Devices and methods for molecular diagnostic testing

• US 9,623,415 B2
• Filed: 12/30/2015
• Issued: 04/18/2017
• Est. Priority Date: 12/31/2014
• Status: Active Grant

• Current Assignee: Visby Medical, Inc.
• Original Assignee: Click Diagnostics, Inc.
• Inventors: Andreyev, Boris, Moravick, Keith E., Ciopyk, Brian, Briones, Victor, Loney, Gregory, de la Zerda, Adam, Ching, Jesus, Kelly, Colin, Chu, Steven, Swenson, David, Huang, Helen
• Primary Examiner(s): Hobbs, Michael
• Assistant Examiner(s): HASSAN, LIBAN M
• Application Number:
  US14/984,573
• Publication Number:
  US 20160186240A1
• Time in Patent Office: 475 Days
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/028 Modular arrangements
• CPC Class Codes: B01L 2200/0647 Handling flowable solids, e.g. microscopic beads, cells, particles
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/0689 Sealing
• 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 2300/0627 Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/0883 Serpentine channels
• CPC Class Codes: B01L 2300/18 Means for temperature control
• CPC Class Codes: B01L 2300/1822 using Peltier elements
• CPC Class Codes: B01L 2300/1844 using fans
• CPC Class Codes: B01L 2400/0457 passive flow or gravitation
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0605 check valves
• CPC Class Codes: B01L 2400/0611 duck bill valves
• CPC Class Codes: B01L 2400/0644 : rotary valves
• 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 3/5029 : using swabs
• CPC Class Codes: B01L 3/527 : for a plurality of reagents
• CPC Class Codes: B01L 7/52 : with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples amplification or hybridisation processes per se C12Q1/68; controlling sequential reactions for synthesis B01J19/0046
• CPC Class Codes: B01L 7/525 : with physical movement of samples between temperature zones

Abstract

A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.

Claims

1. A molecular diagnostic test device, comprising:

a housing;

a sample preparation module including a sample input module and a filter assembly disposed within the housing, the sample input module including an inlet port and an outlet port, the inlet port configured to receive an input sample;

a sample actuator operatively coupled to the sample input module, the sample actuator configured to apply a force to the sample input module to convey the input sample from the outlet port through the filter assembly when the sample actuator is moved from a first position to a second position, the sample actuator including a tab configured to irreversibly engage a portion of the housing when the sample actuator is moved to the second position to maintain the sample actuator in the second position;

an amplification module configured to receive the input sample from the sample preparation module, the amplification module defining a reaction volume and including a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample; and

a detection module defining a detection channel configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample,

wherein the amplification module, the sample preparation module, and the detection module are integrated within the housing.

2. The molecular diagnostic test device of claim 1, wherein the signal is a non-fluorescent signal.

3. The molecular diagnostic test device of claim 1, wherein:

the signal is a visible signal characterized by a color associated with the presence of the target amplicon; and

the detection module includes a detection surface from which the visible signal is produced, the detection surface visible via a detection opening defined by the housing.

4. The molecular diagnostic test device of claim 1, wherein the signal is a visible signal characterized by a color associated with the presence of the target amplicon, the reagent formulated such that the visible signal remains present for at least about 30 minutes.

5. The molecular diagnostic test device of claim 1, further comprising:

a power source disposed within the housing and configured to supply power to the amplification module, the power source including a DC battery having a nominal voltage of 9V, the power source having a capacity of less than about 1200 mAh.

6. The molecular diagnostic test device of claim 1, wherein the sample actuator is in a fixed position relative to at least one of the amplification module or the detection module when the sample actuator is in the second position.

7. The molecular diagnostic test device of claim 1, wherein the sample actuator is a non-electronic actuator.

8. The molecular diagnostic test device of claim 1, wherein the molecular diagnostic test device is configured for one and only one use and is disposable.

9. A method of detecting a target amplicon using a disposable molecular diagnostic test device, comprising:

conveying a sample into a sample preparation module, the sample preparation module including a sample input module and a filter assembly within a housing of the disposable molecular diagnostic test device, the sample being conveyed via an input port of the same input module;

moving a sample actuator operably coupled to the sample input module from a first position to a second position to actuate the sample input module to convey the sample from an outlet port of the sample input module and through a filter assembly, a tab of the sample actuator irreversibly engaging a portion of the housing to maintain the sample actuator in the second position;

actuating the molecular diagnostic test device to;

convey the sample from the sample preparation module to an amplification module, the amplification module within the housing of the disposable molecular diagnostic test device, the amplification module defining a reaction volume and including a heater;

perform, within the reaction volume of the amplification module, a polymerase chain reaction (PCR) on the sample; and

convey into a detecting channel defined by a detection module each of A) the sample from the amplification module and B) a reagent formulated to produce a visible signal characterized by a color that indicates a presence of a target amplicon within the sample, the detection module including a detection surface configured to retain the target amplicon to produce the visible signal from the detection surface; and

viewing, via a detection opening defined by the housing, the visible signal from the detection surface; and

discarding, after the viewing, the disposable molecular test device.

10. The method of claim 9, wherein the discarding includes placing the disposable molecular test device in a waste receptacle after a single use.

11. The method of claim 9, wherein the discarding includes placing the disposable molecular test device in a waste receptacle after a single use of the disposable molecular test device and while the sample preparation module and the amplification module are within the housing.

12. The method of claim 9, wherein the detection opening is defined by an outer surface of the housing, the outer surface of the housing including an indicator characterized by the color.

13. The method of claim 9, wherein the detection opening is defined by an outer surface of the housing, the outer surface of the housing including a mask portion surrounding at least a portion of the detection opening, the mask portion including an indicator characterized by the color.

14. The method of claim 9, wherein the actuating the molecular diagnostic test device includes moving a reagent actuator such that a first portion of the reagent actuator exerts a puncture force on a reagent container within the housing and a second portion of the reagent actuator engages a switch to actuate the molecular diagnostic test device.

15. The method of claim 9, wherein the visible signal is produced from the detection surface in less than about 25 minutes after the actuating the molecular diagnostic test device.

16. The method of claim 9, wherein:

the detection surface is a first detection surface that includes a first hybridization probe specific to the target amplicon;

the detection module includes a second detection surface, the second detection surface being visible via the detection opening of the housing, the second detection surface including a second hybridization probe specific to a control; and

the viewing the visible signal includes viewing the visible signal from the first detection surface and the second detection surface.

17. The method of claim 9, wherein:

the sample actuator is a non-electronic actuator.