Disposable device in diagnostic assays

• US 5,660,993 A
• Filed: 08/24/1994
• Issued: 08/26/1997
• Est. Priority Date: 02/18/1993
• Status: Expired due to Fees

• Current Assignee: Biocircuits Corporation
• Original Assignee: Biocircuits Corporation
• Inventors: Saul, Tom, Langford, Jeffrey B., Cathey, Cheryl A., Ribi, Hans O., Bloom, Nicole D., Schwartz, Henry L.
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): Chin, Christopher L.
• Application Number:
  US08/296,489
• Time in Patent Office: 1,098 Days
• Field of Search: 422/55, 422/57, 422/58, 422/61, 435/7, 435/9, 435/810, 435/973, 435/287.1, 435/287.2, 435/288.1, 435/288.2, 435/288.3, 435/288.4, 435/288.5, 436/164, 436/165, 436/514, 436/518, 436/524, 436/527, 436/528, 436/805, 436/807, 436/808, 436/810
• US Class Current: 435/7.9
• CPC Class Codes: B01F 33/30 Micromixers
• CPC Class Codes: B01F 33/452 using independent floating stirring elements
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• 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 3/5027 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 3/50273 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: G01N 2035/00267 Meltable plugs
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/973 Simultaneous determination of more than one analyte
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/81 : Tube, bottle, or dipstick

Abstract

A disposable diagnostic assay device and method for its use are provided. The device comprises a sample addition port in fluid communication with at least one main channel. The main channel comprises, in the direction of fluid flow, a main reagent area in fluid communication with an incubation area and a waste area. In fluid communication with the main channel is at least one side reagent channel. The side reagent channels comprise, in the direction of fluid flow, a liquid addition port and a side reagent area in fluid communication with the main channel at a region of the main channel upstream from the incubation area. Agitation means may be included in the at least one of the main and side reagent areas and/or the incubation area. Capillary valves may be located at various positions along the main and side reagent channels upstream from the incubation area, providing for control over fluid flow through the device. Applications in which the device finds use include diagnostic assays employing signal producing systems based on the interactions of specific binding pair members, where optical signals are related to the presence of analyte.

Claims

1. A disposable assay device for use in analyte detection, said device comprising:

a sample addition port in fluid communication with at least one main channel, wherein at least a portion of said main channel is a capillary and said main channel comprises;

at least one reagent incubation area; and

a waste area, wherein said waste area is downstream from said incubation area; and

at least one side channel, said side channel comprising;

a liquid addition port; and

a side reagent area downstream from said liquid addition port;

wherein said side reagent area of said side channel is in fluid communication with said main channel at a region of said main channel upstream from said waste area and wherein said device further comprises agitation means in at least one of said main channel or side reagent area.

2. The device according to claim 1, wherein said device further comprises at least one capillary valve positioned along said main channel or side reagent channel upstream from said incubation area.

3. The device according to claim 1, wherein said device comprises a plurality of main channels in fluid communication with said sample addition port.

4. The device according to claim 1, wherein said main channel comprises a plurality of incubation areas upstream from said waste area.

5. A disposable assay device for use in analyte detection in a fluid sample, said device comprising:

a housing comprising top and bottom plates fastened together, wherein said fastened together top and bottom plates comprise;

a sample addition port in fluid communication with a main channel comprising in a first direction of fluid flow from said sample addition port;

a main reagent area comprising agitation means;

a transport channel;

an incubation area; and

a waste area;

wherein said main channel comprises at least one capillary valve upstream from said incubation area;

a side reagent channel on either side of said main channel, wherein each of said side reagent channels comprised in a second direction of fluid flow;

a liquid addition port;

a side reagent area comprising agitation means; and

a side reagent transport channel, wherein said side reagent transport channel is in fluid communication with said main channel at a region upstream from said waste area;

an optically clear window above said incubation area; and

members of a signal producing system in at least one of said main reagent channel and side reagent channels, wherein said signal producing system produces an optical signal which is related to the presence of analyte in said fluid sample.

6. The device according to claim 5, wherein at least a portion of said main channel is a capillary.

7. The device according to claim 5, wherein said agitation means is an impeller.

8. The device according to claim 5, wherein at least one of said side reagent channels comprises at least one capillary valve upstream from said main channel.

9. The device according to claim 5, wherein said main and side reagent areas comprise troughs comprising members of said signal producing system.

10. A disposable assay device for use in analyte detection in a fluid sample, said device comprising:

a housing comprising a top and bottom plate fastened together, wherein said top and bottom fastened together plates comprise;

at least one sample addition port, wherein said sample addition port is in fluid communication with an assay path, wherein said assay path comprises a main channel and one side channel on either side of said main channel, wherein at least a portion of said main channel is a capillary, said main channel comprising in a first direction of fluid flow from said sample addition port;

a main reagent area comprising an impeller;

a main transport channel;

an incubation area;

a waste area, wherein said waste area comprises a means for enhancing fluid flow through said device; and

at least one capillary valve in said main channel at a region upstream from said incubation area; and

said two side channels comprising in a second direction of fluid flow;

a liquid addition port;

a side reagent area comprising an impeller; and

a side reagent transport channel, wherein said side reagent transport channel is in fluid communication with said main transport channel, wherein at least one of said side reagent channels further comprises at least one capillary valve upstream from said main channel;

an optically clear window above said incubation area, and

members of a signal producing system in at least one of said main channel and side reagent channel, wherein said signal producing system produces an optical signal which is related to the presence of analyte in said fluid sample.

11. The device according to claim 10, further comprising a reference region which is not in fluid communication with said assay path.

12. The device according to claim 10, further comprising a priming trough which is not in fluid communication with said assay path.