Integrated consumable data management system and platform

Patent metadata

Field	Value
Publication number	US-12360130-B2
Application number	US-202318354382-A
Country	US
Kind code	B2
Filing date	Jul 18, 2023
Priority date	Jul 23, 2015
Publication date	Jul 15, 2025
Grant date	Jul 15, 2025

Abstract

The present invention relates to methods, devices and systems for associating consumable data with an assay consumable used in a biological assay. Provided are assay systems and associated consumables, wherein the assay system adjusts one or more steps of an assay protocol based on consumable data specific for that consumable. Various types of consumable data are described, as well as methods of using such data in the conduct of an assay by an assay system. The present invention also relates to consumables (e.g., kits and reagent containers), software, data deployable bundles, computer-readable media, loading carts, instruments, systems, and methods, for performing automated biological assays.

First claim

The invention claimed is:

1. A method for training a robotic controlled probe of an assay system comprising the steps of:
positioning a training plate sized and dimensioned to the size and dimensions of an assay plate in a plate carrier inside the assay system, wherein the position of said training plate is known in a three-dimensional coordinate system,
moving the robotic controlled probe toward a reference pad on said training plate, wherein said reference pad corresponds to a well in said assay plate,
obtaining a first location of said reference pad using a capacitance between the robotic controlled probe and said reference pad in said three-dimensional coordinate system, and
assigning said first location as one dimension in said three-dimensional coordinate system for the robotic controlled probe.

2. The method of claim 1 , wherein the robotic controlled probe is part of a pipetting subsystem that comprises a pump, and a valve.

3. The method of claim 1 , wherein the robotic controlled probe comprises a multi-channel pipetting probe having a plurality of pipette tips for enabling fluid transfer to a plurality of wells of the assay plate either through all of the plurality of pipette tips or through a selected number of pipette tips less than all of the available pipette tips.

4. The method of claim 1 , wherein the training plate is reversible such that a bottom surface of the training plate has the same features as a top surface of the training plate.

5. An assay consumable storage unit adapted to be attached to a platform in an assay system, the assay consumable storage unit comprising a bottom base and a shelving assembly having a plurality of sets of vertically aligned storage units, wherein each storage unit is sized and dimensioned to receive a consumable for conduct of an assay by the assay system,
wherein the shelving assembly comprises a plurality of horizontal members connected by a plurality of upstanding vertical supports,
wherein the bottom base is configured to be affixed in a cantilevered manner to the platform and the shelving assembly is removably attached to the bottom base by at least two locating pins and by at least one threaded connector with a finger-actuatable head.

6. The assay consumable storage unit of claim 5 , wherein the shelving assembly comprises an M×N rectilinear array of sets of vertically aligned storage units, wherein M and N are integers.

7. The assay consumable storage unit of claim 5 , wherein a top horizontal member comprises alignment features for an ANSI-SLAS compliant container bottom.

8. The assay consumable storage unit of claim 5 , wherein a top horizontal member comprises alignment features for a lid of an assay reagent holder that is larger than an ANSI-SLAS compliant container bottom.

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

10. The assay system of claim 9 , wherein the array of pressure transducers is configured to not be responsive to a human audible frequency range.

11. The assay system of claim 10 , wherein the array of pressure transducers is configured to not be responsive to a frequency range between about 2048 Hz to about 8192 Hz.

12. A method for operating an automated assay system to minimize potential errors in loading consumables for an assay and running the assay,
wherein said assay system comprises a robotic controlled pipettor and a robotic 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,
wherein the assay system is adapted to receive consumables the 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 calibrator, control, diluents, antibodies, reagents and buffers,
said method comprises at least one of the following steps:
guiding a user via a user interface to load the consumables into the assay system,
instructing the robotic controlled gripper arm to place a lid on the at least one assay test plate,
instructing the at least one heat exchanger to maintain a selected temperature within the assay system, and
instructing the at least one processor to run the assay for the at least one assay test plate, wherein the assay for each assay test plate is completed in substantially a same time period.

13. The method of claim 12 , wherein the assay reader is an electrochemiluminescence reader.

14. The method of claim 12 , wherein the step of instructing the user interface includes at least one instruction to load the consumables from a kit, or to load the consumables to an intermediate consumable loading station.

15. The method of claim 14 , wherein the intermediate consumable loading station comprises a mobile cart.

16. The method of claim 12 , further comprising the step of instructing the robotic controlled pipettor to obtain its vertical position using a training plate.

17. The method of claim 12 , further comprising the step of instructing the robotic controlled pipettor to obtain its horizontal position.

18. The method of claim 12 , wherein the step of instructing the robotic controlled gripper arm further includes at least one instruction to obtain a vertical position of the robotic controlled gripper arm using a training plate.

19. The method of claim 18 , wherein the step of instructing the robotic controlled gripper arm further includes at least one instruction to obtain at least one position of the robotic controlled gripper arm on a horizontal plane.

20. The method of claim 12 , wherein the method further includes the step of instructing the at least one processor to execute a qualification procedure.

21. The method of claim 20 , wherein the step of executing the qualification procedure further comprises at least one of the following steps:
(i) validate an electrochemiluminescence reader;
(ii) validate an aspiration function of the plate washer;
(iii) validate a dispensing function of the plate washer; and
(iv) validate a dispensing function of the robotic controlled pipettor.

22. The method of claim 21 , wherein the step to validate the electrochemiluminescence reader further comprises at least one of the following steps:
(a) reading an electronic plate with the electrochemiluminescence reader to validate electrical current flows within the electrochemiluminescence reader;
(b) reading an empty assay test plate with the electrochemiluminescence reader to ascertain background electrical noise; and
(c) reading an assay test plate wherein wells within said assay test plate is filled with a free tag buffer to validate that the electrochemiluminescence reader reads an expected count.

23. The method of claim 12 , wherein the at least one assay test plate comprises multiple assay test plates.

24. An automated assay system comprising a robotic gripper arm and a robotic pipettor, and comprising at least the following additional components: (a) a plate carrier, (b) a tip box carrier, (c) five optionally heatable shakers, (d) an air cooling and handling system, (e) an assay consumable storage unit for assay reagen

Assignees

• Meso Scale Technologies Llc

Inventors

• Wohlstadter Jacob N
• Kochar Manish
• Bosco Peter J
• Jeffrey-Coker Bandele
• Jones Eric M
• Krivoy Gary I
• Leimkuehler Aaron H
• Nguyen Kim-Xuan
• Oberoi Pankaj
• Pang Louis W
• Parker Jennifer
• Pellicier Victor
• Sammons Nicholas
• Sigal George
• Vock Michael L
• Smith Stanley T
• Stevens Carl C
• Osborne Rodger D
• Page Kenneth E
• Wade michael t
• Cong Xinri
• Ng Kin

Classifications

• C40B60/12

  for screening libraries · CPC title

• G01N27/26

  by investigating electrochemical variables; by using electrolysis or electrophoresis · CPC title

• G01N21/76

  Chemiluminescence; Bioluminescence · CPC title

• G01N33/53

  Immunoassay; Biospecific binding assay; Materials therefor · CPC title

• G01N35/0092

  Scheduling · CPC title