Devices and methods for molecular diagnostic testing
First Claim
Patent Images
1. An apparatus, comprising:
- a housing;
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 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 target nucleic acid within the input sample to produce a target amplicon;
a reagent formulated to produce a first signal indicating a presence of the target amplicon and a second 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 detection module contains the reagent the first 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 signal is produced from the second detection surface.
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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.
278 Citations
23 Claims
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1. An apparatus, comprising:
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a housing; 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 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 target nucleic acid within the input sample to produce a target amplicon; a reagent formulated to produce a first signal indicating a presence of the target amplicon and a second 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 detection module contains the reagent the first 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 signal is produced from the second detection surface. - 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; 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 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 target nucleic acid within the input sample to produce a target amplicon; a reagent formulated to cause a first signal indicating a presence of the target amplicon and a second signal indicating a presence of the control amplicon to be produced; 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 within the detection module the first signal is produced from the first detection surface, the second detection surface configured to interact with the control amplicon such that when the reagent is within the detection module the second signal is produced from the second detection surface. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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Specification