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

• US 5,885,527 A
• Filed: 05/23/1995
• Issued: 03/23/1999
• Est. Priority Date: 05/21/1992
• Status: Expired due to Term

• Current Assignee: Quidel Cardiovascular, Inc. (Quidel Corporation)
• Original Assignee: Biosite Diagnostics Incorporated (Abbott Laboratories Incorporated)
• Inventors: Buechler, Kenneth F.
• Primary Examiner(s): Pyon, Harold Y.
• Application Number:
  US08/447,981
• Time in Patent Office: 1,400 Days
• Field of Search: 422/55, 422/56, 422/58, 422/72, 422/73, 422/82.05, 422/100, 422/102, 436/69, 436/180, 436/165, 436/170, 436/177, 436/518, 436/524, 436/531
• US Class Current: 422/412
• 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 3/50273 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 66/727 : being porous, e.g. foam
• 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 2033/12 : Polymers of methacrylic acid esters, e.g. PMMA, i.e. polymethylmethacrylate
• 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 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: Y10S 977/775 : Nanosized powder or flake, e.g. nanosized catalyst
• 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. Apparatus for blocking for a delay period fluid flow from a first zone to a second zone, said second zone adapted to receive fluid flow from said first zone through a time gate by capillary action, said time gate comprising at least one hydrophobic surface which is capable of binding at least one aqueous soluble component present in said fluid;

and whereby the delay period is related to the rate of binding of the aqueous soluble component to said hydrophobic surface which over the delay period changes said hydrophobic surface into a sufficiently hydrophilic surface to allow fluid to flow into said second zone.

3. Apparatus of claim 1 or 2 wherein said apparatus is embedded in a membrane.

4. Apparatus of claim 1 or 2 in which said component is a protein, polymer or detergent.

5. Apparatus of claim 1 or 2 in which said component is serum albumin.

6. Apparatus of claim 1 or 2 in which said component on said hydrophobic surface is latex particles.

7. Apparatus of claim 1 or 2 in which said hydrophobic surface is composed of a polyelectrolyte which becomes hydrophilic by exposure to the buffering capacity of said fluid and the timed fluid flow is related to the mass of polyelectrolyte and the buffering capacity and pH of said fluid.

2. Apparatus for blocking for a delay period fluid flow from a first zone to a second zone, said second zone adapted to receive fluid flow from said first zone through a time gate by hydrostatic pressure, said time gate comprising at least one hydrophobic surface which is capable of binding at least one aqueous soluble component present in said fluid;

and whereby the delay period is related to the rate of binding of the aqueous soluble component to said hydrophobic surface which over the delay period changes said hydrophobic surface into a sufficiently hydrophilic surface to allow fluid to flow into said second zone.

8. Apparatus for blocking for a delay period fluid flow from a first hydrophilic zone to a second hydrophilic zone, said second hydrophilic zone adapted to receive fluid flow from said first zone through a time gate, said apparatus comprising three distinct zones, a first hydrophilic zone, a hydrophobic zone and a second hydrophilic zone, said hydrophobic zone located between said first and second hydrophilic zones, and having a component therein which is capable of binding at least one aqueous soluble component present in said fluid at a rate which over the delay period changes said hydrophobic zone to a sufficiently hydrophilic surface wherein fluid flow is initially blocked from flowing into said second hydrophilic zone and after the delay period the fluid flows into said second hydrophilic zone.

9. Apparatus of claim 8 in which said component is a protein, polymer or detergent.

10. Apparatus of claim 8 in which said component is serum albumin.

11. Apparatus of claim 8 in which said component on said hydrophobic surface is latex particles.

12. Apparatus of claim 8 in which said hydrophobic surface is a polyelectrolyte which becomes hydrophilic by exposure to the buffering capacity of said fluid and the timed fluid flow is related to the mass of polyelectrolyte and the buffering capacity and pH of said fluid.