Apparatus and methods for analyte measurement and immunoassay

• US 8,222,024 B2
• Filed: 08/04/2011
• Issued: 07/17/2012
• Est. Priority Date: 03/05/2002
• Status: Expired due to Term

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Davis, Graham, Lauks, Imants, Lin, Chao, Miller, Cary James
• Primary Examiner(s): Yu, Melanie J
• Application Number:
  US13/198,253
• Publication Number:
  US 20110290669A1
• Time in Patent Office: 348 Days
• Field of Search: 435/7.1, 435/283.1, 435/285.2, 435/287.1, 435/287.2, 435/288.5, 436/518, 422/50, 422/81, 422/82.01
• US Class Current: 435/288.5
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0421 electrophoretic flow
• CPC Class Codes: B01L 2400/046 Chemical or electrochemical formation of bubbles
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/502723 characterised by venting arrangements
• 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: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: G01N 2035/0436 with pre-packaged reagents, i.e. test-packs
• CPC Class Codes: G01N 33/543 with an insoluble carrier for immobilising immunochemicals
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 35/08 using a stream of discrete samples flowing along a tube system, e.g. flow injection analysis

Abstract

The present invention relates to an apparatus for conducting a variety of assays for the determination of analytes in liquid samples, and relates to the methods for such assays. In particular, the invention relates to a single-use cartridge designed to be adaptable to a variety of real-time assay protocols, preferably assays for the determination of analytes in biological samples using immunosensors or other ligand/ligand receptor-based biosensor embodiments. The cartridge provides novel features for processing a metered portion of a sample, for precise and flexible control of the movement of a sample or second fluid within the cartridge, for the amending of solutions with additional compounds during an assay, and for the construction of immunosensors capable of adaptation to diverse analyte measurements. The disclosed device and methods of use enjoy substantial benefits over the prior art, including simplicity of use by an operator, rapid in situ determinations of one or more analytes, and single-use methodology that minimizes the risk of contamination of both operator and patient. The disclosed invention is adaptable to the point-of-care clinical diagnostic field, including use in accident sites, emergency rooms, surgery, nursing homes, intensive care units, and non-medical environments.

Claims

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

a sample holding chamber for receiving said sample and retaining said sample;

a first conduit connected to said sample holding chamber;

at least one analyte sensor, wherein said sensor comprises an analyte-responsive surface and said surface is within said first conduit;

a first and second vent within said first conduit wherein said sensor is positioned between said sample chamber and said vents;

a second conduit for retaining a fluid, said second conduit connected to said first conduit between said sample chamber and said vents;

pump means capable of displacing said sample from said holding chamber into said first conduit and further capable of closing said second vent to retain said sample in the region of said second vent; and

wherein said pump means is further capable of displacing said fluid from said second conduit into said first conduit, and wherein said first vent permits at least one air segment to enter said fluid.

2. The cartridge of claim 1, wherein said pump means comprises a variable rate of displacement whereby the volume and number of air segments that enter the fluid is controlled.

3. The cartridge of claim 1, wherein the second conduit comprises a vent.

4. The cartridge of claim 1, wherein the sample contacts an adsorbent wicking material in proximity to second vent and is thereby retained and closes said vent.

5. The cartridge of claim 1, wherein the sample chamber further comprises a sample-metering element for providing a predetermined volume of sample to said first conduit.

6. The cartridge of claim 1, wherein said fluid in said second conduit is initially in a rupturable pouch.

7. The cartridge of claim 1 or claim 6, further comprising a reader device, said reader capable (a) of controlling and reading said analyte sensor, (b) of controlling said pump means, and (c) of controlling said rupturable pouch.

8. The cartridge of claim 1, wherein said first vent comprises a gas permeable membrane capable of controlling the rate of air entry through said first vent.

9. The cartridge of claim 1, wherein said analyte sensor is an electrochemical immunosensor comprising an electrode having a layer of immobilized first antibody that binds said analyte and further comprising a counter/reference electrode.