Diagnostic devices for the controlled movement of reagents without membranes

• US 7,524,456 B1
• Filed: 07/11/2000
• Issued: 04/28/2009
• Est. Priority Date: 05/21/1992
• Status: Expired due to Fees

• Current Assignee: BIOSITE INCORPORATED (Abbott Laboratories)
• Original Assignee: BIOSITE INCORPORATED (Abbott Laboratories)
• Inventors: Buechler, Kenneth F.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/613,650
• Time in Patent Office: 3,213 Days
• Field of Search: 422/58, 422/61, 422/82.05, 422/100, 422/102, 422/73, 436/524, 436/531, 436/533, 436/165, 436/177
• US Class Current: 422/412
• CPC Class Codes: B01D 15/3804 Affinity chromatography
• CPC Class Codes: B01J 2219/00605 the compounds being directly bound or immobilised to solid supports
• CPC Class Codes: B01J 2219/0061 The surface being organic
• CPC Class Codes: B01J 2219/00619 using hydrophilic or hydrophobic regions
• CPC Class Codes: B01J 2219/00635 by reactive plasma treatment
• CPC Class Codes: B01J 2219/00648 by the use of solid beads
• CPC Class Codes: B01J 2219/00659 Two-dimensional arrays
• CPC Class Codes: B01J 2219/00725 Peptides
• CPC Class Codes: B01J 2219/0074 Biological products
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/0621 Control of the sequence of chambers filled or emptied
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/089 Virtual walls for guiding liquids
• CPC Class Codes: B01L 2300/165 Specific details about hydrophobic, oleophobic surfaces
• CPC Class Codes: B01L 2400/0406 capillary forces
• 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 3/502707 : characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• 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: B01L 3/502746 : characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• CPC Class Codes: B29C 65/08 : using ultrasonic vibrations non-plastics element to plastics elements B29C65/645
• CPC Class Codes: B29C 65/7829 : said distance pieces being integral with at least one of the parts to be joined
• CPC Class Codes: B29C 65/8253 : by the use of waves or particle radiation, e.g. visual examination, scanning electron microscopy, or X-rays B29C65/8292 takes precedence
• CPC Class Codes: B29C 66/112 : Single lapped joints
• CPC Class Codes: B29C 66/1122 : Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/114 : Single butt joints
• CPC Class Codes: B29C 66/30223 : said melt initiators being rib-like
• CPC Class Codes: B29C 66/53461 : joining substantially flat covers and/or substantially flat bottoms to open ends of container bodies
• CPC Class Codes: B29L 2031/756 : Microarticles, nanoarticles
• CPC Class Codes: G01N 2035/00237 : Handling microquantities of analyte, e.g. microvalves, capillary networks
• CPC Class Codes: G01N 30/02 : Column chromatography
• CPC Class Codes: G01N 33/54366 : Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 35/00 : Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
• CPC Class Codes: G01N 35/085 : Flow Injection Analysis
• 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. An assay device for detecting a plurality of target ligands in a sample, comprising:

a nonporous textured surface, said nonporous textured surface comprising one or more depressions or protrusions extending between 1 nm and 0.5 mm from said nonporous textured surface; and

a plurality of discrete capture zones on said surface, each said capture zone comprising receptors immobilized to said surface or immobilized on particles immobilized to said surface, wherein said particle size range is from 1 nm to 5 μ

m, and wherein said receptors are capable of binding one or more of said plurality of target ligands,

wherein said capture zones occupy one or more discrete hydrophilic regions of said surface delimited by an adjacent hydrophobic region of said surface.

2. An assay device according to claim 1, wherein each said discrete capture zone comprises receptors independently selected from the group consisting of antibodies, antibody fragments, nucleic acid molecules, and chelators.

3. An assay device according to claim 1, wherein each said discrete capture zone binds a different target ligand from amongst said plurality of target ligands.

4. An assay device according to claim 3, wherein said plurality of target ligands are a plurality of nucleic acid molecules, and each said discrete capture zone comprises a nucleic acid molecule having a nucleotide sequence that is complementary to one of said plurality of nucleic acid molecules.

5. An assay device according to claim 3, wherein each said discrete capture zone comprises an antibody, or a fragment thereof, capable of binding one of said plurality of target ligands.

6. An assay device according to claim 1, wherein one or more of said discrete capture zones comprise one or more particles immobilized to said surface, wherein said receptors are immobilized on said particles.

7. An assay device according to claim 6, wherein said receptors are antibodies, or fragments thereof.

8. An assay device according to claim 6, wherein said surface is a said textured surface, and one or more of said particles are entrapped within depressions and/or between protrusions on the textured surface.

9. An assay device according to claim 6, 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.

10. An assay device according to any one of claims 1-9, wherein said nonporous surface forms a capillary space between said nonporous surface and a second surface spaced at a capillary forming distance from said nonporous surface.

11. An assay device according to any one of claims 1-9, wherein said nonporous surface is not part of a capillary space.

12. An assay device for detecting a plurality of target ligands in a sample, comprising:

a nonporous textured surface, said nonporous textured surface comprising one or more depressions or protrusions extending between 1 nm and 0.5 mm from said nonporous textured surface; and

a plurality of discrete capture zones on said surface, each said capture zone comprising receptors immobilized thereon to said surface or immobilized on particles immobilized to said surface, wherein said particle size range is from 1 nm to 5 μ

m, and wherein said receptors are capable of binding one or more of said plurality of target ligands,

wherein said capture zones are located in one more diagnostic elements of said surface, said diagnostic elements being hydrophilic and delimited by one or more adjacent hydrophobic regions of said surface.

13. An assay device according to claim 12, wherein each said discrete capture zone comprises receptors independently selected from the group consisting of antibodies, antibody fragments, nucleic acid molecules, and chelators.

14. An assay device according to claim 12, wherein each said discrete capture zone binds a different target ligand from amongst said plurality of target ligands.

15. An assay device according to claim 14, wherein said plurality of target ligands are a plurality of nucleic acid molecules, and each said discrete capture zone comprises a nucleic acid molecule having a nucleotide sequence that is complementary to one of said plurality of nucleic acid molecules.

16. An assay device according to claim 14, wherein each said discrete capture zone comprises an antibody, or a fragment thereof, capable of binding one of said plurality of target ligands.

17. An assay device according to claim 12, wherein one or more of said discrete capture zones comprise one or more particles immobilized to said surface, wherein said receptors are immobilized on said particles.

18. An assay device according to claim 17, wherein said receptors are antibodies, or fragments thereof.

19. An assay device according to claim 17, wherein said surface is said textured surface, and one or more of said particles are entrapped within depressions and/or between protrusions on the textured surface.

20. An assay device according to claim 17, 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.