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

• US 6,271,040 B1
• Filed: 07/30/1997
• Issued: 08/07/2001
• Est. Priority Date: 05/21/1992
• Status: Expired due to Fees

• Current Assignee: BIOSITE INCORPORATED (Abbott Laboratories)
• Original Assignee: Biosite Diagnostics Incorporated (Abbott Laboratories)
• Inventors: Buechler, Kenneth Francis
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/902,775
• Time in Patent Office: 1,469 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: 436/170
• 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: 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 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0851 Bottom walls
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• 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 2400/086 using baffles or other fixed flow obstructions
• CPC Class Codes: B01L 2400/088 by specific surface properties
• 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: 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 66/72321 : consisting of metals or their alloys
• CPC Class Codes: B29C 66/7234 : comprising a barrier layer
• CPC Class Codes: B29C 66/727 : being porous, e.g. foam
• CPC Class Codes: B29C 66/7392 : characterised by the material of at least one of the parts being a thermoplastic
• CPC Class Codes: B29C 66/73921 : characterised by the materials of both parts being thermoplastics
• CPC Class Codes: B29K 2001/00 : Use of cellulose, modified cellulose or cellulose derivatives, e.g. viscose, as moulding material
• CPC Class Codes: B29K 2023/00 : Use of polyalkenes or derivatives thereof as moulding material
• CPC Class Codes: B29K 2023/06 : PE, i.e. polyethylene
• CPC Class Codes: B29K 2023/12 : PP, i.e. polypropylene
• CPC Class Codes: B29K 2025/04 : Polymers of styrene
• CPC Class Codes: B29K 2025/06 : PS, i.e. polystyrene
• CPC Class Codes: B29K 2027/00 : Use of polyvinylhalogenides or derivatives thereof as moulding material
• CPC Class Codes: B29K 2027/12 : containing fluorine
• CPC Class Codes: B29K 2027/18 : PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• 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 2067/00 : Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2069/00 : Use of PC, i.e. polycarbonates or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2075/00 : Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2077/00 : Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2079/08 : PI, i.e. polyimides or derivatives thereof
• CPC Class Codes: B29K 2081/00 : Use of polymers having sulfur, with or without nitrogen, oxygen or carbon only, in the main chain, as moulding material
• CPC Class Codes: B29K 2083/00 : Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, 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 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: 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 comprising:

a housing having a top;

a sample port for receiving a sample, the sample port located on the housing;

a reagent within the housing and in fluid communication with the sample port, wherein the sample moves to contact the reagent, yielding a physically detectable change which correlates with the amount of a selected analyte in the sample; and

a diagnostic element within the housing in fluid communication with the reagent, the diagnostic element comprising a biosensor that produces a signal in response to the physically detectable change.

2. The device of claim 1 where the biosensor comprises an electrochemical transducer.

3. The device of claim 1 where the biosensor comprises an optical transducer.

4. The device of claim 1 where the biosensor comprises an electro-optical transducer.

5. The device of claim 1 where the biosensor comprises an acoustic/mechanical transducer.

6. The device of claim 1 where the biosensor utilizes potentiometric measurements.

7. The device of claim 1 where the biosensor utilizes amperometric measurements.

8. The device of claim 1 where the biosensor utilizes absorbance.

9. The device of claim 1 where the biosensor utilizes fluorescence.

10. The device of claim 1 where the biosensor utilizes luminescence.

11. The device of claim 1 where the biosensor utilizes evanescent waves.

12. The device of claim 1 where the biosensor comprises a piezoelectric crystal transducer.

13. The device of claim 1 where the biosensor utilizes surface acoustic waves.

14. The device of claim 1 where the biosensor comprises a field-effect transistor.

15. The device of claim 1 where the biosensor comprises a chemical field-effect transistor.

16. The device of claim 1 where the biosensor comprises an enzyme field-effect transistor.

17. The device of claim 1 where the biosensor detects a change in degree of agglutination of latex particles in the sample.

18. The device of claim 1 where the biosensor detects a change in viscosity of the sample.

19. The device of claim 1 where the assay device further comprises an electrical instrument.

20. The device of claim 1 where the assay device further comprises a visual display.

21. The device of claim 1 where the sample port is on the top of the housing.

22. The device of claim 1 where the sample moves to contact the reagent by a capillary action.

23. A method for detecting a target ligand using an assay device, the device comprising a housing that has a sample port, a reagent, and a diagnostic element in fluid communication with the reagent, the diagnostic element comprising a biosensor, the method comprising:

depositing a sample containing the target ligand into the sample port;

flowing the sample port from the sample port to the reagent;

reacting the sample and the reagent to create a physically detectable change; and

detecting the physically detectable change by generating a signal from the biosensor comprised in the diagnostic element.

24. The method of claim 23 further comprising the step of using the signal to create a visual indicia of the physically detectable change.

25. The method of claim 23, whereby sample flow occurs by capillary force.