System for portable and easy-to-use detection of analytes with mobile computing device

• US 9,789,483 B2
• Filed: 03/11/2014
• Issued: 10/17/2017
• 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): SIEFKE, SAMUEL P
• Application Number:
  US14/205,146
• Publication Number:
  US 20140336083A1
• Time in Patent Office: 1,316 Days
• 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

This system takes in raw cellular material collected using a provided swab, blood collection device, urine collection device, or other sample collection device and transforms that biological material into a digital result, identifying the presence, absence and/or quantity of nucleic acids, proteins, and/or other molecules of interest.

Claims

1. A system for identifying the presence, absence, and/or quantity of a molecule of interest in a sample, comprising:

a reader; and

a cartridge that fits into the reader, the cartridge configured to accept a sample collection device that fits into the cartridge,

wherein the cartridge comprises;

a first reservoir for storing a liquid, wherein a mixture comprising the liquid and the sample is formed in the first reservoir when the sample collected by the sample collection device is inserted into the first reservoir, and wherein the mixture further comprises a plurality of magnetic particle complexes;

a second reservoir for storing a chemical substrate;

an analysis channel comprising an electrochemical sensor; and

valve-actuating elements for transferring the mixture from the reservoir directly into the analysis channel and the chemical substrate from the second reservoir directly into the analysis channel, wherein the mixture localized over the electrochemical sensor reacts with the chemical substrate at the electrochemical sensor in the analysis channel for detection by the electrochemical sensor, and

wherein the reader comprises a permanent magnet adjacent to the analysis channel when the cartridge fits into the reader such that the plurality of magnetic particle complexes can be localized in the analysis channel at the electrochemical sensor within a magnetic field generated by the permanent magnet.

2. The system of claim 1, wherein each of the plurality of magnetic particle complexes comprises a magnetic particle.

3. The system of claim 1, wherein the permanent magnet comprises more than one magnet.

4. The system of claim 1, wherein the electrochemical sensor releases a flow of electrons in a quantity proportional to a number of the plurality of magnetic particle complexes localized at the electrochemical sensor in the analysis channel in response to reactions between the mixture and the chemical substrate.

5. The system of claim 1, wherein the molecule of interest comprises one or more of a nucleic acid, protein, or small molecule.

6. The system of claim 1, wherein the reaction detected by the electrochemical sensor is proportional to a number of signaling enzymes of the plurality of magnetic particle complexes localized over the electrochemical sensor in the analysis channel.

7. The system of claim 6, wherein the second reservoir is configured to store a liquid comprising the chemical substrate, and wherein the chemical substrate is configured to react with the signaling enzymes.

8. The system of claim 1, wherein the cartridge comprises a slot to allow for the permanent magnet to slide into place underneath the electrochemical sensor.

9. The system of claim 1, wherein the reader is configured to send or receive, or both, signals to a mobile device indicative of a test result.

10. The system of claim 9, further comprising an application stored on the mobile device, the application configured to cause the mobile device to display the test result.

11. The system of claim 1, wherein the reader is configured to send or receive, or both, signals to a mobile device indicative of a test protocol.

12. The system of claim 1, wherein the cartridge further comprises a first valve between the first reservoir and the analysis channel and a second valve between the second reservoir and the analysis channel.

13. The system of claim 12, wherein the first and second valves are phase change valves.

14. The system of claim 13, wherein the valve-actuating elements comprise vias configured to heat the phase change valves to transfer the mixture and the chemical substrate to the analysis channel.

15. The system of claim 1, further comprising a sonicator configured to direct energy into the mixture in the first reservoir.

16. The system of claim 1, further comprising a third reservoir for storing a wash solution, wherein one of the valve-actuating elements facilitates transfer of the wash solution to the analysis channel.

17. The system of claim 1, wherein the system further comprises the sample collection device, the sample collection device configured to collect the sample from blood, urine, or saliva.