Systems and methods for detection and quantification of analytes

• US 9,207,244 B2
• Filed: 01/16/2015
• Issued: 12/08/2015
• Est. Priority Date: 03/11/2013
• Status: Active Grant

• Current Assignee: Cue Health Inc.
• Original Assignee: Cue, Inc. (Cue Health Inc.)
• Inventors: Khattak, Ayub, Sever, Clinton
• Primary Examiner(s): WHITE, DENNIS MICHAEL
• Application Number:
  US14/599,372
• Publication Number:
  US 20150140646A1
• Time in Patent Office: 326 Days
• US Class Current: 1/1
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/028 Modular arrangements
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/0668 Trapping microscopic beads
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/087 Ergonomic aspects
• 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 2300/023 Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/025 Displaying results or values with integrated means
• CPC Class Codes: B01L 2300/04 Closures and closing means
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/06 Auxiliary integrated devices, integrated components
• CPC Class Codes: B01L 2300/0627 Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0838 : Capillaries
• CPC Class Codes: B01L 2300/0864 : comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/0867 : Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/087 : Multiple sequential chambers
• CPC Class Codes: B01L 2300/12 : Specific details about materials
• CPC Class Codes: B01L 2300/161 : Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 2300/1827 : using resistive heater
• CPC Class Codes: B01L 2400/0406 : capillary forces
• CPC Class Codes: B01L 2400/0487 : fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0677 : phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
• CPC Class Codes: B01L 2400/0683 : mechanically breaking a wall or membrane within a channel or chamber
• 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 3/502738 : characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: B01L 3/5029 : using swabs
• CPC Class Codes: B05D 2518/00 : Other type of polymers
• CPC Class Codes: B05D 3/002 : Pretreatement
• CPC Class Codes: C12Q 1/6825 : Nucleic acid detection involving sensors
• CPC Class Codes: F16K 2099/0084 : Chemistry or biology, e.g. "lab-on-a-chip" technology
• CPC Class Codes: F16K 99/0032 : using phase transition or influencing viscosity
• CPC Class Codes: F16K 99/0036 : operated by temperature variations
• CPC Class Codes: G01N 1/02 : Devices for withdrawing samples sampling of foundation soil E02D1/04; collecting or conveying radioactive samples G01T7/00, e.g. G01T7/02, G01T7/08
• CPC Class Codes: G01N 2001/027 : field kits / quick test kits
• CPC Class Codes: G01N 2001/028 : Sampling from a surface, swabbing, vaporising
• CPC Class Codes: G01N 2035/00277 : Special precautions to avoid contamination (e.g. enclosures, glove- boxes, sealed sample carriers, disposal of contaminated material)
• CPC Class Codes: G01N 2035/00564 : Handling or washing solid phase elements, e.g. beads
• CPC Class Codes: G01N 21/78 : producing a change of colour
• CPC Class Codes: G01N 2458/30 : Electrochemically active labels
• CPC Class Codes: G01N 27/28 : Electrolytic cell components
• CPC Class Codes: G01N 27/3271 : Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 27/3272 : Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 : Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 33/54306 : Solid-phase reaction mechanisms
• CPC Class Codes: G01N 33/54326 : Magnetic particles
• CPC Class Codes: G01N 33/54333 : Modification of conditions of immunological binding reaction, e.g. use of more than one type of particle, use of chemical agents to improve binding, choice of incubation time or application of magnetic field during binding reaction
• CPC Class Codes: G01N 33/54366 : Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54373 : involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
• CPC Class Codes: G01N 33/5438 : Electrodes
• CPC Class Codes: G01N 33/581 : with enzyme label (including co-enzymes, co-factors, enzyme inhibitors or substrates)
• CPC Class Codes: G01N 35/00029 : provided with flat sample substrates, e.g. slides G01N35/028 takes precedence
• CPC Class Codes: G01N 35/0098 : involving analyte bound to insoluble magnetic carrier, e.g. using magnetic separation magnetic particles used in immunoassays G01N33/54326; magnetic separation in general B03C
• CPC Class Codes: G01N 35/08 : using a stream of discrete samples flowing along a tube system, e.g. flow injection analysis
• CPC Class Codes: G01N 35/1095 : for supplying the samples to flow-through analysers for a specific analyser see relevant groups, e.g. under G01N15/00, G01N21/00, G01N27/00, G01N30/00, H01J49/00
• CPC Class Codes: H04M 1/72409 : by interfacing with external accessories hands-free H04M1/60
• CPC Class Codes: H04M 1/72412 : using two-way short-range wireless interfaces
• CPC Class Codes: Y10T 137/1797 : Heat destructible or fusible

Abstract

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. In some embodiments, the reader component communicates with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

Claims

1. An analyte detection kit configured to securely store, during and after analyte detection, a collected sample and reagents needed to detect an analyte within the collected sample, the analyte detection kit comprising:

a sample collection device; and

a detection unit comprising;

an aperture at a surface of the detection unit;

a reservoir of fluid located within the detection unit;

an analysis channel within the detection unit, the analysis channel configured to receive fluid comprising said reagents from the reservoir;

a sensor disposed within the analysis channel, the sensor configured to generate a signal indicative of at least one of presence, absence, and quantity of the analyte; and

an input tunnel extending from the aperture to an entryway of the reservoir;

wherein the input tunnel is configured to securely and irreversibly receive the sample collection device, and when the input tunnel has securely received the sample collection device, the sample collection device extends from the reservoir of fluid to at least the aperture; and

wherein the input tunnel comprises;

an elongated portion having a diameter that restricts lateral movement of the sample collection device within the input tunnel;

one or more locking features that restrict at least one of axial and longitudinal movement of the sample collection device within the input tunnel; and

a sealing zone configured to achieve a liquid-tight seal between the input tunnel and the sample collection device at a location between the aperture and the reservoir.

2. The analyte detection kit of claim 1, further comprising a selectively breakable membrane covering the entryway of the reservoir, wherein the selectively breakable membrane prevents fluid from flowing out of the reservoir through the entryway of the reservoir.

3. The analyte detection kit of claim 2, wherein the selectively breakable membrane is made of at least one of polyurethane, polysilicone and polybutadiene, nitrile, parafilm, latex, foil, and polyethylene terephthalate.

4. The analyte detection kit of claim 2, wherein the selectively breakable membrane is single-walled or double-walled.

5. The analyte detection kit of claim 2, wherein one or more of the reagents are configured to be carried into the reservoir when the selectively breakable membrane is broken by insertion of the sample collection device.

6. The analyte detection kit of claim 2, wherein the sealing zone of the input tunnel achieves the liquid-tight seal between the input tunnel and the sample collection device at, or substantially at, an instant the sample collection device pushes the selectively breakable membrane to its rupture point.

7. The analyte detection kit of claim 1, wherein the sealing zone of the input tunnel comprises a portion having a narrowed diameter.

8. The analyte detection kit of claim 1, wherein the one or more locking features of the input tunnel comprise at least one of one or more positive grooves radially placed in the input tunnel, one or more negative grooves radially placed in the input tunnel, and one or more non-radial engagement features.

9. The analyte detection kit of claim 1, wherein the input tunnel further comprises a vent for displacement of air within the input tunnel.

10. The analyte detection kit of claim 1, wherein the sample collection device is configured to collect a sample from at least one of a body part and an environment.

11. The analyte detection kit of claim 1, wherein the sample collection device comprises:

a shaft; and

a collection head coupled to the shaft.

12. The analyte detection kit of claim 11, wherein the collection head comprises:

a collection head tip; and

a collection area formed of a capillary tube within the collection head.

13. The analyte detection kit of claim 11, wherein the collection head is configured to be able to break the selectively breakable membrane.

14. The analyte detection kit of claim 12, wherein the collection head tip is selected from the group of:

blunt with no sharp edges, rounded, or substantially rounded.

15. The analyte detection kit of claim 1, wherein the sample collection device comprises:

a collection portion for collecting and storing a sample;

a sealing portion for facilitating the formation of the liquid-tight seal between the input tunnel and the sample collection device;

a locking portion for facilitating a fixed engagement between the sample collection device and the input tunnel; and

a handle portion for a user to grasp the sample collection device.

16. The analyte detection kit of claim 15, wherein the locking portion of the sample collection device is configured such that upon insertion of the sample collection device into the input tunnel, the sample collection device is mated irreversibly and immovably with the input tunnel.

17. The analyte detection kit of claim 15, wherein the locking portion of the sample collection device comprises at least one of one or more negative grooves radially placed on the sample collection device, one or more positive grooves radially placed on the sample collection device, and one or more non-radial engagement features.

18. The analyte detection kit of claim 15, wherein engagement features on the locking portion of the sample collection device and the input tunnel are configured such that one or more of the engagement features are reversibly compressed or retracted when the sample collection device is being inserted into the input tunnel, and are returned to their initial positions when the sample collection device and the input tunnel are fully engaged.

19. The analyte detection kit of claim 15, wherein the sealing portion comprises a gasket.

20. The analyte detection kit of claim 15, wherein the handle portion is removable.

21. An analyte detection kit configured to securely store, during and after analyte detection, a collected sample and reagents needed to detect an analyte within the collected sample, the analyte detection kit comprising:

a sample collection device; and

a detection unit comprising;

an aperture at a surface of the detection unit;

a reservoir of fluid located within the detection unit; and

an input tunnel extending from the aperture to an entryway of the reservoir;

wherein the input tunnel is configured to securely and irreversibly receive the sample collection device, and when the input tunnel has securely received the sample collection device, the sample collection device extends from the reservoir of fluid comprising said reagents to at least the aperture; and

wherein the input tunnel comprises;

an elongated portion having a diameter that restricts lateral movement of the sample collection device within the input tunnel;

one or more locking features that restrict at least one of axial and longitudinal movement of the sample collection device within the input tunnel such that the sample collection device is irreversibly mated within the input tunnel; and

a sealing zone configured to achieve a liquid-tight seal between the input tunnel and the sample collection device at a location between the aperture and the reservoir.

22. The analyte detection kit of claim 21, wherein the one or more locking features of the input tunnel comprise at least one of one or more positive grooves radially placed in the input tunnel, one or more negative grooves radially placed in the input tunnel, and one or more non-radial engagement features.

23. The analyte detection kit of claim 21, wherein the sample collection device is configured to collect a sample from at least one of a body part and an environment.

24. The analyte detection kit of claim 21, wherein the sample collection device comprises:

a shaft; and

a collection head coupled to the shaft.

25. The analyte detection kit of claim 24, wherein the collection head comprises:

a collection head tip; and

a collection area formed of a capillary tube within the collection head.

26. The analyte detection kit of claim 21, wherein the sample collection device comprises:

a collection portion for collecting and storing a sample;

a sealing portion for facilitating the formation of the liquid-tight seal between the input tunnel and the sample collection device;

a locking portion for facilitating a fixed engagement between the sample collection device and the input tunnel; and

a handle portion for a user to grasp the sample collection device.

27. The analyte detection kit of claim 26, wherein the locking portion of the sample collection device is configured such that upon insertion of the sample collection device into the input tunnel, the sample collection device is mated irreversibly and immovably with the input tunnel.

28. The analyte detection kit of claim 26, wherein the locking portion of the sample collection device includes at least one of one or more negative grooves radially placed on the sample collection device, one or more positive grooves radially placed on the sample collection device, and one or more non-radial engagement features.

29. The analyte detection kit of claim 26, wherein engagement features on the locking portion of the sample collection device and the input tunnel are configured such that one or more of the engagement features are reversibly compressed or retracted when the sample collection device is being inserted into the input tunnel, and are returned to their initial positions when the sample collection device and the input tunnel are fully engaged.

30. The analyte detection kit of claim 26, wherein the sealing portion comprises a gasket.