Assay Cartridges and Methods of Using the Same

• US 20120190589A1
• Filed: 03/30/2012
• Published: 07/26/2012
• 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, Glezer, Eli N., Kumar, Sudeep, Lawrence, Noel, Page, Kenneth, Sigal, George, West, Sharon
• Granted Patent: US 12,013,332 B2
• Time in Patent Office: Days
• US Class Current: 506/39
• 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, a sample indicator window and an optical path from a reflecting surface to said indicator window, wherein said reflecting surface reflects a sample level in said sample chamber to said indicator window.

2. The assay cartridge of claim 1 wherein said sample indicator window comprises an indicating feature.

3. The assay cartridge of claim 2 wherein said indicating feature is an indicating line that indicates a fluid level within said sample chamber, wherein said level is selected from the group consisting of a sample minimum, a sample maximum, a target level and a combination thereof.

4. The assay cartridge of claim 2 wherein said indicating feature is a boundary of said indicator window.

5. The assay cartridge of claim 1 wherein said reflecting surface is a mirrored surface.

6. The assay cartridge of claim 1 wherein said cartridge comprises a cartridge body and said reflecting surface is provided by total internal reflection at an angled surface in said cartridge body.

7. The assay cartridge of claim 6 wherein said angled surface is configured such that an angle of incidence along said optical path is greater than a critical angle for total internal reflection at said reflecting surface.

8. The assay cartridge of claim 7 wherein said angled surface is provided by a surface of a cavity within said cartridge body such that light traveling through said cartridge body along said optical path intersects an air-body interface at said cavity surface and is reflected along said optical path to said indicator window.

9. The assay cartridge of claim 1 wherein said cartridge comprises a cartridge top, a cartridge bottom and a cover layer mated to said cartridge bottom and said optical path is provided by said cartridge top.

10. The assay cartridge of claim 1 wherein said sample chamber is connected to an overflow chamber via a sample overflow conduit.

11. The assay cartridge of claim 10 wherein said overflow chamber is connected to a sample vent port via a vent conduit.

12. The assay cartridge of claim 11 wherein said vent conduit is positioned at or near the top of said overflow chamber.

13. The assay cartridge of claim 1 wherein said sample chamber further comprises a sample introduction port comprising a sealable closure including a sealing/capping mechanism comprising (a) a flexible hinge;

(b) a latching mechanism; and

(c) a retention component comprising a retention ring or tab.

14. The assay cartridge of claim 13 wherein said sealing/capping mechanism is a modular detachable insert comprising a cap for sealing said sample chamber.

15-120. -120. (canceled)