Devices and methods for molecular diagnostic testing
First Claim
Patent Images
1. An apparatus, comprising:
- a housing having an outer surface defining a detection window;
a sample input module enclosed by the housing, the sample input module defining a sample input volume that receives an input sample;
a solid control organism within the sample input volume, the solid control organism being nonpathogenic to humans and being rehydrated and mixed with the input sample when the input sample is conveyed from the sample input volume;
an amplification module fixedly coupled within the housing and configured to receive the input sample, the amplification module defining a reaction volume and including a heater, the amplification module configured to amplify a control nucleic acid within the control organism to produce a control amplicon along with amplification of a nucleic acid within the input sample to produce a target amplicon;
a reagent module within the housing, the reagent module containing a reagent formulated to produce a first visible signal indicating a presence of the target amplicon and a second visible signal indicating a presence of the control amplicon; and
a detection module that receives an output produced by the amplification module including the target amplicon and the control amplicon, the detection module including a first detection surface and a second detection surface, the first detection surface configured to interact with the target amplicon such that when the reagent is conveyed from the reagent module to the detection surface, the first visible signal is produced from the first detection surface, the second detection surface configured to interact with the control amplicon such that when the detection module contains the reagent the second visible signal is produced from the second detection surface, the detection module positioned such that the first visible signal and the second visible signal are viewable via the detection window of the housing.
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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.
257 Citations
31 Claims
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1. An apparatus, comprising:
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a housing having an outer surface defining a detection window; a sample input module enclosed by the housing, the sample input module defining a sample input volume that receives an input sample; a solid control organism within the sample input volume, the solid control organism being nonpathogenic to humans and being rehydrated and mixed with the input sample when the input sample is conveyed from the sample input volume; an amplification module fixedly coupled within the housing and configured to receive the input sample, the amplification module defining a reaction volume and including a heater, the amplification module configured to amplify a control nucleic acid within the control organism to produce a control amplicon along with amplification of a nucleic acid within the input sample to produce a target amplicon; a reagent module within the housing, the reagent module containing a reagent formulated to produce a first visible signal indicating a presence of the target amplicon and a second visible signal indicating a presence of the control amplicon; and a detection module that receives an output produced by the amplification module including the target amplicon and the control amplicon, the detection module including a first detection surface and a second detection surface, the first detection surface configured to interact with the target amplicon such that when the reagent is conveyed from the reagent module to the detection surface, the first visible signal is produced from the first detection surface, the second detection surface configured to interact with the control amplicon such that when the detection module contains the reagent the second visible signal is produced from the second detection surface, the detection module positioned such that the first visible signal and the second visible signal are viewable via the detection window of the housing. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. An apparatus, comprising:
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a housing having an outer surface defining a detection window; a solid control organism stored within a flow path enclosed by the housing, the solid control organism being nonpathogenic to humans and being rehydrated and mixed with an input sample when the input sample is conveyed through the flow path towards an amplification module; the amplification module fixedly coupled within the housing and configured to receive the input sample, the amplification module defining a reaction volume and including a heater such that the amplification module can amplify a nucleic acid within the input sample and a control nucleic acid within the control organism to produce an output containing a target amplicon and a control amplicon; a detection module disposed within the housing, the detection module including a first detection surface and a second detection surface, the detection module defining a detection channel through which the output produced by the amplification module flows across the first detection surface and the second detection surface, the first detection surface configured to interact with the target amplicon such that when a reagent formulated to produce a first visible signal indicating a presence of the target amplicon flows across the first detection surface, the first visible signal is produced from the first detection surface, the second detection surface configured to interact with the control amplicon such that when the detection module contains the reagent a second visible signal is produced from the second detection surface, the detection module positioned such that the first detection surface and the second detection surface are visible via the detection window of the housing; and a fluid pump disposed within the housing, the fluid pump configured to generate a first force that causes a flow of at least one of the input sample or the output produced by the amplification module and a second force that causes a flow of the reagent across the first detection surface. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. An apparatus, comprising:
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a housing defining a detection window; a sample input module enclosed by the housing, the sample input module defining a sample input volume that receives an input sample; a solid control organism within the sample input module, the solid control organism being nonpathogenic to humans and being rehydrated by and mixed with the input sample to form an input solution when the input sample is conveyed from the sample input volume; an amplification module fixedly coupled within the housing and configured to receive the input solution including the control organism from the sample input module, the amplification module including a first flow member and a heater, the first flow member defining a reaction volume, the heater coupled to the first flow member such that the amplification module can amplify a target nucleic acid within the input solution to produce a target amplicon and a control nucleic acid within the control organism to produce a control amplicon; and a detection module enclosed by the housing and configured to receive an output produced by the amplification module including the target amplicon and the control amplicon, the detection module including a second flow member including a first detection surface configured to capture the target amplicon such that when a reagent formulated to produce a first visible signal indicating a presence of the target amplicon is present at the first detection surface, the first visible signal is produced, the second flow member including a second detection surface configured to capture the control amplicon such that when the reagent is present at the second detection surface, a second visible signal is produced, the first detection surface and the second detection surface each being visible via the detection window of the housing. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31)
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Specification