Multi-array, multi-specific electrochemiluminescence testing

• US 7,015,046 B2
• Filed: 10/24/2003
• Issued: 03/21/2006
• Est. Priority Date: 03/10/1995
• Status: Expired due to Fees

• Current Assignee: Meso Scale Technologies, LLC
• Original Assignee: Meso Scale Technologies, LLC
• Inventors: Helms, Larry R., Wohlstadter, Jacob N., Wilbur, James, Martin, Mark, Fischer, Alan, Sigal, George, Guo, Liang-Hong, Billadeau, Mark A., Leland, Jon, Darvari, Ramin
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US10/693,441
• Publication Number:
  US 20040086423A1
• Time in Patent Office: 879 Days
• Field of Search: 204/400, 204/403, 204/290.R, 204/291, 204/294, 422/55, 422/57, 422/58, 435/6, 435/7.9, 435/287.1, 435/287.2, 435/288.7, 435/808, 435/7.92, 435/7.93, 435/7.94, 436/164, 436/172, 436/512, 436/518, 436/524, 436/525, 436/805
• US Class Current: 436/172
• 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 conducting an electrochemiluminescence binding assay for detecting or measuring an analyte of interest in a sample comprising:

(a) contacting an assay electrode with a sample and a component of said assay linked to an electrochemiluminescent label, said assay electrode;

(i) comprising a composite containing a polymer matrix and a multiplicity of carbon particles dispersed therein; and

(ii) having a binding domain containing a binding reagent, wherein said binding reagent is immobilized on said electrode;

(b) applying a voltage waveform effective to trigger electrochemiluminescence at said binding domain in the presence of a reaction medium suitable for conducting an electrochemiluminescence assay; and

(c) detecting or measuring electrochemiluminescence from said binding domain;

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 the carbon particles comprise from 0.5% to 50% by weight of the composite.

3. The method of claim 1, wherein the carbon particles comprise from 1% to 30% by weight of the composite.

4. The method of claim 1, wherein said binding reagent is covalently bound to said assay electrode.

5. The method of claim 1, wherein said binding reagent is non-covalently bound to said assay electrode.

6. The method of claim 1, wherein said binding reagent is directly immobilized on said assay electrode.

7. The method of claim 1, wherein said binding reagent is indirectly immobilized on said assay electrode via a binding pair.

8. The method of claim 1, wherein said assay electrode includes at least one additional binding domain.

9. The method of claim 1, wherein said binding reagent comprises an antibody or fragment thereof, a nucleic acid, a receptor or an enzyme.

10. The method of claim 1, wherein said electrode comprises one or more additional binding domains having different binding specificities to provide for simultaneous binding of a plurality of different analytes of interest present in said sample.

11. The method of claim 1, wherein said sample is a metered volume of sample.

12. The method of claim 1, further including a wash step.

13. The method of claim 1, further including a calibration step.

14. The method of claim 1, wherein one component of the assay is stored in dry form and reconstituted by the sample.

15. The method of claim 1, wherein said voltage is applied to two of said electrodes at different times.

16. The method of claim 1, wherein said reaction medium includes an ECL coreactant.

17. The method of claim 1, wherein said electrochemi-luminescent label is capable of repeatedly emitting electrochemiluminescence.

18. The method of claim 1, wherein said electrochemi-luminescent label comprises a metal.

19. The method of claim 1, wherein said electrochemi-luminescent label comprises an organometallic compound.

20. The method of claim 1, wherein said electrochemi-luminescent label comprises an organometallic compound selected from the group consisting of Ru-containing and Os-containing organometallic compounds.

21. The method of claim 1, wherein, when said sample comprises said analyte, said contacting step results in the formation of a sandwich complex comprising said binding reagent, said analyte and said component.

22. The method of claim 1, wherein said analyte competes with said component for binding to said binding reagent.

23. The method of claim 1, wherein said analyte competes with said binding reagent for binding said component.

24. The method of claim 1, wherein said analyte binds to said binding reagent.

25. The method of claim 1, wherein said analyte binds said component.

26. The method of claim 1, wherein said analyte binds said binding reagent and said component.

27. A method for conducting electrochemiluminescence binding assays for detecting or measuring a plurality of analytes of interest in a sample comprising:

(a) contacting an assay electrode with a sample and one or more assay components linked to electrochemiluminescent labels, said assay electrode;

(i) comprising a composite containing a polymer matrix and a multiplicity of carbon particles dispersed therein; and

(ii) having a plurality of binding domains containing binding reagents, wherein said binding reagents are immobilized on said electrode;

(b) applying a voltage waveform effective to trigger electrochemiluminescence at said binding domains in the presence of a reaction medium suitable for conducting an electrochemiluminescence assay; and

(c) detecting or measuring electrochemiluminescence from said binding domains;

wherein said detected or measured electrochemiluminescence at said binding domains correlates to the presence or amount of said analytes in said sample.

28. The method of claim 27, wherein at least two of said binding domains comprise binding reagents that differ in specificity for analytes of interest.

29. The method of claim 27, wherein the measured electrochemiluminescence at a first of said binding domains correlates with the presence or amount of a first analyte and the measured electrochemiluminescence at a second of said binding domains correlates with the presence or amount of a second analyte.