Diagnostic devices and apparatus for the controlled movement of reagents without membranes

• US 7,824,611 B2
• Filed: 10/29/2003
• Issued: 11/02/2010
• Est. Priority Date: 05/21/1992
• Status: Expired due to Fees

• Current Assignee: Alere San Diego Incorporated (Abbott Laboratories)
• Original Assignee: BIOSITE INCORPORATED (Abbott Laboratories)
• Inventors: Buechler, Kenneth F.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US10/697,351
• Publication Number:
  US 20040077103A1
• Time in Patent Office: 2,561 Days
• Field of Search: 422/56, 422/58, 422/61, 422/164, 422/177, 422/518
• US Class Current: 435/287.1
• CPC Class Codes: B01L 2200/0621 Control of the sequence of chambers filled or emptied
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/089 Virtual walls for guiding liquids
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0688 surface tension valves, capillary stop, capillary break
• CPC Class Codes: B01L 2400/086 using baffles or other fixed flow obstructions
• CPC Class Codes: B01L 2400/088 by specific surface properties
• 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 33/54387 Immunochromatographic test strips
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

The assay devices, assay systems and device components of this invention comprise at least two opposing surfaces disposed a capillary distance apart, at least one of which is capable of immobilizing at least one target ligand or a conjugate in an amount related to the presence or amount of target ligand in the sample from a fluid sample in a zone for controlled fluid movement to, through or away the zone. The inventive device components may be incorporated into conventional assay devices with membranes or may be used in the inventive membrane-less devices herein described and claimed. These components include flow control elements, measurement elements, time gates, elements for the elimination of pipetting steps, and generally, elements for the controlled flow, timing, delivery, incubation, separation, washing and other steps of the assay process.

Claims

1. A device for detecting one or more target ligands in a sample, comprising:

a nonporous surface comprising one or more particles immobilized to said surface,

wherein said particles comprise antibodies or fragments thereof immobilized to said particles,

wherein the antibodies or fragments thereof bind specifically to said one or more target ligands,

wherein said particle size range is from 1 nm to 5 μ

m, wherein said surface is a textured surface comprising one or more depressions and/or protrusions extending between 1 nm and 0.5 mm from said surface, wherein one or more of said particles are entrapped within depressions and/or between protrusions on the textured surface, and

wherein said assay device comprises a capillary space between said nonporous surface and a second surface spaced at a capillary forming distance from said nonporous surface.

2. An assay device according to claim 1, wherein said particles are selected from the group consisting of latex particles, silica particles, zirconia particles, alumina particles, titania particles, ceria particles, metal sol particles, and polystyrene particles.

3. The assay device according to claim 1, wherein the capillary forming distance is from 0.01 mm to 0.2 mm.