Modular assay plates, reader systems and methods for test measurements

• US 7,981,362 B2
• Filed: 11/03/2004
• Issued: 07/19/2011
• Est. Priority Date: 11/04/2003
• Status: Active Grant

• Current Assignee: Meso Scale Technologies, LLC
• Original Assignee: Meso Scale Technologies, LLC
• Inventors: Kishbaugh, Alan, Jeffrey-Coker, Bandele, Glezer, Eli, Clinton, Charles, Johnson, Kent
• Primary Examiner(s): Griffin; Walter D
• Assistant Examiner(s): Mui; Christine T
• Application Number:
  US10/980,198
• Publication Number:
  US 20050142033A1
• Time in Patent Office: 2,449 Days
• Field of Search: 422/102, 356/311, 356/246
• US Class Current: 422/50
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0829 Multi-well plates; Microtitration plates
• CPC Class Codes: B01L 2300/0851 Bottom walls
• CPC Class Codes: B01L 3/5085 for multiple samples, e.g. microtitration plates
• CPC Class Codes: B01L 3/50855 using modular assemblies of strips or of individual wells
• CPC Class Codes: G01N 21/253 for batch operation, i.e. multisample apparatus analytical automats G01N35/00
• CPC Class Codes: G01N 21/66 electrically excited, e.g. electroluminescence
• CPC Class Codes: G01N 21/76 Chemiluminescence; Bioluminescence
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 35/028 having reaction cells in the form of microtitration plates

Abstract

Luminescence test measurements are conducted using an assay module having integrated electrodes with a reader apparatus adapted to receive assay modules, induce luminescence, preferably electrode induced luminescence, in the wells or assay regions of the assay modules and measure the induced luminescence.

Claims

1. An assay module having an array of wells with integrated electrodes, said module comprising

(a) a module lip and a snap fit element extending from said module, said snap fit element positioned below said lip, wherein said lip and said snap fit element are configured to engage a plate frame of a multi-well plate;

(b) a module top having a plurality of through-holes that define the walls of said array of wells; and

(c) a module bottom defining the bottom of said array of wells.

2. The assay module of claim 1, wherein said module bottom further comprises:

an insulating substrate with a first surface having a first conductive layer patterned thereon, a second opposing surface having a second conductive layer patterned thereon and conductive through-holes connecting regions of said first conductive layer with regions of said second conductive layer;

wherein, said module bottom is mated to said module top with a fluid tight seal so that said first surface defines the bottom of said wells, said first conductive layer provides each well with at least one working electrode surface and one counter electrode surface, and said second conductive layer provides points of electrical contact to said working and counter electrodes.

3. The assay module of claim 2, wherein said first and/or second conductive layers comprise elemental carbon.

4. The assay module of claim 1, wherein said array of wells comprises a first well comprising a first binding reagent for a first analyte of interest.

5. The assay module of claim 4, wherein said array of wells comprises a second well comprising a second binding reagent for a second analyte of interest.

6. The assay module of claim 5, further comprising a third well comprising a negative control reagent and/or a fourth well comprising a positive control reagent.

7. The assay module of claim 5, wherein said first and second binding reagents are immobilized on working electrode surfaces within said first and second wells, respectively.

8. The assay module of claim 1, wherein said array of wells is a linear array of wells.

9. The assay module of claim 1, wherein said array of wells is a square array of wells.

10. A multi-well plate comprising:

(a) two or more of the assay modules of claim 1; and

(b) a plate frame defining two or more apertures for receiving and holding said two or more assay modules, said plate frame having a frame lip that extends into said apertures and is engaged in a snap fit configuration by said module lip and said snap fit element.

11. The multi-well plate of claim 10, wherein said plate comprises a plurality of said modules and at least two of said modules are configured to carry out the same panel of assays.

12. The multi-well plate of claim 10, wherein said plate comprises a plurality of said modules and at least two of said modules are configured to carry out different panels of assays.

13. A kit for assembling a multi-well plate comprising:

(a) two or more of the assay modules of claim 1; and

(b) a plate frame defining two or more apertures for receiving and holding said two or more assay modules, said plate frame having a frame lip that extends into said apertures, wherein said plate frame can receive said assay modules by engaging said frame lip in a snap fit configuration with said module lip and said snap fit element.

14. The kit of claim 13, wherein said kit comprises a plurality of said modules and at least two of said modules are configured to carry out the same panel of assays.

15. The kit of claim 13, wherein said kit comprises a plurality of said modules and at least two of said modules are configured to carry out different panels of assays.

16. A kit for assembling a multi-well plate comprising a plurality of the assay modules of claim 1.

17. The kit of claim 16, wherein at least two of said modules are configured to carry out the same panel of assays.

18. The kit of claim 16, wherein at least two of said modules are configured to carry out different panels of assays.

19. A multi-well plate comprising:

(a) two or more multi-well assay modules of claim 1, each having a multi-well array of wells with integrated electrodes; and

(b) a plate frame defining two or more apertures for receiving and holding said two or more multi-well assay modules, said modules being held within said plate frame, and said plate frame is adapted to receive said multi-well assay modules through a snap fit feature.

20. The multi-well plate of claim 19, wherein said assay modules are held within said plate frame through a snap fit configuration.

21. The multi-well plate of claim 19, wherein each of said module bottoms further comprises:

an insulating substrate with a first surface having a first conductive layer patterned thereon, a second opposing surface having a second conductive layer patterned thereon and conductive through-holes connecting regions of said first conductive layer with regions of said second conductive layer;

wherein, said module bottom is mated to said module top with a fluid tight seal so that said first surface defines the bottom of said wells, said first conductive layer provides each well with at least one working electrode surface and one counter electrode surface, and said second conductive layer provides points of electrical contact to said working and counter electrodes.

22. The multi-well plate of claim 21, wherein said first and/or second conductive layers comprise elemental carbon.

23. The multi-well plate of claim 19, wherein said plate comprises a plurality of said modules and at least two of said modules are configured to carry out the same panel of assays.

24. The multi-well plate of claim 19, wherein said plate comprises a plurality of said modules and at least two of said modules are configured to carry out different panels of assays.

25. The multi-well plate of claim 19, wherein said modules comprise at least one well containing a binding reagent for an analyte of interest.

26. The multi-well plate of claim 25, wherein said binding reagent is immobilized on a working electrode within said well.

27. A kit for assembling a multi-well plate comprising:

(a) two or more multi-well assay modules of claim 1, each having a multi-well array of wells with integrated electrodes; and

(b) a plate frame defining two or more apertures for receiving and holding said multi-well assay modules, wherein said plate frame is adapted to receive said assay modules through a snap fit feature.

28. The kit of claim 27, wherein each of said module bottoms further comprises:

an insulating substrate with a first surface having a first conductive layer patterned thereon, a second opposing surface having a second conductive layer patterned thereon and conductive through-holes connecting regions of said first conductive layer with regions of said second conductive layer;

wherein, said module bottom is mated to said module top with a fluid tight seal so that said first surface defines the bottom of said wells, said first conductive layer provides each well with at least one working electrode surface and one counter electrode surface, and said second conductive layer provides points of electrical contact to said working and counter electrodes.

29. The kit of claim 28, wherein said first and/or second conductive layers comprise elemental carbon.

30. The kit of claim 27, wherein said kit comprises a plurality of said modules and at least two of said modules are configured to carry out the same panel of assays.

31. The kit of claim 27, wherein said kit comprises a plurality of said modules and at least two of said modules are configured to carry out different panels of assays.

32. The kit of claim 27, wherein said modules comprise at least one well containing a binding reagent for an analyte of interest.

33. The kit of claim 32, wherein said binding reagent is immobilized on a working electrode within said well.

43. A method for carrying out an electrode induced luminescence assay comprising:

(a) introducing one or more samples into one or more wells of a multi-well plate according to claim 10; and

(b) applying an electrical potential to said electrodes and measuring luminescence produced in said wells.

44. A method for carrying out an electrode induced luminescence assay comprising:

(a) introducing one or more samples into one or more wells of one or more assay modules according to claim 1;

(b) inserting said assay modules into a plate frame that defines one or more apertures for receiving and holding said multi-well assay modules; and

(c) applying an electrical potential to said electrodes and measuring luminescence produced in said wells.

45. The method of claim 43, wherein said one or more samples are introduced into a plurality of said assay modules and said step of applying electrical potential and measuring luminescence is conducted sequentially on each of said assay modules.

34. A method for carrying out an electrode induced luminescence assay comprising:

(a) introducing one or more samples into one or more wells of a multi-well plate comprising;

(i) one or more multi-well assay modules, said modules comprising a module lip and a snap fit element extending from said module, said snap fit element positioned below said lip, wherein said lip and said snap fit element are configured to engage a plate frame of a multi-well plate, said modules each having an array of wells with integrated electrodes; and

(ii) a plate frame defining one or more apertures for receiving and holding said multi-well assay modules; and

(b) applying an electrical potential to said electrodes and measuring luminescence produced in said wells.

35. The method of claim 34, further comprising inserting said one or more modules in said plate frame.

37. The method of claim 34, wherein said one or more samples are introduced into a plurality of said assay modules and said step of applying electrical potential and measuring luminescence is conducted sequentially on each of said assay modules.

38. The method of claim 34, wherein at least one of said wells comprises a binding reagent for an analyte of interest.

39. The method of claim 38, wherein said binding reagent is labeled with an electrochemiluminescent label.

40. The method of claim 38, wherein said binding reagent is immobilized on working electrodes within said wells.

41. The method of claim 34, wherein one sample is distributed into wells on a plurality of said assay modules and at least two of said plurality of assay modules being configured for carrying out different panels of assays.

42. The method of claim 34, wherein a plurality of samples are distributed into a plurality of said assay modules, including at least a first sample that is distributed into wells of a first of said assay modules and a second sample that is distributed into wells of a second of said assay modules, said first and second assay modules being configured for carrying out the same panel of assays.

36. A method for carrying out an electrode induced luminescence assay comprising:

(a) introducing one or more samples into one or more wells of one or more assay modules, said modules comprising a module lip and a snap fit element extending from said module, said snap fit element positioned below said lip, wherein said lip and said snap fit element are configured to engage a plate frame of a multi-well plate, said modules having arrays of wells with integrated electrodes;

(b) inserting said assay modules into a plate frame that defines one or more apertures for receiving and holding said multi-well assay modules; and

(c) applying an electrical potential to said electrodes and measuring luminescence produced in said wells.