Non-porous diagnostic devices for the controlled movement of reagents

• US 6,143,576 A
• Filed: 03/03/1997
• Issued: 11/07/2000
• Est. Priority Date: 05/21/1992
• Status: Expired due to Term

• Current Assignee: BIOSITE INCORPORATED (Abbott Laboratories Incorporated)
• Original Assignee: Biosite Diagnostics Incorporated (Abbott Laboratories Incorporated)
• Inventors: Buechler, Kenneth F.
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US08/810,569
• Time in Patent Office: 1,345 Days
• Field of Search: 422/56, 422/57, 422/58, 422/60, 435/7.1, 435/7.92, 435/7.93, 435/7.94, 435/7.95, 435/287.2, 435/287.3, 435/287.7, 435/287.9, 435/288.5, 436/518, 436/523, 436/525, 436/527, 436/530, 436/533, 436/541, 436/810, 436/818
• US Class Current: 436/518
• CPC Class Codes: B01D 15/3804 Affinity chromatography
• CPC Class Codes: B01J 19/0093 Microreactors, e.g. miniaturised or microfabricated reactors laboratory containers with capillary fluid transport in microfabricated channels or chambers B01L3/5027
• CPC Class Codes: B01J 2219/00828 Silicon wafers or plates
• CPC Class Codes: B01J 2219/00833 Plastic
• CPC Class Codes: B01J 2219/00844 Comprising porous material
• CPC Class Codes: B01J 2219/00889 Mixing micromixers B01F33/30
• CPC Class Codes: B01J 2219/00932 Sonic or ultrasonic vibrations
• CPC Class Codes: B01J 2219/00952 Sensing operations
• 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 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/089 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 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 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 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: B29C 66/54 : Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles
• CPC Class Codes: B29C 66/61 : Joining from or joining on the inside for making tubes by bending sheets and joining from the inside B29C53/387
• CPC Class Codes: B29C 66/71 : characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/73921 : characterised by the materials of both parts being thermoplastics
• CPC Class Codes: B29K 2025/06 : PS, i.e. polystyrene
• CPC Class Codes: B29K 2033/08 : Polymers of acrylic acid esters, e.g. PMA, i.e. polymethylacrylate
• CPC Class Codes: B29K 2069/00 : Use of PC, i.e. polycarbonates or derivatives thereof, as moulding material
• 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 2333/59 : Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
• 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 33/558 : using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• 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: Y10S 436/81 : Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/818 : Human chorionic gonadotropin
• CPC Class Codes: Y10S 977/801 : Drug
• CPC Class Codes: Y10S 977/906 : Drug delivery
• CPC Class Codes: Y10S 977/92 : Detection of biochemical

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 diagnostic assay device for detecting a target ligand in a reaction mixture, said device comprising:

i. a sample addition reservoir;

ii. a non-porous diagnostic element located within a capillary space, through which all of said reaction mixture flows, wherein said reaction mixture flows from said sample addition reservoir to said diagnostic element without application of an external force, and wherein said diagnostic element immobilizes for detection at least one conjugate in an amount related to the amount of target ligand in the reaction mixture in at least one zone.

2. A test device comprising:

i) a sample addition reservoir comprising a capillary space;

ii) a diagnostic element comprising two non-porous surfaces that form a capillary of from 1 micron to 100 microns and having at least one zone comprised of a biological material which reacts with a target ligand or a conjugate of the target ligand; and

iii) a used reagent reservoir,

wherein when a reaction mixture is added to said sample addition reservoir, said reaction mixture flows through said diagnostic element to said used reagent reservoir such that substantially all of said reaction mixture passes over said at least one zone in said diagnostic element and an amount of the target ligand present in said reaction mixture related to the presence or amount of the target ligand in said reaction mixture is captured for detection in said at least one zone in said diagnostic element.

3. A diagnostic assay device comprising:

a diagnostic element having a nonabsorbent surface for detection of at least one target ligand in at least one zone, the nonabsorbent surface having particles immobilized thereon, which particles comprise receptor that reacts with said at least one target ligand, wherein when a reaction mixture comprising said at least one target ligand is added to the device, said reaction mixture contacts said immobilized particles, and an amount of said at least one target ligand is captured for detection by said receptor.

4. The device of claim 3 wherein the particles are latex.

5. The device of claim 3 wherein the particles are polystyrene.

6. The device of claim 3 wherein the particles are nanoparticles.

7. The device of claim 6 wherein the nanoparticles comprise silica, zirconia, alumina, titania, ceria, metal sols, or polystyrene.

8. The device of claim 6 wherein the nanoparticles have sizes in a range from about 1 nm to 100 nm.

9. The device of claim 6 wherein the nanoparticles are immobilized on said nonabsorbent surface through adsorption or covalent bonds.

10. The device of claim 3 wherein said particles are immobilized on said nonabsorbent surface by magnetic means, hydrophobic means, hydrogen bonding, electrostatic means, or entrapment.

11. The device of claim 3, wherein said particles have diameters ranging from about 0.1 mm to 10 mm.

12. The device of claim 3, wherein said device comprises the form of a dipstick.

13. The device of claim 3, wherein said receptor is immobilized on a surface of the particle.

14. The device of claim 13, wherein said surface binds a proteinaceous component.

15. The device of claim 14, wherein said surface binds gelatin, serum albumins, immunoglobulins, enzymes, polypeptides, and hydrophilic polymers.

16. The device of claim 15, wherein said surface binds bovine serum albumin.

17. The device of claim 3, wherein said receptor comprises an antibody.

18. The device of claim 17, wherein said receptor comprises a monoclonal antibody.

19. The device of claim 17, wherein said receptor comprises a goat Immunoglobulin G antibody that binds mouse Immunoglobulin G.

20. A device of claim 18, wherein said receptor comprises an anti human chorionic gonadotropin α

-subunit monoclonal antibody.

21. The device of claim 18, wherein said receptor comprises an anti-phencyclidine monoclonal antibody.