Assay cartridges and method of using the same

• US 10,184,884 B2
• Filed: 12/03/2010
• Issued: 01/22/2019
• Est. Priority Date: 12/07/2009
• Status: Active Grant

• Current Assignee: Meso Scale Technologies, LLC
• Original Assignee: Meso Scale Technologies, LLC
• Inventors: Anderson, Nicholas, Debad, Jeffery, Glezar, Eli N., Kumar, Sudeep, Lawrence, Noel, Page, Kenneth, Sigal, George, West, Sharon
• Primary Examiner(s): Kwak, Dean
• Application Number:
  US12/959,952
• Publication Number:
  US 20110201099A1
• Time in Patent Office: 2,972 Days
• Field of Search: 422554, 422 8205, 422400
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2200/147 Employing temperature sensors
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/024 Storing results with means integrated into the container
• CPC Class Codes: B01L 2300/027 Digital display, e.g. LCD, LED
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0809 rectangular shaped
• CPC Class Codes: B01L 2300/0874 Three dimensional network
• CPC Class Codes: B01L 2300/0877 Flow chambers
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2300/126 Paper
• CPC Class Codes: B01L 2300/161 : Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 2400/0487 : fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0672 : Swellable plugs
• CPC Class Codes: B01L 2400/0683 : mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 2400/0688 : surface tension valves, capillary stop, capillary break
• 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 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502723 : characterised by venting arrangements
• 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: B01L 3/502784 : specially adapted for droplet or plug flow, e.g. digital microfluidics automatic analysis using a stream of discrete samples in a tube system G01N35/08
• CPC Class Codes: B01L 7/00 : Heating or cooling apparatus autoclaves B01J3/04; Heat insulating devices
• CPC Class Codes: B01L 9/527 : for microfluidic devices, e.g. used for lab-on-a-chip
• CPC Class Codes: B29C 48/02 : Small extruding apparatus, e.g. handheld, toy or laboratory extruders
• CPC Class Codes: B29C 48/154 : Coating solid articles, i.e. non-hollow articles
• CPC Class Codes: B29C 48/266 : Means for allowing relative movements between the apparatus parts, e.g. for twisting the extruded article or for moving the die along a surface to be coated
• CPC Class Codes: B29C 48/34 : Cross-head annular extrusion nozzles, i.e. for simultaneously receiving moulding material and the preform to be coated
• CPC Class Codes: B29C 48/79 : of preformed parts or layers
• CPC Class Codes: B29C 48/86 : at the nozzle zone
• CPC Class Codes: B29C 48/875 : for achieving a non-uniform temperature distribution, e.g. using barrels having both cooling and heating zones
• CPC Class Codes: B29C 70/504 : using rollers or pressure bands for corrugating B29C53/22
• CPC Class Codes: B29C 70/521 : and impregnating the reinforcement before the die
• CPC Class Codes: B29C 70/526 : Pultrusion dies, e.g. dies with moving or rotating parts B29C70/523 takes precedence
• CPC Class Codes: B29C 70/682 : Preformed parts characterised by their structure, e.g. form
• CPC Class Codes: B29C 70/747 : Applying material, e.g. foam, only in a limited number of places or in a pattern, e.g. to create a decorative effect
• CPC Class Codes: B29C 70/78 : Moulding material on one side only of the preformed part
• CPC Class Codes: B29C 70/86 : Incorporated in coherent impregnated reinforcing layers, e.g. by winding
• CPC Class Codes: G01F 23/02 : by gauge glasses or other apparatus involving a window or transparent tube for directly observing the level to be measured or the level of a liquid column in free communication with the main body of the liquid
• CPC Class Codes: G01F 23/292 : Light , e.g. infrared or ultraviolet
• CPC Class Codes: G01N 1/10 : in the liquid or fluent state burettes, pipettes B01L3/02; sampling of ground water E02D1/06; metering by volume of fluids or fluent solid material G01F11/00, G01F13/00
• CPC Class Codes: G01N 2021/0346 : Capillary cells; Microcells
• CPC Class Codes: G01N 2021/054 : Bubble trap; Debubbling
• CPC Class Codes: G01N 21/03 : Cuvette constructions
• CPC Class Codes: G01N 21/0303 : Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment G01N21/031 - G01N21/15 take precedence
• CPC Class Codes: G01N 21/05 : Flow-through cuvettes G01N21/09 takes precedence; handling fluid samples G01N1/10
• CPC Class Codes: G01N 21/13 : Moving of cuvettes or solid samples to or from the investigating station handling materials for automatic analysis G01N35/00
• CPC Class Codes: G01N 21/253 : for batch operation, i.e. multisample apparatus analytical automats G01N35/00
• CPC Class Codes: G01N 21/6452 : Individual samples arranged in a regular 2D-array, e.g. multiwell plates
• CPC Class Codes: G01N 21/69 : specially adapted for fluids , e.g. molten metal
• CPC Class Codes: G01N 21/76 : Chemiluminescence; Bioluminescence
• CPC Class Codes: Y10T 137/0396 : Involving pressure control
• CPC Class Codes: Y10T 137/8593 : Systems

Abstract

Assay cartridges are described that have a detection chamber, preferably having integrated electrodes, and other fluidic components which may include sample chambers, waste chambers, conduits, vents, bubble traps, reagent chambers, dry reagent pill zones and the like. In certain embodiments, these cartridges are adapted to receive and analyze a sample collected on an applicator stick. Also described are kits including such cartridges and a cartridge reader configured to analyze an assay conducted using an assay cartridge.

Claims

1. An assay cartridge comprising:

a sample chamber connected to a collection component comprising a collection chamber and a sensing chamber, wherein the assay cartridge comprises a top longitudinal plane and an opposite bottom,

wherein a collection conduit connects the sample chamber to the collection chamber proximate to a top of said collection chamber, and

an output conduit is connected proximate to a bottom of said collection chamber,

wherein a sensing conduit fluidly connects the collection chamber to the sensing chamber, wherein said sensing conduit comprises a tube that connects near the top of the collection chamber and extends into the collection chamber toward the bottom of said collection chamber and terminates before reaching the bottom of said collection chamber, wherein at least a portion of the tube extends in a lateral direction wherein said sensing chamber also connects to a sensing chamber vent, and

wherein a sample comprising at least a liquid is capable of being drawn from the sample chamber into the collection chamber through the collection conduit and a portion of the sample is capable of being drawn to the sensing chamber through the sensing conduit when the sample chamber is fluidly connected to a vent and the sensing chamber vent is exposed to a vacuum, and

wherein a portion of the collection conduit, a portion of the sending conduit, a portion of the sensing chamber vent and a portion of the output conduit are substantially parallel to each other.

2. The assay cartridge of claim 1 wherein said collection chamber further comprises a baffle positioned between said collection and sensing conduits.

3. The assay cartridge of claim 2, wherein the approximate ratio of the dimensional measurements in the assay cartridge of the liquid volume to the air head space volume in the collection chamber is about 1:

2 after liquid has reached a distal end of the sensing conduit.

4. The assay cartridge of claim 3, wherein the liquid volume is about 125 μ

L and the air head space volume is about 250 μ

L.

5. The assay cartridge of claim 1 wherein the cartridge is adapted to have a portion of said liquid in the sensing chamber detected by an optical sensor.

6. The assay cartridge of claim 5 wherein the optical sensor is contained in the cartridge.

7. The assay cartridge of claim 1 further comprising a detection chamber and a distribution conduit interconnected to a plurality of fluid conduits comprising said output conduit, a detection chamber conduit connected to said detection chamber.

8. The assay cartridge of claim 7 wherein said distribution conduit comprises a Z-transition.

9. The assay cartridge of claim 8 wherein said cartridge comprises an air vent and said plurality of fluid conduits include an air vent conduit connected to said air vent, wherein said detection chamber conduit is distal from said air vent conduit.

10. The assay cartridge of claim 9 wherein said cartridge comprises a wash buffer chamber and said plurality of fluid conduits comprise a wash buffer chamber conduit connected to said wash buffer chamber, wherein said wash buffer chamber conduit is proximal to said air vent conduit and distal to said detection chamber conduit.

11. The assay cartridge of claim 1, wherein at least a portion of said sample exits said collection chamber through said output conduit when said output conduit is exposed to a vacuum source and the sensing chamber vent is vented.

12. The assay cartridge of claim 1, wherein at least a portion of said sample exits said collection chamber through said output conduit when said output conduit is vented and the sensing chamber vent is exposed to a positive pressure source.

13. The assay cartridge of claim 1 wherein an optical sensor located on a cartridge reader is adapted to detect the presence of liquid in said sensing chamber.

14. The assay cartridge of claim 1, wherein the approximate ratio of the dimensional measurements in the assay cartridge of the liquid volume to the air head space volume in the collection chamber is about 1:

2 after liquid has reached a distal end of the sensing conduit.

15. An assay cartridge comprising:

a sample chamber connected to a collection component comprising a collection chamber and a sensing chamber, wherein the assay cartridge comprises a top longitudinal plane and an opposite bottom,

wherein a collection conduit connects the sample chamber to the collection chamber proximate to a top of said collection chamber, and

an output conduit is connected proximate to a bottom of said collection chamber;

wherein a sensing conduit fluidly connects the collection chamber to the sensing chamber, wherein said sensing conduit extends near the top of the collection chamber into the collection chamber toward the bottom of said collection chamber and terminates before reaching the bottom of said collection chamber, wherein at least a portion of the sensing conduit extends in a lateral direction wherein said sensing chamber also connects to a sensing chamber vent, and

wherein a sample comprising at least a liquid is capable of being drawn from the sample chamber into the collection chamber through the collection conduit and a portion of the sample is capable of being drawn to the sensing chamber through the sensing conduit when the sample chamber is fluidly connected to a vent and the sensing chamber vent is exposed to a vacuum, and

wherein a portion of the collection conduit, a portion of the sending conduit, a portion of the sensing chamber vent and a portion of the output conduit are substantially parallel to each other.

16. The assay cartridge of claim 15, wherein said collection chamber further comprises a baffle positioned between said collection and sensing conduits.

17. The assay cartridge of claim 15 wherein an optical sensor is adapted to detect the presence of a portion of said liquid in said sensing chamber.

18. The assay cartridge of claim 15, wherein at least a portion of said sample exits said collection chamber through said output conduit when said output conduit is exposed to a vacuum source and the sensing chamber vent is vented.

19. The assay cartridge of claim 15, wherein at least a portion of said sample exits said collection chamber through said output conduit when said output conduit is vented and the sensing chamber vent is exposed to a positive pressure source.