AUTOMATED ANALYZER FOR CLINICAL LABORATORY

• US 20090117620A1
• Filed: 10/24/2008
• Published: 05/07/2009
• Est. Priority Date: 11/05/2007
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Gardner, Gregory E., Fritchie, Patrick P., Mahoney, Richard W.
• Granted Patent: US 8,222,048 B2
• Time in Patent Office: Days
• US Class Current: 435/91.100
• CPC Class Codes: B01L 2300/0829 Multi-well plates; Microtitration plates
• CPC Class Codes: B01L 3/5085 for multiple samples, e.g. microtitration plates
• CPC Class Codes: G01N 2035/00564 Handling or washing solid phase elements, e.g. beads
• CPC Class Codes: G01N 2035/0406 Individual bottles or tubes
• CPC Class Codes: G01N 2035/1051 for transporting containers, e.g. retained by friction
• CPC Class Codes: G01N 35/0098 involving analyte bound to insoluble magnetic carrier, e.g. using magnetic separation magnetic particles used in immunoassays G01N33/54326; magnetic separation in general B03C
• CPC Class Codes: G01N 35/0099 comprising robots or similar manipulators robots per se B25J
• CPC Class Codes: G01N 35/028 having reaction cells in the form of microtitration plates
• CPC Class Codes: G01N 35/1002 Reagent dispensers
• CPC Class Codes: G01N 35/1065 Multiple transfer devices
• CPC Class Codes: Y02P 20/582 Recycling of unreacted starting or intermediate materials
• CPC Class Codes: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/113332 with conveyance of sample along a test line in a container or rack
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A laboratory automation system that is capable of carrying out clinical chemistry assays, immunoassays, amplification of nucleic acid assays, and any combination of the foregoing, said laboratory automation system employing at least one of micro-well plates and deep multi-well plates as reaction vessels. The use of micro-well plates as reaction vessels enables the laboratory automation system to assume a variety of arrangements, i.e., the laboratory automation system can comprise a variety of functional modules that can be arranged in various ways. In order to effectively carry out immunoassays by means of micro-well plates, a technique known as inverse magnetic particle processing can be used to transfer the product(s) of immunoassays from one micro-well of a micro-well plate to another.

Claims

1. A laboratory automation system that is capable of carrying out clinical chemistry assays, immunoassays, or both clinical chemistry assays and immunoassays, said laboratory automation system employing micro-well plates as reaction vessels.

2. The laboratory automation system of claim 1, wherein the laboratory automation system comprises a plurality of functional modules.

3. The laboratory automation system of claim 2, wherein the laboratory automation system comprises an immunoassay module, wherein said immunoassay module comprises a magnetic particle processor.

4. The laboratory automation system of claim 3, wherein as many as twenty-four (24) immunoassays can be carried out in the magnetic particle processor simultaneously.

5. The laboratory automation system of claim 3, wherein as many as 96 immunoassays can be carried out in the magnetic particle processor simultaneously.

6. The laboratory automation system of claim 1, wherein the same aspirating/dispensing device can be used for aspirating and dispensing liquids for both immunoassays and clinical chemistry assays.

7. The apparatus of claim 1, wherein said laboratory automation system has troughs for holding bulk reagents.

8. A laboratory automation system that is capable of carrying out extraction of a nucleic acid from a biological sample and amplification of the nucleic acid thus extracted, said laboratory automation system employing multi-well plates for preparing the biological sample for a thermal cycler.

9. The laboratory automation system of claim 8, wherein the laboratory automation system comprises a plurality of functional modules.

10. The laboratory automation system of claim 9, wherein the laboratory automation system comprises a module for extraction of nucleic acid from a biological sample, wherein said extraction module comprises a magnetic particle processor.

11. A method carrying out immunoassays and clinical chemistry assays in a laboratory automation system, wherein said method includes a plurality of automated protocols, said protocols including addition of samples to micro-wells in a micro-well plate, addition of reagents to micro-wells in a micro-well plate, mixing of the contents of micro-wells in a micro-well plate, incubation of reactants in micro-wells in a micro-well plate, and washing reaction products of micro-wells in a micro-well plate.

12. The method of claim 11, further including separating reaction products of micro-wells in a micro-well plate.

13. The method of claim 11, wherein the method includes aspirating/dispensing protocols for kitting micro-well plates by means of a schedule not constrained by a fixed protocol.

14. The method of claim 11, wherein kitting of the micro-wells of a micro-well plate can be carried out prior to the entry of a micro-well plate into a magnetic particle processing apparatus.

15. The method of claim 11, wherein the aspirating/dispensing protocols enable devices for aspirating/dispensing to be used for dispensing samples and reagents for clinical chemistry assays while immunoassays are being carried out.

16. The method of claim 11, wherein immunoassays and clinical chemistry assays can be scheduled in such a manner that clinical chemistry assays can be carried out between immunoassays and immunoassays can be carried out between clinical chemistry assays.

17. The method of claim 11, wherein sample containers, reagent containers, and micro-well plates are lifted, transported, and lowered by the aspirating/dispensing device.

18. The method of claim 17, wherein pipettes of the aspirating/dispensing device are equipped with gripping devices that can grip and transfer sample containers, reagent containers, and micro-well plates from one position to another.

19. The method of claim 11, wherein radio frequency identification tags are positioned at least one of reagent containers, sample containers, sample container carriers, and micro-well plates.

20. The method of claim 19, wherein the radio frequency identification tags enable tracking of micro-well plates from the initial dispensing of samples and reagents to the final reading of results from the micro-well plates.

21. The method of claim 11, wherein the magnetic particle processor is used to carry out a homogeneous immunoassay.

22. The method of claim 11, wherein reagent containers and sample containers can be transferred from a refrigerated storage area to the analysis section of the laboratory automation system by an automated robotic mechanism.

23. The method of claim 11, wherein consumable items are ordered by means of a computer interface connecting the laboratory automation system with a vendor.

24. The method of claim 11, wherein the laboratory automation system comprises a graphical user interface for enabling an operator to closely control and monitor immunoassays or clinical chemistry assays or both immunoassays and clinical chemistry assays, said graphical user interface utilizing fuel gauge-type liquid level indicators to simplify reading of liquid levels in containers.

25. The method of claim 11, wherein the laboratory automation system comprises a graphical user interface for enabling an operator to closely control and monitor immunoassays or clinical chemistry assays or both immunoassays and clinical chemistry assays, said graphical user interface utilizing instructional balloons to instruct relatively inexperienced operators in proper usage of the laboratory automation system.

26. A method carrying out extraction of nucleic acid from a biological sample and amplification of the nucleic acid thus extracted in a laboratory automation system, wherein said method includes a plurality of automated protocols, said protocols including addition of the biological sample to wells in a multi-well plate, addition of reagent to a well in a multi-well plate, mixing of the contents of the well in a multi-well plate, incubation of the contents of the well in a multi-well plate, and washing the contents of the well in a multi-well plate.

27. The method of claim 26, wherein said reagents include lysis buffer.

28. The method of claim 26, wherein the method includes aspirating/dispensing protocols for kitting multi-well plates by means of a schedule not constrained by a fixed protocol.

29. The method of claim 26, wherein kitting of the wells of a multi-well plate can be carried out prior to the entry of a multi-well plate into a magnetic particle processing apparatus.

30. The method of claim 26, wherein the aspirating/dispensing protocols enable devices for aspirating/dispensing to be used for dispensing biological samples and reagents for extraction of nucleic acids while clinical chemistry assays or immunoassays or both clinical chemistry assays and immunoassays are being carried out.

31. The method of claim 30, wherein immunoassays and clinical chemistry assays can be scheduled in such a manner that clinical chemistry assays can be carried out between immunoassays and immunoassays can be carried out between clinical chemistry assays.

32. The method of claim 26, wherein sample containers, reagent containers, and multi-well plates are lifted, transported, and lowered by the aspirating/dispensing device.

33. The method of claim 32, wherein pipettes of the aspirating/dispensing device are equipped with gripping devices that can grip and transfer sample containers, reagent containers, and multi-well plates from one position to another.

34. The method of claim 26, wherein radio frequency identification tags are positioned at least one of reagent containers, sample containers, sample container carriers, and multi-well plates.

35. The method of claim 34, wherein the radio frequency identification tags enable tracking of multi-well plates from the initial dispensing of samples and reagents to the final reading of results from the multi-well plates.

36. The method of claim 26, wherein reagent containers and sample containers can be transferred from a refrigerated storage area to the analysis section of the laboratory automation system by an automated robotic mechanism.

37. The method of claim 26, wherein consumable items are ordered by means of a computer interface connecting the laboratory automation system with a vendor.

38. The method of claim 26, wherein the laboratory automation system comprises a graphical user interface for enabling an operator to closely control and monitor immunoassays or clinical chemistry assays or both immunoassays and clinical chemistry assays, said graphical user interface utilizing fuel gauge-type liquid level indicators to simplify reading of liquid levels in containers.

39. The method of claim 26, wherein the laboratory automation system comprises a graphical user interface for enabling an operator to closely control and monitor immunoassays or clinical chemistry assays or both immunoassays and clinical chemistry assays, said graphical user interface utilizing instructional balloons to instruct relatively inexperienced operators in proper usage of the laboratory automation system.

40. A laboratory automation system that is capable of carrying out clinical chemistry assays, immunoassays, amplification of nucleic acid assays, and any combination of the foregoing, said laboratory automation system employing at least one of micro-well plates and deep multi-well plates as reaction vessels, said laboratory automation system comprising modules that are capable of being added to, subtracted from, or rearranged.

41. A laboratory automation system that is capable of carrying out clinical chemistry assays, immunoassays, amplification of nucleic acid assays, and any combination of the foregoing, said laboratory automation system employing at least one of micro-well plates and deep multi-well plates as reaction vessels, said laboratory automation system comprising a system for controlling evaporation of reagents by means of a plurality of sliding covers.