Consumables data integration management system and platform

Abstract

This invention relates to methods, devices, and systems for associating consumable data with assay consumables used in biological assays. [Solution] Provided are an assay system 204 and associated consumables 202, the assay system 204 adjusting one or more steps of the assay protocol based on consumable data specific to the consumables 202. Various types of consumable data and methods for using such data in performing assays with the assay system 204 are also described. The present invention also relates to consumables 202 (e.g., kits and reagent containers), software, data expandable bundles, computer-readable media, loading carts, instruments, systems, and methods for performing automated biological assays.

Claims

1. An assay system configured to use assay consumables in the execution of an assay, wherein the assay consumables include an assay consumable identifier that includes an assay consumable identifier comprising a data expandable bundle (DBB) for the assay consumables, (a) A storage medium including a consumables data repository and a data registry that contain local consumables data, (b) A consumables identifier controller adapted to read the DDB and install it into the storage medium, (c) A consumable data service processor adapted to query the data registry and one or more remote consumable data databases in order to use the assay consumables and identify and download the consumable data required for the execution of the assay by the assay system. The assay system comprising the above-mentioned features.

2. The assay system according to claim 1, wherein the consumable identifier is further configured to persist one or more data files of the DDB in the storage medium.

3. The assay system according to claim 2, wherein one or more data files comprise a DDB unique identifier, a DDB version, consumable static information, consumable processing information, and a combination thereof.

4. The assay system according to claim 2, wherein one or more data files include a DDB unique identifier, a DDB version, and consumable static information.

5. The assay system according to claim 3 or 4, wherein the static consumable information comprises consumable type information.

6. The assay system according to claim 5, wherein the consumable is a multiwell assay plate, and the consumable type information includes the number of columns of wells, the number of rows of wells, the number of binding domains per well, and combinations thereof.

7. The assay system according to claim 3, wherein the consumable is a multiwell assay plate, and the consumable processing information comprises data used by the assay system in the execution of an assay using the plate and / or processing of assay data resulting from the execution of an assay using the plate.

8. The assay system according to claim 7, wherein the consumable processing information comprises the number of sectors per plate, the number of circuits per plate, detection parameters used by the assay system to read the plate, image processing characteristics used to produce ECL results, plate type gain, binding domain gain, optical crosstalk matrix, and combinations thereof.

9. The assay system according to claim 3, wherein the assay consumables are a kit comprising a multiwell assay plate and one or more reagents used in the execution of the assay using the plate, and the DDB comprises assay binding domain information, assay protocol, data analysis parameters, product inserts, and combinations thereof.

10. The assay system according to any one of claims 1 to 9, further comprising a DDB version compatibility processor configured to downgrade and / or upgrade incompatible DDB software.

11. The assay system according to any one of claims 1 to 10, further comprising a DDB factory adapted to convert unprocessed classification data into assay system configuration data suitable for use by the assay system in the performance of the assay.

12. The assay system according to any one of claims 1 to 11, wherein the DDB comprises a DDB xml file containing data description information and data processing information.

13. A data-extractable bundle (DDB) comprising one or more data files containing assay consumables and consumable data relating to the use of assay consumables in an assay system, wherein the one or more data files comprise a DDB unique identifier, a DDB version, a DDB XML file, consumable static information, consumable processing information, and a combination thereof.

14. The DDB according to claim 13, wherein one or more data files include a DDB unique identifier, a DDB version, a DDB XML file, and consumable static information.

15. The DDB according to claim 13 or 14, wherein the static consumable information comprises consumable type information.

16. The DDB according to claim 15, wherein the consumable is a multiwell assay plate, and the consumable type information includes the number of columns of wells, the number of rows of wells, the number of binding domains per well, and combinations thereof.

17. The DDB according to claim 13, wherein the consumable is a multiwell assay plate, and the consumable processing information comprises data used by the assay system in the execution of an assay using the plate and / or processing of assay data resulting from the execution of an assay using the plate.

18. The DDB according to any one of claims 13, 15, or 17, wherein the consumable processing information comprises the number of sectors per plate, the number of circuits per plate, detection parameters used by the assay system to read the plate, image processing characteristics used to produce ECL results, plate type gain, binding domain gain, optical crosstalk matrix, and combinations thereof.

19. The DDB according to any one of claims 13 to 18, wherein the assay consumable is a kit comprising a multiwell assay plate and one or more reagents used in the execution of the assay using the plate, and the DDB further comprises assay binding domain information, assay protocol, data analysis parameters, product inserts, and combinations thereof.

20. The DDB according to any one of claims 13 to 19, wherein the DDB XML file includes data description information and data processing information.

21. A computer-readable medium for storing a computer program in which, when executed by a computer system connected to the assay system in an operable manner, the assay system is configured to use assay consumables in the execution of the assay, the assay consumables comprising an assay consumable identifier including the DDB described in claim 13, and the assay system (a) A storage medium including a consumables data repository containing local consumables data and a data registry, (b) A consumables identifier controller adapted to read the DDB and install it into the storage medium, (c) A consumable data service processor adapted to query the data registry and one or more remote consumable databases in order to identify and download consumable data required for the execution of the assay by the assay system using the assay consumables. Equipped with, The method described above is (a) The step of reading the DDB from the consumable identifier, (b) The step of storing the DDB in the consumables data repository, (c) The steps of identifying consumable data from the consumable data repository and downloading consumable data from one or more remote consumable data databases of any choice, (d) A step of coordinating one or more actions performed by the system before, during, and / or after the execution of the assay based on the consumable data, (e) The step of performing the assay using the assay consumables and the assay system. Computer-readable media, including [specific examples of computer-readable media].

22. The computer-readable medium according to claim 21, further comprising the step of sustaining one or more data files of the DDB on the storage medium.

23. A holder for assay reagents, At least two regions configured to receive at least one or two reagent containers, The reagent container has at least one or two holes or windows configured to allow viewing of at least one or two consumable identifiers located at the bottom of the container. A holder equipped with the following features.

24. The holder according to claim 23, wherein the region has at least two different sizes for receiving at least two assay containers of different sizes.

25. The holder according to claim 23, wherein the region and the hole or window are circular, and the diameter of the hole or window is smaller than that of the region.

26. The holder according to claim 23, wherein the region and the hole or window are linear, and the diameter of the hole or window is smaller than that of the region.

27. The holder according to claim 23, comprising a frame, at least one optional insert, and at least one optional mask.

28. The holder according to claim 27, wherein the mask is attached to the upper part of the frame.

29. The holder according to claim 27 or 28, wherein the insert is positioned within the frame and below the mask.

30. The holder according to any one of claims 27 to 29, wherein at least two of the holes are holes in the frame.

31. The holder according to any one of claims 27 to 30, wherein the at least two regions comprise a cylindrical hole in the frame, or the optional insert, or both.

32. The holder according to any one of claims 27 to 31, wherein at least two of the aforementioned regions have holes within the mask.

33. The holder according to any one of claims 27 to 32, wherein at least two of the holes are transparent plastic-coated holes in the frame.

34. The holder according to any one of claims 27 to 33, wherein the installation area dimensions of the container conform to the ANSI-SLAS dimensions for a multiwell plate.

35. The holder according to any one of claims 27 to 34, wherein the height of the container conforms to the ANSI-SLAS height for a multiwell plate.

36. The holder according to any one of claims 27 to 35, wherein the insert is made of foam and is inserted into at least a cylindrical hole in the frame for filling the at least two reagent containers.

37. The holder according to any one of claims 27 to 35, wherein the insert is positioned between the reagent container and an area larger than the reagent container.

38. The holder according to any one of claims 27 to 35, wherein the insert is a foam, defines the cylindrical hole in the assay reagent container, and fills the frame.

39. The holder according to any one of claims 27 to 38, wherein the mask defines a plurality of regions, and the number of mask regions is the same as or less than the number of regions of the container, frame, or insert.

40. The holder according to any one of claims 27 to 39, wherein the mask limits the number of assay containers that are received by the assay reagent container.

41. The holder according to any one of claims 27 to 40, wherein the mask is provided with a label for reagents.

42. The holder according to any one of claims 23 to 41, further comprising an assay consumable identifier that can be attached thereon.

43. The holder according to claim 42, wherein the assay consumable identifier is located on the bottom, side, or top of the container.

44. The holder according to any one of claims 23 to 43, further comprising at least one of the reagent containers.

45. The holder according to claim 44, wherein the reagent container comprises an assay reagent.

46. The holder according to claim 45, wherein the assay reagent is a reagent for a V-PLEX assay, a U-PLEX assay, an immunogenicity (IG) assay, a pharmacokinetic (PK) assay, or a custom assay.

47. The aforementioned label is used for V-PLEX assay, U-PLEX assay, and immunogenicity (IG) assay. A holder according to any one of claims 41 to 46, defining an assay reagent for a pharmacokinetic (PK) assay or a custom assay.

48. The holder according to any one of claims 23 to 47, wherein the assay reagent container or the frame is made of conductive plastic.

49. The holder according to any one of claims 23 to 48, further comprising a lid.

50. The holder according to claim 49, wherein the lid is completely or largely transparent.

51. The holder according to claim 49, wherein at least one or two assay containers are provided with an assay consumable identifier located at the bottom thereof and visible from the bottom of the container.

52. (a) A frame having a bottom and sides, wherein the bottom is rectangular in shape, has dimensions conforming to the ANSI-SLAS standard, and defines the holder hole or window, (b) an insert having an insert hole made to a size that holds a tube or vial, and which fits into the frame positioned so as to align the tube or vial with the hole or window of the holder, (c) A mask positioned above the insert, wherein the mask holes are aligned with the insert holes, allowing the insertion of a tube or vial into the insert, and the mask also provides identification information about the tube or vial. (d) Optionally, a lid for sealing the vial inside the holder A holder according to any one of claims 23 to 52, comprising:

54. The holder according to any one of claims 23 to 53, wherein the consumable identifier is a two-dimensional barcode.

55. The holder according to claim 54, wherein the two-dimensional barcode is printed on a plastic pack that is inserted into the recess at the bottom of the tube or vial.

56. The holder according to claim 54, wherein the two-dimensional barcode is printed on a foil disc that is heat-sealed to the recess at the bottom of the tube or vial.

57. The assay tube or vial contains the following assay reagents (i) Calibration material and, (ii) Comparison material and, (iii) Capture reagent and, (iv) Detection reagent, (v) Diluted solution and, (vi) Linker's reagent A holder according to any one of claims 23 to 56, comprising a tube or vial having one or more of the above.

58. An assay kit comprising the assay container described in any one of claims 23 to 57 in a cardboard container.

59. The kit according to claim 58, further comprising an assay consumable identifier in the cardboard container.

60. Claim 5, further comprising at least one assay consumable plate in the cardboard container. The kit described in 8 or 59.

61. The kit according to claim 60, wherein the assay consumable plate is a multiwell assay plate.

62. The kit according to claim 60 or 61, wherein the assay consumable plate comprises an assay consumable identifier.

63. The kit according to any one of claims 58 to 62, further comprising at least one trough or tube or both.

64. A lid configured to cover the upper surface of a multiwell plate, comprising a skirt dependent on the upper part of the lid, wherein the skirt is adapted to fit around the outer circumference of the upper surface of the multiwell plate, and the upper surface of the plate is made to be of a size and dimensions that contacts the outer circumference of the multiwell plate. Multiple indentations extend from the upper part of the lid toward the multiwell plate. lid.

65. The lid according to claim 64, wherein the plurality of recesses correspond to the plurality of wells of the multiwell plate.

66. The lid according to claim 65, wherein the plurality of recesses are configured to extend into the plurality of wells.

67. The lid according to claim 65, wherein the upper surface of the lid is adapted to contact the upper lip of at least one of the plurality of wells.

68. A lid according to any one of claims 64 to 67, which is not made from an adapted plastic or elastomer material.

69. A lid made from hard plastic, according to any one of claims 64 to 68.

70. The lid according to claim 69, made from polystyrene.

71. A lid configured to cover the upper surface of a multiwell plate, comprising a skirt dependent on the upper part of the lid, wherein the skirt is adapted to fit around the outer circumference of the upper surface of the multiwell plate, and the upper surface of the plate is made to be of a size and dimensions that contacts the parameters of the multiwell plate. The aforementioned lid is optionally hydrophobic. lid.

72. The lid according to claim 71, wherein the lid is made of a hydrophobic polymer.

73. The lid according to claim 71, wherein the bottom surface of the upper part of the lid is made hydrophobic.

74. The lid according to claim 73, wherein the bottom surface is micro-etched to create a rough surface for trapping air, thereby causing the bottom surface to exhibit Cassie-Baxter behavior as a barrier to moisture.

75. The lid according to claim 71, wherein the bottom surface is coated with a hydrophobic coating.

76. The lid according to claim 71, wherein the bottom surface is coated with a surfactant.

77. The lid according to claim 71, further comprising a plurality of recesses extending from the upper part of the lid toward the multiwell plate.

78. The lid according to claim 77, wherein the plurality of recesses correspond to the plurality of wells of the multiwell plate.

79. The lid according to claim 78, wherein the plurality of recesses are configured to extend within the plurality of shells.

80. A lid according to any one of claims 64 to 79, which is not made from an adapted plastic or elastomer material.

81. A lid made from hard plastic, according to any one of claims 64 to 80.

82. The lid according to claim 81, made from polystyrene.

83. A lid configured to be attached to a reagent container, adapted for a probe to enter and exit, having a top surface, the top surface having a pattern of cuts separating the top surface into segments, the segments bending downward when the probe enters the reagent container and returning to their original orientation when the probe exits.

84. The lid according to claim 83, wherein the probe comprises at least one pipette tip.

85. The lid according to claim 83 or 84, wherein the pattern of cuts comprises at least one curved line.

86. The lid according to claim 83 or 84, wherein the pattern of cuts comprises at least one meandering line.

87. The lid according to claim 83 or 84, wherein the pattern of cuts comprises at least one substantially ring-shaped line.

88. The lid according to claim 83 or 85, wherein the pattern of cuts comprises parallel straight lines.

89. The lid according to any one of claims 83 to 88, wherein the lid is made from a non-elastomer material.

90. The lid according to any one of claims 83 to 88, wherein the lid is made from an elastomer material.

91. A lid according to any one of claims 83 to 90, for covering a reagent trough.

92. A loading cart adapted for use with an assay system, wherein the loading cart comprises a computer screen and a movable body having at least one shelf and a support for the computer screen, The shelf comprises at least one tray, the tray having a plurality of elongated holes, the elongated holes being sized and sized to receive a plurality of consumables for performing an assay, The computer screen is adapted to display a user interface showing a first arrangement of the plurality of containers of consumables on at least one tray. Loading cart.

93. The loading cart according to claim 92, wherein the computer screen is the screen of a tablet computer.

94. The loading cart according to claim 92, wherein the computer screen is connected to a personal computer or laptop computer.

95. The loading cart according to any one of claims 92 to 94, wherein the computer screen is controlled by a processor on the assay machine.

96. The loading cart according to claim 95, wherein the computer screen is connected to the processor on the assay machine via a Wi-Fi connection or a Bluetooth connection.

97. The loading cart according to claim 92, wherein the plurality of elongated holes are defined on the upper surface of at least one tray.

98. The loading cart according to claim 97, wherein a plurality of elongated holes are also defined on the bottom surface of at least one of the trays.

99. The loading cart according to any one of claims 92, 97, or 98, wherein the plurality of slots comprises slots of different sizes adapted to receive the plurality of consumables of different sizes.

100. The loading cart according to claim 92, wherein the support for the computer screen is an adjustable support.

101. The loading cart according to claim 100, wherein the adjustable support is rotatable substantially around a vertical axis.

102. The loading cart according to claim 101, wherein the adjustable support is further tiltable around an axis substantially perpendicular to the vertical axis.

103. The loading cart according to claim 92, wherein at least one of the shelves is an upper shelf.

104. The loading cart according to claim 103, further comprising a bottom shelf.

105. The loading cart according to claim 103, further comprising a central shelf.

106. The loading cart according to claim 92, further comprising a compartment below the at least one tray, wherein the compartment is adapted for storing coolant.

107. The loading cart according to claim 106, wherein the compartment is provided with a drain.

108. The loading cart according to claim 106, wherein the bottom surface of the compartment is concave.

109. The loading cart according to any one of claims 92 to 108, wherein the movable body is supported by at least one caster wheel.

110. The loading cart according to claim 109, wherein at least one of the caster wheels is a hubless caster wheel.

111. The loading cart according to any one of claims 92 to 110, wherein the plurality of consumables comprises at least one multiwell plate.

112. The loading cart according to claim 111, wherein the at least one multiwell plate comprises at least one assay plate or at least one dilution plate.

113. A loading cart according to any of claims 92 to 112, wherein the plurality of consumables comprises at least one container of reagents.

114. The loading cart according to any one of claims 92 to 113, wherein the plurality of consumables comprises at least one tube.

115. The loading cart according to any one of claims 92 to 113, wherein the plurality of consumables comprises at least one trough.

116. The loading cart according to any one of claims 92 to 115, wherein the tray is configured as shown in Figure 19.

117. A loading cart according to any one of claims 92 to 116, comprising a mobile computer bequest associated with the aforementioned computer screen.

118. An assay preparation system for preparing assay components, (a) an assay system having a processor that provides information about the components required to perform an assay run, (b) A loading cart having shelves for assembling components used in the assay, and supports for holding mobile computing devices, (c) Mobile computing devices including computer screens and Equipped with, The mobile computing device includes networking capabilities for accessing the information via the processor, and a graphical user interface for presenting the information to the user on a computer screen and guiding the placement of assay components in the loading cart. Assay preparation system.

119. The preparation system according to claim 118, wherein the loading cart is the loading cart according to any one of claims 92 to 117.

120. The preparation system according to claim 118 or 119, wherein the loading cart further comprises a consumable identifier reader, and the graphical user interface is configured to use the reader when placing assay components on the cart, to accept identifier information provided by the user, to use the information to verify the validity of the components, and to transfer the identification information to the processor.

121. A method for instructing a user to load consumables onto an assay system, comprising using the loading cart described in any of claims 92 to 117.

122. The method according to claim 121, further comprising arranging a plurality of consumables in the loading station according to a first arrangement displayed on the screen by a user interface.

123. A method for loading consumables for performing an assay into an assay system, a. The step of receiving multiple consumables, b. The step of arranging the plurality of consumables in the intermediate consumable loading station according to a first configuration displayed by a user interface on a screen positioned in the intermediate consumable loading station, c. The step of moving the intermediate consumable loading station to the assay system, d. A method comprising the step of transferring the plurality of consumables to the assay system according to a second configuration, wherein the first configuration is substantially the same as the second configuration.

124. The method according to claim 123, wherein the intermediate consumable loading station includes a movable cart.

125. The method according to claim 124, wherein the screen is a computer screen.

126. The method according to claim 125, wherein the computer screen is movably attached to the cart.

127. The method according to claim 126, wherein the computer screen is substantially rotatable around a vertical axis.

128. The method according to claim 127, wherein the computer screen is further tiltable with respect to the vertical axis.

129. The method according to any one of claims 123 to 128, further comprising the step of cooling at least one of the plurality of consumables.

130. The method according to claim 124, wherein step (b) includes the step of placing the plurality of consumables into a plurality of elongated holes defined on the upper surface of the movable cart.

131. The method according to any one of claims 123 to 131, wherein the plurality of consumables comprises at least one multiwell plate or at least one reagent container.

132. The method according to any one of claims 124 to 131, wherein the movable cart is the loading cart according to any one of claims 92 to 117.

133. A plate manufactured to the size and dimensions of an ANSI-SLAS format assay plate, comprising a rectangular outer perimeter and at least one support member connecting a first side of the rectangular outer perimeter to a second side of the outer perimeter, wherein at least one reference pad is located on the first main surface of the plate and corresponds to the location of at least one well of the ANSI-SLAS format assay plate, A plate in which the location of at least one reference pad in one dimension of a three-dimensional coordinate system is measurable by a probe of the assay system when the plate is positioned on the plate carrier of the assay system.

134. The plate according to claim 133, wherein the probe measures the capacitance between the probe and the at least one reference pad.

135. The plate according to claim 134, wherein the plate is conductive.

136. The plate according to claim 133, wherein the ANSI-SLAS format assay plate is an 8x12 multiwell plate, and the at least one reference pad corresponds to a corner well on the ANSI-SLAS format assay plate.

137. The plate according to claim 133, further comprising at least two opposing gripping regions located on the side connecting two main surfaces of the plate, wherein the gripping regions are adapted to be gripped by a gripper arm of a robotic system.

138. The plate according to claim 133 or 137, wherein the rectangular perimeter adjacent to the first main surface is smaller than the rectangular perimeter adjacent to the second main surface, and the first main surface and the second main surface are substantially parallel.

139. The plate according to any one of claims 133 to 138, wherein the plate is made from cast aluminum.

140. The plate according to any one of claims 133 to 138, wherein the plate is machined from cast aluminum.

141. A method for training or instructing a robotic gripper or pipette, comprising using the plate according to any one of claims 133 to 139.

142. A method for training or instructing a robotic gripper, and the following: The steps include commanding the robot gripper arm to move to a specific location in the X, Y, and Z spaces corresponding to the region on the plate, The steps include: commanding the robot gripper arm to rotate to a specific location corresponding to a region on the plate; The steps of commanding the robotic gripper arm to open or close the gripper to a specific width or length corresponding to a region on the plate, A step of using the specific location of the gripper arm relative to the plate to estimate the fixed location throughout the entire automated setup, To calculate the robot training positions of the aforementioned location and other related parts of the experimental apparatus, the step is to use the specific location of the gripper arm relative to the plate, and The method according to claim 141, comprising at least one of the following.

143. The following steps The steps include: instructing the automatic dispensing arm to move to a specific location in the X, Y, and Z spaces corresponding to the region on the plate; A step of using the specific location of the automatic dispensing arm relative to the plate to estimate the fixed location throughout the entire automatic setup, To calculate the robot training positions of the aforementioned location and other related parts of the experimental apparatus, the steps include using the specific location of the automatic dispensing arm relative to the plate, and The method according to claim 141, comprising a method for training or instructing the automated dispensing arm, comprising at least one of the following.

144. A method for training a robot-controlled probe in an assay system, A step of positioning a plate in a plate carrier inside the assay system, wherein the plate is made to a size and dimensions that match the size and dimensions of an assay plate in the ANSI-SLAS format, and the position of the plate is known in a three-dimensional coordinate system. A step of moving the robot-controlled probe toward a reference pad on the plate, wherein the reference pad corresponds to a well of the ANSI-SLAS plate. A step of obtaining a first location of the reference pad using the capacitance between the probe and the reference pad in the three-dimensional coordinate system, The steps of assigning the first location as one dimension in the three-dimensional coordinate system for the robot-controlled probe: Methods that include...

145. The method according to claim 144, wherein the plate is the plate according to any one of claims 133 to 140.

146. An assay consumable storage unit adapted to be mounted on a platform of an assay system comprising a base and a shelf assembly having multiple sets of vertically aligned storage units, wherein each storage unit is made to be of a size and dimensions to receive consumables for the execution of assays by the assay system, The shelf assembly comprises a plurality of horizontal members connected by a plurality of upright vertical supports, The base is cantilevered to the platform, and the shelf assembly is removably attached to the base by at least two positioning pins and at least one screw-type connector having a finger-operable head. Assay consumables storage unit.

147. The apparatus according to claim 146, wherein the shelf assembly comprises an M x N linear array of vertically aligned storage units, where M and N are integers.

148. The apparatus according to claim 146, wherein the upper horizontal member has alignment features for a container bottom conforming to ANSI SLAS.

149. The apparatus according to any one of claims 146 to 148, wherein the upper horizontal member has alignment features for a lid of an assay reagent holder that is larger than the bottom of the container in accordance with ANSI SLAS.

150. The apparatus according to claim 149, wherein the assay reagent holder is the assay reagent holder described in any one of claims 23 to 57.

151. Assay system comprising a housing, wherein the housing includes a continuous glass member, a touchscreen for a computer screen is formed by a first portion of the continuous glass member and an array of pressure transducers, and a sound emitter is formed by a second portion of the continuous glass member and at least one sound exciter.

152. An automated assay system adapted to receive consumables in the execution of the assay, wherein the assay system includes a robot-controlled pipette and robot-controlled gripper arm, an assay reader, a plate washer, and at least one optional heatable shaker, at least one heat exchanger, and in loading and receiving the consumables. It comprises at least one processor adapted to execute at least one instruction that minimizes potential errors in the execution of the Say, The consumables comprise a plurality of containers, each containing at least one assay test plate, at least one dilution plate, at least one set of pipette tips, at least one sample plate, and at least one of a calibrator, diluent, and antibody. The aforementioned at least one instruction is as follows: Instructions to the user interface that guide the user in loading the aforementioned consumables into the assay system, When the at least one assay test plate is placed in the shaker, a command is given to the robot gripper arm to place a lid on the at least one assay test plate, A command to the at least one heat exchanger to maintain a selected temperature within the assay system, An instruction to perform the assay for at least one assay test plate, wherein the at least one assay plate comprises a plurality of assay test plates, and each assay test plate is completed substantially in the same time period; including at least one of the following: Automated assay system.

153. The automated assay system according to claim 152, wherein the command to the user interface includes a command to load consumables from a kit.

154. The automated assay system according to claim 152, wherein the command to the user interface includes a command to load consumables into an intermediate consumable loading station.

155. The automated assay system according to claim 154, wherein the intermediate consumable loading station includes a movable cart.

156. The automated assay system according to any one of claims 152 to 154, wherein the at least one command further comprises a command to the robot-controlled pipette to use a training plate and obtain its vertical position.

157. The automated assay system according to claim 156, wherein the command to the robot-controlled pipette further includes a command to obtain its horizontal position.

158. The automated assay system according to any one of claims 152 to 157, wherein the at least one command further comprises a command to the robot-controlled gripper arm to use a training plate and obtain its vertical position.

159. The automated assay system according to claim 158, wherein the command to the robot-controlled pipette further includes a command to obtain at least one position in the horizontal plane.

160. The automated assay system according to any one of claims 152 to 159, wherein the at least one instruction further comprises an instruction for performing a qualification procedure.

161. The automated assay system according to any one of claims 152 to 160, wherein the assay reading device is an ECL reading device.

162. The aforementioned qualification procedure is as follows: (i) A step of verifying the ECL reader, (ii) A step to confirm the suction function of the plate washing machine, (iii) A step to confirm the weighing and dispensing function of the plate washing machine, (iv) A step to confirm the metering and dispensing function of the pipette and An automated assay system according to claim 161, comprising at least one of the following.

163. The confirmation of the ECL reader is as follows: (a) The step of reading the electronic plate using the ECL reader in order to confirm the flow of current in the ECL reader, (b) The step of reading an empty assay test plate using the ECL reader in order to check for background electrical noise, (c) A step of reading an assay test plate, wherein the wells in the plate are filled with free tag buffer to ensure that the ECL reader reads the expected count. An automated assay system according to claim 162, comprising at least one of the following.

164. The automated assay system according to any one of claims 152 to 163, wherein the at least one processor executes at least two instructions.

165. The automated assay system according to any one of claims 152 to 164, wherein the at least one processor executes at least three instructions.

166. The automated assay system according to any one of claims 152 to 165, wherein the at least one processor executes at least four instructions.

167. The automated assay system according to claim 154, wherein the movable cart is the loading cart according to any of claims 92 to 117.

168. A method for loading consumables for an assay and operating an automated assay system to minimize potential errors when performing the assay, The assay system includes a robot-controlled pipette and robot-controlled gripper arm, an assay reader, a plate washer, and at least one shaker and incubator, at least one heat exchanger, and at least one processor. The assay system is adapted to receive consumables, the consumables comprising at least one assay test plate, at least one dilution plate, at least one set of pipette tips, at least one sample plate, and a plurality of containers containing at least one of a calibrator, control, diluent, antibody, reagent, and buffer, The aforementioned method is as follows: The steps include: instructing the user interface to instruct the user to load the consumables into the assay system; When the at least one assay test plate is placed in the shaker and the incubator, the robot gripper arm is instructed to place a lid on the at least one assay test plate. The steps include instructing at least one heat exchanger to maintain a temperature selected within the assay system, A step of instructing the at least one processor to run the assay for the at least one assay test plate, wherein the at least one assay plate comprises a plurality of assay test plates, and each assay test plate is completed substantially in a synchronous period. A method that includes at least one of the following.

169. The method according to claim 168, wherein the assay reading device is an ECL reading device.

170. The method according to claim 168 or 169, wherein the command to the user interface includes a command to load consumables from the kit.

171. The method according to any one of claims 168 to 170, wherein the command to the user interface includes a command to load consumables into an intermediate consumable loading station.

172. The method according to any one of claims 168 to 171, wherein the intermediate consumable loading station comprises a movable cart.

173. The method according to any one of claims 168 to 172, wherein the at least one instruction further comprises an instruction to the robot-controlled pipette to use a training plate and obtain its vertical value.

174. The method according to any one of claims 168 to 173, wherein the command to the robot-controlled pipette further includes a command to obtain its horizontal position.

175. The method according to any one of claims 168 to 174, wherein the at least one instruction further comprises an instruction to the robot-controlled gripper arm to use a training plate and obtain its vertical position.

176. The method according to claim 175, wherein the command for the robot-controlled pipette further includes a command to obtain at least one position in the horizontal plane.

177. The method according to any one of claims 168 to 176, wherein the at least one instruction further comprises an instruction for performing a qualification procedure.

178. The method according to any one of claims 168 to 177, wherein the assay reading device is an ECL reading device.

179. The aforementioned qualification procedure is as follows: (i) A step of verifying the ECL reader, (ii) A step to confirm the suction function of the plate washing machine, (iii) A step to confirm the weighing and dispensing function of the plate washing machine, (iv) A step to confirm the metering and dispensing function of the pipette and The method according to claim 177, comprising at least one of the following.

180. The confirmation of the ECL reader is as follows: (a) The step of reading the electronic plate using the ECL reader in order to confirm the flow of current in the ECL reader, (b) The step of reading an empty assay test plate using the ECL reader in order to check for background electrical noise, (c) A step of reading an assay test plate, wherein the wells in the plate are filled with free tag buffer to ensure that the ECL reader reads the expected count. The method according to claim 179, comprising at least one of the following.

181. The method according to any one of claims 168 to 180, wherein the at least one processor executes at least two instructions.

182. The method according to any one of claims 181, wherein the at least one processor executes at least three instructions.

183. The method according to any one of claims 182, wherein the at least one processor executes at least four instructions.

184. The method according to any one of claims 170 to 183, wherein the movable cart is the loading cart described in any one of claims 92 to 117.

185. An automated assay system configured to use assay consumables in the performance of the assay, wherein the assay system comprises at least one processor and at least one storage medium. The storage medium stores the instruction for the processor to perform the assay. The instruction is divided into multiple components, and the multiple components are, Security components and User interface components, Instrument control components and, Data service components and, Equipped with, Each component operates substantially independently of the others and has substantially no interaction with one another. The aforementioned components are connected to a master organizer, and the master organizer commands each component to know when to operate. Automated assay system.

186. The assay system according to claim 185, wherein the system comprises a plurality of components, and updating one component does not require revalidation of all of the components.

187. The assay system according to claim 185 or 186, wherein the master organizer functions as a route for passing information between the plurality of components.

188. The assay system according to any one of claims 185 to 187, wherein at least one of the components is further divided into subcomponents, each subcomponent operates substantially independently of and substantially does not interact with one another, a submaster organizer is connected to the subcomponents, and the submaster organizer commands each subcomponent when to operate.

189. The assay system according to claim 188, wherein updating one subcomponent does not require all revalidation of the subcomponent.

190. An assay system configured to use assay consumables in the execution of a first assay, wherein the first assay comprises a unique assay identifier, and the assay system is A reader adapted to read the aforementioned unique assay identifier, A processor that accesses general protocol files and instrument parameter files, Equipped with, The general protocol file includes a general assay protocol that includes a validation step applicable to a plurality of assays, including the first assay. The instrument parameter file includes multiple flags that are either on or off, The processor, in order to perform the first assay, follows the flag and the general Turn the aforementioned assay step in the assay protocol on or off. Assay system.

191. The assay system according to claim 190, wherein the general assay protocol includes a test step for the V-PLEX assay.

192. The assay system according to claim 190, wherein the general assay protocol includes a test step for the U-PLEX assay.

193. The assay system according to claim 190, wherein the general assay protocol includes a test step for an immunogenicity assay.

194. The assay system according to claim 190, wherein the general assay protocol includes a test step for a pharmacokinetic assay.

195. The assay system according to claim 190, wherein the general assay protocol includes a calibration step for a custom sandwich assay.

196. An automated assay system configured to minimize variations in user, instrument, and assay method, Measures to minimize user errors during system loading, Means to minimize user error when selecting automated workflows, Means to minimize sample dilution errors, Measures to minimize errors in handling system plates, Measures to minimize system dispensing errors, Means to minimize temperature fluctuations, Means for minimizing evaporation or condensation in assay consumables, Means for controlling the oscillation frequency of at least one shaker, Means to minimize the complexity of maintenance procedures and A system including at least one of the following.

197. An automated assay system configured to minimize variations in user, instrument, and assay method, wherein the system comprises a robotic gripper arm and a robotic pipette. Perform the sample dilution step, Selecting and executing the correct assay workflow for a given assay, Controlling the air cooling system to maintain a defined temperature within the assay workflow area of ​​the system within defined tolerances, Maintaining consistent timing between runs, plates, and wells, To enable users to perform different assay workflows without having to reconfigure or re-verify the workflow software. An automated assay system also comprising software and instrument components for at least one of the following.

198. The assay system according to claim 196 or 197, comprising the assay system according to any one of claims 1 to 12, 151 to 168, and 185 to 195.

199. The system according to any one of claims 196 to 198, comprising the loading cart according to any one of claims 92 to 117.

200. An assay system according to any one of claims 196 to 199, comprising the apparatus according to any one of claims 146 to 150.

201. The assay system according to any one of claims 196 to 200, comprising the cooling air treatment system shown in any one of Figures 10(l) to 10(p).

202. The assay system according to any one of claims 196 to 201, comprising the assay system shown in any one of Figures 10(a) to 10(d), Figure 10(l), or Figure 10(s).

203. The assay system according to any one of claims 196 to 202, comprising the assay reagent holder according to any one of claims 23 to 57.

204. The assay system according to any one of claims 196 to 203, comprising the kit according to any one of claims 58 to 63.

205. The assay system according to any one of claims 196 to 204, comprising the lid according to any one of claims 64 to 82.

206. The assay system according to any one of claims 196 to 205, comprising the lid according to any one of claims 83 to 91.

207. The assay system according to any one of claims 196 to 206, comprising the computer-readable medium according to claim 21 or 22.

208. An automated assay system comprising a robotic gripper arm and a robotic pipette, comprising at least the following additional components: (a) a plate carrier, (b) a tip box carrier, (c) five optional heatable shakers, (d) an air cooling system, (e) an assay consumable storage unit for assay reagents, (f) an assay consumable storage unit for readily available tips, (g) an assay consumable storage unit for spare tips, (h) an assay consumable storage unit for plates, and (i) an assay consumable storage unit for tubes and troughs. An automated assay system comprising (j) a position for fixing a net, and a platform or table, or both, wherein the components (a) to (c) and (e) to (h) are located in the platform or table in the system at substantially the same positions relative to each other as shown in Figures 10(a), 10(b), 10(c), 10(l), 10(n), or 10(o), and component (d) is located at the back panel of the instrument as substantially shown in Figures 10(l), 10(m), or 10(n).

209. The assay system according to claim 208, further comprising a plate washing machine located below the platform or the table, wherein the platform or the table has an opening for accessing the plate washing machine.

210. The assay system according to claim 208 or 209, comprising both a platform and a table, wherein the platform is mounted on the table and supported by the table.

211. The assay system according to any one of claims 208 to 210, further comprising an assay reading device.

212. The assay system according to claim 211, wherein the assay reading device is located below the platform or the table.

213. The assay system according to any one of claims 208 to 212, wherein the platform or table has an opening for disposing of waste.

214. The assay system according to claim 213, further comprising a chute for solid waste extending from, through, and below the waste opening.

215. The assay system according to any one of claims 208 to 214, further comprising at least one waste container located below the platform or the table.

216. The assay system according to any one of claims 208 to 215, further comprising the robotic gripper, the robotic pipette, and a laptop computer for controlling the components (c) and (d).

217. The assay system according to any one of claims 208 to 216, wherein the components are positioned relative to each other as substantially shown in Figures 10(c), 10(l), and 10(n).

218. The assay system according to any one of claims 208 to 217, further comprising a container for washing buffer and liquid waste below the plate washing machine.

219. The assay system according to any one of claims 208 to 218, further comprising a wiring diagram of one or a combination of Figures 10(v) to 10(y).

220. The assay system according to any one of claims 208 to 219, wherein the components are positioned relative to each other as shown in one or a combination of Figures 10(a) to 10(d), Figures 10(l) to 10(p), Figure 10(s), and Figure 10(u).

221. The assay system according to any one of claims 208 to 220, wherein the aforementioned components have dimensions within 10% of the dimensions shown in any of the figures.

222. The assay system according to any one of claims 208 to 221, further comprising a universal power supply (UPS) below the platform or the deck.

223. The assay system according to any one of claims 208 to 222, wherein the components below the platform or deck are divided into compartments as shown in Figure 10(a), Figure 10(b), or Figure 10(c).

224. An automated method for performing an assay comprising any of the following sequences and timings: Figure 9d, Figures 12(m) to 12(p), Figures 12(r) to 12(s), Figures 13(d) to 13(f), Figure 14(d), Figures 14(f) to 14(l), Figure 15(b), Figures 15(d) to 15(h), Figure 16(b), Figure 17(b), Figures 17(d) to 17(h).

225. An automated assay system, (a) A single robot-controlled 8-channel pipette, (b) A single robot-controlled assay plate gripper arm, (c) A single 96-channel assay plate washer, (d) A single plate reader and (e) One or more plate shakers having a total capacity of at least five plate shaking locations, (f) A processor adapted to perform an assay process for analyzing multiple samples in a 96-well plate, wherein the process performs the following operations: (i) A blocking step including adding a block buffer having the pipette, incubation during the blocking period (b), and washing using the plate washer, (ii) A sample binding step including shaking in one of the plate shaking locations and washing using the plate washing machine, while adding one of the samples using the pipette and incubation during the sample incubation period (s), (iii) A detector coupling step including shaking the plate in one of the plate shaking locations, washing the plate using the plate washing machine, adding a detection reagent using the pipette, and incubation during the detector incubation period (d), (iv) Addition of reading buffer using the pipette, (v) Measurement of the assay signal using the reading device, A processor and are executed in each well of the plate. Equipped with, Up to five plates can be processed in a single run. An automated assay system in which the steps described above are performed as shown in Figures 9(d), 12(m) to 12(p), 12(r) to 12(s), 13(d) to 13(f), 14(d), 14(f) to (l), 15(b), 15(d) to 15(h), 16(b), 17(b), 17(d) to 17(h).

226. The aforementioned process is as follows: (vi) Diluting the calibrator storage solution using the pipette to form a plurality of calibration standards, wherein the standards include the plurality of samples; (vii) Using the pipette, one or more of the samples are pre-diluted before adding them to the wells of the plate; (viiii) The step of using the pipette to combine a plurality of detection reagent components to form the detection reagent, The system according to claim 225, further comprising one or more of the above.

227. The system according to claim 225 or 226, wherein the steps are performed under temperature control that can maintain a temperature of 20 to 24°C ± 1°C.

228. The system according to any one of claims 225 to 227, wherein the measurement is an ECL measurement.

229. The system according to any one of claims 225 to 228, wherein the measurement is a multiple measurement.

230. An automated assay system, (a) A processing deck for holding assay components having a front edge, a first side edge, a second side edge, and a rear edge on a substantially rectangular surface, (i) A cantilevered assay consumable hotel positioned approximately in the center of the front end of the deck, having a plurality of consumable slots sized to hold consumables that meet the ANSI-SLAS specifications in terms of width and length of the 96-well assay plate, (ii) Multiple pipette tip locations for holding pipette tip containers located on the first side of the deck, (iii) A plurality of plate shaker locations located along the rear edge of the deck, (iv) The set of the processing area located approximately in the center of the deck between the hotel and the shaker configured to hold consumables having dimensions in accordance with ANSI-SLAS To and, (v) A barcode scanner located on the first side of the deck behind the pipette tip location, the barcode scanner having a scanning surface large enough to scan the bottom surface of a consumable having dimensions compliant with ANSI-SLAS; The deck having, (b) A plate washer located below the deck and accessible through an opening in the deck between the pipetting area and the assay plate processing area, (c) A gantry located above the deck that movably supports a robotic plate gripper so that the gripper can move to access location (i) to (v), and movably supports a robotic 8-channel pipette so that the pipette can access locations (ii) and (iv), (d) an assay reading device located next to the first side of the deck on a platform which is a vertical height lower than the deck, wherein the highest point on the reading device is lower than the lowest point to which the robot grabber can move, (e) An enclosure surrounding components (a) to (d), having a temperature controller for maintaining the components under temperature control and a door that provides a user with access to the front of the deck and the consumable hotel located above it, An automated assay system equipped with the following features.

231. The system according to claim 238, further comprising the apparatus according to any one of claims 146 to 150.

232. An automated assay system, (a) A single robot-controlled 8-channel pipette, (b) A single robot-controlled assay plate gripper arm, (c) A single 96-channel assay plate washer, (d) A single plate reader and (d) One or more plate shakers having a total capacity of at least five plate shaking locations, (e) A processor adapted to perform an assay process for analyzing multiple samples in a 96-well plate, wherein the following operations are performed: (i) a blocking step including adding block buffer using the pipette, incubation during the blocking period (b), and (c) washing using the plate washer, (ii) A sample binding step including adding one of the samples using the pipette, shaking in one of the plate shaking locations and washing with the plate washing machine, and incubation during a sample incubation period (s), (iii) A detector coupling step including shaking in one of the plate shaking locations, washing with the plate washing machine, adding the detection reagent using the pipette, and incubation during the detector incubation period (d), (iv) Addition of a reading buffer having the pipette, (v) Measurement of assay signal using the reading device and The processor that runs in each well of the plate Equipped with, Up to five plates can be processed in a single run. Automated assay system.

233. The system according to claim 240, further comprising the apparatus according to any one of claims 146 to 150.

244. The aforementioned region accepts at least one tube and at least one vial. A holder according to any one of claims 23 to 51, configured as follows.

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