Methods and apparatus for conducting multiple measurements on a sample

• US 7,858,321 B2
• Filed: 09/10/2002
• Issued: 12/28/2010
• Est. Priority Date: 09/10/2001
• Status: Active Grant

• Current Assignee: Meso Scale Technologies, LLC
• Original Assignee: Meso Scale Technologies, LLC
• Inventors: Wohlstadter, Jacob N., Wilbur, James, Glezer, Eli N., Debad, Jeff D., Biebuyck, Hans, Johnson, Kent, Sigal, George, Umek, Robert M., Kenten, John H., Sardesai, Niranjan Y., Eason, Paula Denney, Tsionsky, Michael
• Primary Examiner(s): BROWN, MELANIE YU
• Application Number:
  US10/238,391
• Publication Number:
  US 20030113713A1
• Time in Patent Office: 3,031 Days
• Field of Search: 435/4, 435/7.1, 435/7.9, 435/7.92, 435/7.93, 435/7.94, 435/283.1, 435/287.2, 435/288.1, 435/288.2, 435/288.4, 435/288.3, 435/288.7, 436/518, 436/528, 436/164, 436/807, 422/50, 422/55, 422/58, 422/61, 422/68.1, 422/82.05
• US Class Current: 435/7.1
• CPC Class Codes: C12Q 1/485 involving kinase
• CPC Class Codes: G01N 2333/11 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: G01N 2333/135 Respiratory syncytial virus
• CPC Class Codes: G01N 2333/16 HIV-1, HIV-2
• CPC Class Codes: G01N 2333/525 Tumor necrosis factor [TNF]
• CPC Class Codes: G01N 2333/5412 IL-6
• CPC Class Codes: G01N 2333/545 IL-1
• CPC Class Codes: G01N 2333/57 IFN-gamma
• CPC Class Codes: G01N 2333/71 for growth factors; for growth regulators
• CPC Class Codes: G01N 2333/9121 with an alcohol group as acceptor (2.7.1), e.g. general tyrosine, serine or threonine kinases
• CPC Class Codes: G01N 33/5304 Reaction vessels, e.g. agglutination plates for solid-phase systems G01N33/543
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54373 involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
• CPC Class Codes: G01N 33/5438 Electrodes
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/56944 Streptococcus
• CPC Class Codes: G01N 33/56983 Viruses
• CPC Class Codes: G01N 33/56988 HIV or HTLV
• CPC Class Codes: G01N 33/573 for enzymes or isoenzymes
• CPC Class Codes: G01N 33/68 involving proteins, peptides or amino acids involving lipoproteins G01N33/92
• CPC Class Codes: G01N 33/6803 : General methods of protein analysis not limited to specific proteins or families of proteins
• CPC Class Codes: G01N 33/6842 : Proteomic analysis of subsets of protein mixtures with reduced complexity, e.g. membrane proteins, phosphoproteins, organelle proteins
• CPC Class Codes: G01N 33/6845 : Methods of identifying protein-protein interactions in protein mixtures
• CPC Class Codes: Y10S 436/807 : Apparatus included in process claim, e.g. physical support structures

Abstract

Multiplexed test measurements are conducted using an assay module having a plurality of assay domains. In preferred embodiments, these measurements are conducted in assay modules 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. A method for assaying for an analyte of interest comprising

(a) introducing a sample comprising said analyte into a multi-well plate having a plurality of wells and at least two assay domains located within a single well of said plurality wells, said at least two assay domains including (i) a first domain comprising a first component that binds said analyte, and (ii) a second domain comprising a second component that competes with said analyte;

(b) conducting in said single well a sandwich assay and a competitive assay, wherein the amount of said analyte is separately quantified in said sandwich assay and said competitive assay; and

(c) comparing the amounts of said analyte identified in step (b) in said sandwich and said competitive assays to determine if a dynamic range of said sandwich assay has been exceeded.

2. The method of claim 1, wherein said first assay domain comprises a binding reagent capable of binding to said analyte and participating in the formation of a sandwich complex that includes said analyte, and said second assay domain comprises a binding reagent that competes with said analyte.

3. The method of claim 1, wherein said second assay domain comprises a moiety selected from the group consisting of said analyte, an analogue of said analyte and combinations thereof.

4. The method of claim 2, wherein said binding reagent in said competitive assay comprises an analog of said analyte, said analog does not comprise the epitope recognized by said binding reagent in said sandwhich assay.

5. A method for assaying for an analyte of interest, the method comprising:

(a) introducing a sample comprising said analyte into an assay module comprising a plurality of particles including;

(i) a first particle comprising a first assay domain including a first component that binds said analyte, and (ii) a second particle comprising a second assay domain including a second component that competes with said analyte;

(b) conducting, simultaneously, in said assay module a sandwich assay and a competitive assay, wherein the amount of said analyte is separately quantified in said sandwich assay and said competitive assay; and

(c) comparing the amounts of said analyte identified in step (b) in said sandwich and said competitive assays to determine if a dynamic range of said sandwich assay has been exceeded.

6. The method of claim 5, wherein said first assay domain comprises a binding reagent capable of binding to said analyte and participating in the formation of a sandwich complex that includes said analyte, and said second assay domain comprises a binding reagent that competes with said analyte.

7. The method of claim 5, wherein said second assay domain comprises a moiety selected from the group consisting of said analyte, an analogue of said analyte and combinations thereof.

8. The method of claim 6, wherein said binding reagent in said competitive assay comprises an analog of said analyte, said analog does not comprise the epitope recognized by said binding reagent in said sandwich assay.