Multiple hybrid immunoassay

• US 10,641,767 B2
• Filed: 05/09/2018
• Issued: 05/05/2020
• Est. Priority Date: 07/29/2002
• Status: Expired due to Fees

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Inventors: Campbell, John Lewis Emerson, Frank, Pamela Anne, Hawkes, Meghan Elizabeth, Lobin, Shannon Reishma, Miller, Cary James, Yang, Zhen
• Primary Examiner(s): Brown, Melanie
• Application Number:
  US15/975,145
• Publication Number:
  US 20180259511A1
• Time in Patent Office: 727 Days
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: G01N 2333/47 Assays involving proteins of known structure or function as defined in the subgroups
• CPC Class Codes: G01N 2333/4712 Muscle proteins, e.g. myosin, actin, protein
• CPC Class Codes: G01N 2800/324 Coronary artery diseases, e.g. angina pectoris, myocardial infarction
• CPC Class Codes: G01N 33/53 Immunoassay; Biospecific binding assay; Materials therefor
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/543 with an insoluble carrier for immobilising immunochemicals
• CPC Class Codes: G01N 33/54313 the carrier being characterised by its particulate form
• CPC Class Codes: G01N 33/54353 with ligand attached to the carrier via a chemical coupling agent coatings G01N33/54393
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/545 Synthetic resin
• CPC Class Codes: G01N 33/6887 from muscle, cartilage or connective tissue
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere

Abstract

The invention relates to compositions and methods for the immunoassay of an analyte of interest. The analyte is detected in an immunoassay using three or more antibodies, where in each antibody specifically binds to a different epitope on the analyte. When the analyte of interest in a clinical marker for an acute disease, the detection of the analyte by immunoassay is a diagnosis of the occurrence of the disease.

Claims

1. A cartridge for sensing at least one analyte in a sample, said cartridge comprising:

a housing;

at least one sensor located within the housing;

a cavity within the housing including a sealed deformable pouch for retaining an aqueous reagent out of contact with the sensor;

an aqueous reagent conduit for connecting the cavity to the sensor;

aqueous reagent displacer under control of a reading apparatus for displacing the aqueous reagent from the cavity through the aqueous reagent conduit to the sensor;

sample holding chamber within the housing, for retaining the sample out of contact with the sensor, prior to sensing;

sample collector within the housing including an orifice for drawing the sample into the sample holding chamber;

a sample conduit connecting the sample holding chamber with the sensor;

sample displacer for forcibly displacing the sample from said sample holding chamber through the sample conduit and into contact with the sensor to permit sensing; and

an immunoassay composition for detecting said analyte comprising at least three different antibodies, the at least three different antibodies being capable of binding to at least three different epitopes on said analyte, in which at least two of the at least three different antibodies are capable of binding to at least two different epitopes on a subform of said analyte, and in which at least one of the at least three different epitopes on said analyte is unavailable for binding on the subform.

2. The cartridge of claim 1, wherein said analyte is human cTnI and wherein the sample is a whole blood sample.

3. The cartridge of claim 1, wherein said at least three different antibodies comprise:

(a) G129C antibody;

(b) G130C antibody; and

(c) at least one additional troponin I antibody different from (a) and (b).

4. The cartridge of claim 2, wherein (c) is selected from the group consisting of 19C7, A34720, 8E10, A34500, A34440, A34730, and 34503228P.