagent identifiers and record the scanned information. The system
will persistently track the consumable state so that state can be
maintained in the case of a power loss or unexpected shutdown. The
system will estimate the volume of fluids in the reagent bottles
and it will estimate reagent consumption. The system will record
the user identification for the user and that assay information
will be written to the identifier. The system will also record/read
the timestamp when an assay is run to the identifier and it will
allow the user to enter and modify a free text comment before,
during or after the assay is processed, which is also written to
the identifier. The user will input sample identification for each
sample and that assay information is also written to the
identifier.
[0083] In a further embodiment, the assay system uses a plurality
of different assay consumables, e.g., one or more multi-well assay
plates, one or more sample tube racks, and/or containers for assay
reagents. A single assay consumable used in the system may include
a plurality of consumable identifiers, e.g., a first identifier
that includes information that pertains to the entire consumable
and one or more additional consumable identifiers of the same or
different type that includes information that pertains to a
component of that consumable. For example, if the assay consumable
is a sample tube rack, the consumable includes an EEPROM or RFID
with information specific for the entire rack, e.g., lot
information and/or lot specific parameters for the rack. The sample
tube rack may also include two or more additional identifiers,
e.g., a barcode, with information specific for individual samples
and/or positions within the rack, e.g., information concerning the
sample present at a given position in the rack. In addition, the
additional identifier may be used by the system to identify the
presence or absence of a sample or reagent in a given position
within the rack, e.g., if the additional identifier is obscured and
cannot be read by the system, the sample or reagent is present in
the rack and if the additional identifier is read by the system,
the sample or reagent is not present.
[0084] For each type of consumable identifier used by the assay
system there is a corresponding identifier controller. For example,
if the system uses a multi-well assay plate with an EEPROM
identifier and a container for assay reagents with a barcode, then
the system will include an EEPROM controller and a barcode
controller. Each controller detects and uploads the data stored on
a given identifier and the system optionally adjusts one or more
assay parameters based on the data uploaded from that identifier.
Once the assay is completed, the identifier controller writes
information to the identifier concerning that assay or the use of
that consumable in the system. The instrument is programmed to
reject any consumable that does not have a readable identifier.
[0085] The system will prompt the user to scan the reagent
identifiers and will record the scanned information. The system
will prompt the user to scan the controls, calibrator and reagent
identifiers and record the scanned information. The system will
persistently track the consumable state so that state can be
maintained in the case of a power loss or unexpected shutdown. The
system will estimate the volume of fluids in the reagent bottles
and it will estimate reagent consumption.
[0086] In one specific embodiment, the invention provides an assay
system configured to use an assay cartridge in the conduct of an
assay, wherein the assay system comprises a reader adapted to
perform the following operations (i) reading cartridge lot
identification information from a first consumable identifier
associated with the assay consumable; (ii) reading lot specific
parameters from an additional consumable identifier; (iii) using
the lot identification information and the lot specific parameters
to adjust one or more operations performed by the assay system
before, during and/or after the conduct of an assay by the system.
In this embodiment, the 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 the assay; (vi) a cross-talk correction matrix to account for
chemical cross-reactivity; (vi) threshold values for assays to be
conducted in the cartridge; (vii) a range for internal positive
control(s) used in the assay; (viii) a ranges for each assay to be
conducted in the cartridge for a positive control sample; and (ix)
a software checksum. The first consumable identifier comprises
non-volatile memory, e.g., an RFID tag, a bar code, ICC, an EPROM,
and EEPROM. In one embodiment, the non-volatile memory is a bar
code. The additional consumable identifier also comprises
non-volatile memory, e.g., an RFID tag, a bar code, ICC, an EPROM,
and EEPROM. In one embodiment, the additional consumable identifier
is an ICC, e.g., a memory card.
[0087] Therefore, an assay procedure using an assay consumable
cartridge in an assay system, e.g., an assay reader, includes
inserting the cartridge in the reader to allow the identifier
controller to interact with the identifier affixed to or associated
with the cartridge. Alternatively, the cartridge packaging includes
the identifier affixed thereto or associated therewith and before
the cartridge is inserted into the reader, the identifier of the
cartridge packaging is contacted with the identifier controller.
The identifier controller associated with the reader reads the
cartridge lot identification information from the first consumable
identifier as well as the lot specific parameters from any
additional consumable identifier. The reader then uses the lot
identification information and the lot specific parameters to
adjust one or more operations performed by the reader before,
during and/or after the conduct of an assay. For each lot specific
parameter, the reader may adjust the system or output accordingly.
Thereafter, the reader makes the appropriate electrical, fluidic
and/or optical connections to the cartridge (making use of
electrical, fluidic and/or optical connectors on the cartridge and
reader) and conducts an assay in the cartridge. The sample may be
introduced into the cartridge prior to inserting the cartridge in
the reader. The assay may also involve adding one or more assay
reagents to the cartridge and instructions for adding those various
assay reagents may be saved to the identifier and the reader adds
those reagents to the cartridge before or during the assay
according to the instructions saved to the assay consumable
identifier.
[0088] In another specific embodiment, the invention provides an
assay system configured to use a multi-well assay plate, an
additional multi-well assay plate (referred to as an auxiliary
plate), and one or more sample tube racks in the conduct of an
assay, wherein the assay system comprises a reader adapted to
perform one or more of the following operations (i) reading tube
position information from a first consumable identifier associated
with the one or more sample tube racks; (ii) reading assay
information and lot specific parameters from an additional
consumable identifier associated with the auxiliary plate; (iii)
using position information and lot specific parameters to adjust
one or more operations performed by the assay system before, during
and/or after the conduct of an assay using the multi-well assay
plate and the auxiliary plate; (iv) erasing information from a
consumable identifier; and (v) writing information to a consumable
identifier. In one embodiment, the assay information is selected
from the group consisting of (i) a digital signature to verify
manufacturer identify; (ii) lot code of the multi-well assay plate
and/or the auxiliary plate; (iii) expiration date of the multi-well
assay plate and/or the auxiliary plate; (iv) type of multi-well
assay plate and/or the auxiliary plate; (v) serialized
identification for the auxiliary plate; and (vi) lot specific
parameters for the multi-well assay plate and/or the auxiliary
plate. Still further, the lot specific parameters for the
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 the multi-well assay plate; and (xi)
combinations thereof. The first consumable identifier may comprise
non-volatile memory, e.g., an RFID tag, a bar code, ICC, an EPROM,
and EEPROM. In one embodiment, the non-volatile memory is a bar
code. The additional consumable identifier comprises non-volatile
memory, e.g., an RFID tag, a bar code, ICC, an EPROM, and EEPROM.
In one embodiment, the additional consumable identifier is an
EEPROM or an RFID.
[0089] Reference is made to copending U.S. Provisional Patent
Application Ser. No. 61/271,874, filed Jul. 27, 2009 (docket number
120000USPR00), the disclosure of which is incorporated herein by
reference. In one embodiment, a method of using such an assay
system includes (a) introducing a sample tube rack into a sample
rack subassembly; (b) reading sample and assay-specific information
from the identifiers on the sample rack subassembly and/or reading
sample and assay-specific information manually input into the
computer user interface by the user; (c) introducing an auxiliary
plate to an auxiliary plate subassembly; (d) reading assay-specific
information from the identifiers on the auxiliary plate; (e)
introducing an assay test plate into a plate introduction aperture
of a light-tight enclosure of the apparatus; (f) reading
assay-specific information from the identifiers on the assay test
plate; (g) sealing the door of the plate introduction aperture, (f)
translating the test plate to position one or more wells under a
light detector, (g) rehydrating reagents in one or more auxiliary
wells of the auxiliary plate using a pipetting arm subassembly
and/or pretreating one or more wells of the test plate using the
pipetting arm subassembly; (h) collecting a sample volume from a
sample tube of the sample rack subassembly and pipetting that
sample volume into a well of an assay test plate; (i) collecting
sample reagents from the auxiliary plate and dispensing those
reagents into a well of the assay test plate; (j) detecting
luminescence from the one or more wells, (k) repeating one or more
of the preceding steps on additional wells of the test plate, using
additional auxiliary wells of the auxiliary plate; (j) translating
the used test plate to a plate elevator; (k) raising the plate
elevator; and (l) removing the test plate from the plate
introduction aperture.
[0090] The method may also, optionally, comprise one or more of: i)
pre-treating sample and/or reagent in a auxiliary well of the
auxiliary plate and pipetting that pre-treated sample and/or
reagent into or out of one of a auxiliary well of a test plate; ii)
removing seals from one or more of the auxiliary wells and/or wells
of the auxiliary plate and/or test plate, respectively, or iii)
applying electrical energy to electrodes in one or more of said
test plate wells (e.g., to induce electrochemiluminescence).
[0091] One assay procedure using an assay consumable, e.g., a
multi-domain multi-well plate, and an assay system would comprise
inserting the consumable in the system to allow the identifier
controller to interact with the identifier affixed to or associated
with the consumable. Alternatively, the consumable packaging
includes the identifier affixed thereto or associated therewith and
before the consumable is inserted into the system, the identifier
associated with the consumable packaging is contacted with the
identifier controller. The system may adjust the assay parameters
prior to initiating an assay based on the assay information saved
to the identifier. Thereafter, the system makes the appropriate
electrical, fluidic and/or optical connections to the consumable
(making use of electrical, fluidic and/or optical connectors on the
consumable and system) and conducts an assay using the consumable.
The sample may be introduced into the consumable prior to inserting
the consumable in the system. Alternatively, the sample is
introduced by a component of the system after the consumable is
inserted in the system. The assay may also involve adding one or
more assay reagents to the consumable and instructions for adding
those various assay reagents may be saved to the identifier and the
system adds those reagents to the consumable before or during the
assay according to the instructions saved to the assay consumable
identifier.
[0092] The present invention is not to be limited in scope by the
specific embodiments described herein. Indeed, various
modifications of the invention in addition to those described
herein will become apparent to those skilled in the art from the
foregoing description and accompanying figures. Such modifications
are intended to fall within the scope of the claims. Various
publications are cited herein, the disclosures of which are
incorporated by reference in their entireties.
* * * * *