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

• US 7,615,191 B2
• Filed: 12/22/2004
• Issued: 11/10/2009
• Est. Priority Date: 05/21/1992
• Status: Expired due to Fees

• Current Assignee: BIOSITE INCORPORATED (Abbott Laboratories Incorporated)
• Original Assignee: BIOSITE INCORPORATED (Abbott Laboratories Incorporated)
• Inventors: Buechler, Kenneth F.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US11/022,297
• Publication Number:
  US 20050136552A1
• Time in Patent Office: 1,784 Days
• Field of Search: 422/58, 422/61, 436/177, 436/524
• US Class Current: 422/412
• CPC Class Codes: B01L 2200/0621 Control of the sequence of chambers filled or emptied
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2300/041 Connecting closures to device or container
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/089 Virtual walls for guiding liquids
• 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 3/502746 characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/806 Electrical property or magnetic property
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

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 comprising:

a) a sample addition zone on a surface of said device;

b) an array of posts protruding from between 10 nm and 0.5 mm on said device surface;

c) one or more capture zones on said device surface, said capture zones comprising reagents to bind to or react with one or more analytes of interest; and

d) a filter configured to separate plasma from red blood cells;

wherein said filter, array of posts and one or more capture zones are in fluid communication with said sample addition zone,

wherein said posts are configured and arranged to provide flow of a sample fluid applied to said sample addition zone through said array of posts by capillary force; and

wherein said filter is configured and arranged to receive said sample fluid prior to flow of said sample fluid through said array of posts such that sample fluid flowing through said array of posts is filtered prior to flow.

2. A device according to claim 1, comprising one or more reagents dried on said device surface, wherein said device surface is configured and arranged to provide reconstitution of said reagents into said sample fluid.

3. A device according to claim 1, wherein said reagents comprise antibodies or binding fragments thereof selected to bind to one or more of said analytes of interest immobilized at said capture zone.

4. A device according to claim 1, wherein said device surface is molded from a polymeric material.

5. A device according to claim 4, wherein said device surface is formed by copying a master.

6. A device according to claim 1, further comprising a lid overlaying said device surface.

7. A device according to claim 3, wherein said antibodies are provided on particles that are immobilized on said device surface.

8. A device according to claim 3, wherein one or more of said capture zones comprise one or more posts of said array of posts.

9. A device according to claim 1, further comprising a receptor conjugate that binds to one or more of said analytes of interest.

10. A device according to claim 1, further comprising a capillary space formed between said device surface and an opposing surface overlaying all or a portion of said device surface.

11. A device according to claim 1, further comprising a used reagent reservoir positioned on a flow path distal to one or more of said capture zones and said sample addition zone.