Devices and methods for molecular diagnostic testing
First Claim
Patent Images
1. An apparatus, comprising:
- a housing;
an amplification module irreversibly coupled within the housing, the amplification module including a flow member and a heater, the flow member defining a reaction volume configured to receive an input sample, the heater coupled to the flow member and configured to convey thermal energy into the reaction volume to amplify a nucleic acid within the input sample to produce an amplified output containing a target amplicon;
a reagent module disposed within the housing, the reagent module containing a reagent;
a detection module defining a detection channel in fluid communication with the reaction volume of the amplification module and the reagent module, the detection module including a detection surface within the detection channel, the detection surface configured to retain the target amplicon when the amplified output flows across the detection surface at a first time, the reagent formulated to cause the production of a signal associated with the target amplicon after the reagent flows across the detection surface at a second time;
a fluid pump disposed within the housing, the fluid pump including a movable member configured to move in a first direction and a second direction different than the first direction, movement of the movable member in the first direction producing a flow of the amplified output within the detection channel, movement of the movable member in the second direction producing a flow of the reagent within the detection channel; and
a control module within the housing, the control module including a processor configured to control movement of the movable member.
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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.
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Citations
27 Claims
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1. An apparatus, comprising:
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a housing; an amplification module irreversibly coupled within the housing, the amplification module including a flow member and a heater, the flow member defining a reaction volume configured to receive an input sample, the heater coupled to the flow member and configured to convey thermal energy into the reaction volume to amplify a nucleic acid within the input sample to produce an amplified output containing a target amplicon; a reagent module disposed within the housing, the reagent module containing a reagent; a detection module defining a detection channel in fluid communication with the reaction volume of the amplification module and the reagent module, the detection module including a detection surface within the detection channel, the detection surface configured to retain the target amplicon when the amplified output flows across the detection surface at a first time, the reagent formulated to cause the production of a signal associated with the target amplicon after the reagent flows across the detection surface at a second time; a fluid pump disposed within the housing, the fluid pump including a movable member configured to move in a first direction and a second direction different than the first direction, movement of the movable member in the first direction producing a flow of the amplified output within the detection channel, movement of the movable member in the second direction producing a flow of the reagent within the detection channel; and a control module within the housing, the control module including a processor configured to control movement of the movable member. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. An apparatus, comprising:
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a housing; an amplification module fixedly coupled within the housing, the amplification module including a flow member and a heater, the flow member defining a flow path configured to receive an input flow of a sample, the heater coupled to the flow member such that a first heating portion of the heater can produce a first temperature zone within a first portion of the flow path and a second heating portion of the heater can produce a second temperature zone within a second portion of the flow path, the first temperature zone and the second temperature zone spaced apart such that the input flow of the sample within the flow path can be thermally cycled to amplify a nucleic acid within the sample to produce an output flow containing a target amplicon; a detection module defining a detection channel in fluid communication with the flow path of the amplification module, the detection channel in fluid communication with a reagent module containing a reagent formulated to produce a signal indicating a presence of the target amplicon, the detection module including a detection surface within the detection channel, the detection surface configured to retain the target amplicon within the output flow produced by the amplification module; a fluid pump including an electric motor disposed within the housing, the electric motor configured to generate a first force that causes the input flow of the sample within the flow path and a second force that causes a flow of the reagent within the detection channel, the second force in a different direction than the first force; and a control module within the housing, the control module including a processor configured to regulate a power input to the electric motor of the fluid pump to control a rate of the input flow of the sample within the flow channel. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19)
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20. An apparatus, comprising:
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a housing; an amplification module fixedly coupled within the housing, the amplification module including a flow member and a heater, the flow member defining a flow path configured to receive an input flow of a sample, the heater coupled to the flow member and configured to convey thermal energy into the flow path to amplify a nucleic acid within the sample to produce an output flow containing a target amplicon; a detection module defining a detection channel in fluid communication with the flow path of the amplification module, the detection channel in fluid communication with a reagent module containing a reagent formulated to produce a signal indicating a presence of the target amplicon, the detection module including a detection surface within the detection channel, the detection surface configured to retain the target amplicon within the output flow produced by the amplification module; a fluid pump disposed within the housing, the fluid pump including an actuator and a movable member, the actuator configured to generate, within the housing, a first force and a second force, the second force in a different direction than the first force, the first force configured to move the movable member to produce the input flow of the sample within the flow path and the output flow within the detection channel; and a control module within the housing, the control module including a processor configured to regulate a power input to the actuator of the fluid pump to control a rate of the input flow of the sample within the flow channel. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27)
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Specification