Multi-array, multi-specific electrochemiluminescence testing

• US 7,824,925 B2
• Filed: 10/31/2005
• Issued: 11/02/2010
• Est. Priority Date: 03/10/1995
• Status: Expired due to Fees

• Current Assignee: Meso Scale Technologies, LLC
• Original Assignee: Meso Scale Technologies, LLC
• Inventors: Wohlstadter, Jacob N., Martin, Mark, Billadeau, Mark A., Helms, Larry R., Wilbur, James, Fischer, Alan, Sigal, George, Guo, Liang-Hong, Leland, Jon, Darvari, Ramin
• Primary Examiner(s): Chin; Christopher L
• Application Number:
  US11/264,535
• Publication Number:
  US 20060068499A1
• Time in Patent Office: 1,828 Days
• Field of Search: None
• US Class Current: 436/524
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B82Y 15/00 Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors
• CPC Class Codes: B82Y 30/00 Nanotechnology for materials or surface science, e.g. nanocomposites
• CPC Class Codes: C12Q 1/6825 Nucleic acid detection involving sensors
• 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 33/54313 the carrier being characterised by its particulate form
• CPC Class Codes: G01N 33/5438 Electrodes
• CPC Class Codes: G01N 33/582 with fluorescent label
• CPC Class Codes: G01N 33/585 with a particulate label, e.g. coloured latex
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus
• CPC Class Codes: Y10S 435/817 Enzyme or microbe electrode
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/806 Electrical property or magnetic property
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures

Abstract

Materials and methods are provided for producing patterned multi-array, multi-specific surfaces for use in diagnostics. The invention provides for electrochemiluminescence methods for detecting or measuring an analyte of interest. It also provides for novel electrodes for ECL assays. Materials and methods are provided for the chemical and/or physical control of conducting domains and reagent deposition for use multiply specific testing procedures.

Claims

1. A method for detecting or measuring an analyte of interest in a sample in an electrochemiluminescence binding assay comprising:

(a) adding a liquid sample containing an analyte of interest to an assay cassette that comprises

(i) a porous assay electrode;

(ii) a binding reagent specific for said analyte of interest;

(iii) an assay component linked to an electrochemiluminescent label; and

(iv) an electrochemiluminescence coreactant wherein at least one of assay components (ii), (iii) or (iv) are provided in a dry reagent composition;

(b) reconstituting said dry agent composition in said liquid sample;

(c) contacting said electrode with said reconstituted dry reagent composition and said assay components (ii), (iii) or (iv) not provided in said dry reagent composition;

(d) applying a voltage waveform effective to trigger electrochemiluminescence at said electrode; and

(e) detecting or measuring electrochemiluminescence;

wherein said detected or measured electrochemiluminescence correlates to the presence or amount of said analyte in said sample.

2. The method of claim 1, wherein said dry reagent composition comprises said labeled binding reagent.

3. The method of claim 2, wherein said reconstituted dry reagent composition is not washed from said electrode prior to step (d).

4. The method of claim 2, wherein said electrode and dry reagent composition are present in the same reaction enclosure such that steps (b) and (c) occur concurrently.

5. The method of claim 2, wherein said cassette is a multi-well plate.

6. The method of claim 2, wherein said electrode is a carbon composite electrode and said label is an organometallic ruthenium complex.

7. The method of claim 1, wherein said electrode has a binding reagent immobilized thereon.

8. The method of claim 1, wherein said dry reagent composition contains at least one additional component selected from the group consisting of blocking agents, sugars, polysaccharides, surfactants, preservatives or buffering salts.

9. The method of claim 1, wherein said dry reagent composition comprises said electrochemiluminescence coreactant.

10. The method of claim 7, wherein said reconstituted dry reagent composition is not washed from said electrode prior to step (d).

11. The method of claim 7, wherein said electrode and dry reagent composition are present in the same reaction enclosure such that steps (b) and (c) occur concurrently.

12. The method of claim 7, wherein said cassette is a multi-well plate.

13. The method of claim 7, wherein said electrochemiluminescence coreactant is a tertiary amine.

14. The method of claim 13, wherein said amine is tripropylamine.

15. The method of claim 1, wherein said electrode is a carbon composite electrode and said electrochemiluminescent label is an organometallic ruthenium complex.

16. The method of claim 7, wherein said dry reagent composition contains at least one additional component selected from the group consisting of blocking agents, sugars, polysaccharides, surfactants, preservatives or buffering salts.

17. The method of claim 1, wherein said dry reagent composition comprises said labeled binding reagent and said electrochemiluminescence coreactant.

18. The method of claim 17, wherein said reconstituted dry reagent composition is not washed from said electrode prior to step (d).

19. The method of claim 17, wherein said electrochemiluminescence coreactant is a tertiary amine.

20. The method of claim 19, wherein said amine is tripropylamine.

21. The method of claim 17, wherein said label is an organometallic ruthenium complex and said electrode is a carbon composite electrode.

22. The method of claim 17, wherein said electrode and dry reagent composition are present in the same reaction enclosure such that steps (b) and (c) occur concurrently.

23. The method of claim 17, wherein said cassette is a multi-well plate.

24. The method of claim 17, wherein said electrode has a binding reagent immobilized thereon.

25. The method of claim 17, wherein said dry reagent composition contains at least one additional component selected from the group consisting of blocking agents, sugars, polysaccharides, surfactants, preservatives or buffering salts.

26. A cassette for detecting or measuring an analyte of interest in a sample in an electrochemiluminescence binding assay comprising:

(a) a porous assay electrode;

(b) a binding reagent specific for said analyte of interest;

(c) an assay component linked to an electrochemiluminescent label; and

(d) an electrochemiluminescence coreactant,

wherein at least one of assay components (b), (c) or (d) are provided in a dry reagent composition.

27. The cassette of claim 26, wherein said dry reagent comprises said labeled binding reagent and said electrochemiluminescence coreactant.

28. The cassette of claim 27, wherein said label is an organometallic ruthenium complex and said coreactant is a tertiary amine.

29. The cassette of claim 28, wherein said electrode has a binding reagent immobilized thereon.

30. The cassette of claim 29, wherein said electrode is a carbon composite electrode.

31. The cassette of claim 26, wherein said cassette is a multi-well plate.

32. A method for detecting or measuring an analyte of interest in a sample in an electrochemiluminescence binding assay comprising:

(a) adding a liquid sample containing an analyte of interest to an assay cassette that comprises

(i) a porous assay electrode with a capture antibody immobilized thereon;

(ii) a dry reagent composition comprising a detection antibody comprising an electrochemiluminescent label, wherein said detection antibody is specific for said analyte of interest; and

(iii) an electrochemiluminescence coreactant;

wherein components (i), (ii) and (iii) are located in spatially distinct regions of said assay cassette;

(b) reconstituting said dry reagent composition in said liquid sample;

(c) contacting said electrode with said reconstituted dry reagent composition and said coreactant;

(d) applying a voltage waveform effective to trigger electrochemiluminescence at said electrode; and

(e) detecting or measuring electrochemiluminescence;

wherein said detected or measured electrochemiluminescence correlates to the presence or amount of said analyte in said sample.

33. The method of claim 32 wherein said reconstituted dry reagent composition is not washed from said electrode prior to step (d).

34. The method of claim 32 wherein said cassette is a multi-well plate.

35. The method of claim 32 wherein said electrode is a carbon composite electrode and said label is an organometallic ruthenium complex.

36. The method of claim 32 wherein said dry reagent composition contains at least one additional component selected from the group consisting of blocking agents, sugars, polysaccharides, surfactants, preservatives or buffering salts.

37. The method of claim 32 wherein said electrochemiluminescent coreactant is a tertiary amine.

38. The method of claim 37 wherein said amine is tripropylamine.

39. The method of claim 32 wherein said label is an organometallic ruthenium complex and said electrode is a carbon composite electrode.

48. The method of claim 32 wherein said capture antibody is in dry form.

40. A cassette for detecting or measuring an analyte of interest in a sample in an electrochemiluminescence binding assay comprising:

(i) a porous assay electrode with a capture antibody immobilized thereon;

(ii) a dry reagent composition comprising a detection antibody comprising an electrochemiluminescent label, wherein said detection antibody is specific for said analyte of interest; and

(iii) an electrochemiluminescence coreactant;

wherein components (i), (ii) and (iii) are located in spatially distinct regions of said assay cassette.

41. The cassette of claim 40 wherein said cassette is a multi-well plate.

42. The cassette of claim 40 wherein said electrode is a carbon composite electrode and said label is an organometallic ruthenium complex.

43. The cassette of claim 40 wherein said dry reagent composition contains at least one additional component selected from the group consisting of blocking agents, sugars, polysaccharides, surfactants, preservatives or buffering salts.

44. The cassette of claim 40 wherein said electrochemiluminescent coreactant is a tertiary amine.

45. The cassette of claim 44 wherein said amine is tripropylamine.

46. The cassette of claim 40 wherein said label is an organometallic ruthenium complex and said electrode is a carbon composite electrode.

47. The cassette of claim 40 wherein said capture antibody is in dry form.