Devices and methods for molecular diagnostic testing
First Claim
1. A method of detecting a target nucleic acid molecule using a molecular diagnostic test device, comprising:
- conveying a biological sample from a sample input volume defined by a sample input module towards an amplification module to rehydrate and mix a solid control organism within the sample input volume with the biological sample to form an input solution, the solid control organism being nonpathogenic to humans, the sample input module and the amplification module each coupled within a housing of the molecular diagnostic test device, the amplification module defining a reaction volume and including a heater;
heating the input solution within at least a portion of the reaction volume via the heater to amplify a control nucleic acid within the control organism and the target nucleic acid molecule within the biological sample thereby producing an output solution containing a target amplicon and a control amplicon; and
reacting within a detection module within the housing each of A) the output solution and B) a reagent to produce a first signal indicating a presence of the target amplicon and a second signal indicating a presence of the control amplicon.
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Accused Products
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
16 Claims
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1. A method of detecting a target nucleic acid molecule using a molecular diagnostic test device, comprising:
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conveying a biological sample from a sample input volume defined by a sample input module towards an amplification module to rehydrate and mix a solid control organism within the sample input volume with the biological sample to form an input solution, the solid control organism being nonpathogenic to humans, the sample input module and the amplification module each coupled within a housing of the molecular diagnostic test device, the amplification module defining a reaction volume and including a heater; heating the input solution within at least a portion of the reaction volume via the heater to amplify a control nucleic acid within the control organism and the target nucleic acid molecule within the biological sample thereby producing an output solution containing a target amplicon and a control amplicon; and reacting within a detection module within the housing each of A) the output solution and B) a reagent to produce a first signal indicating a presence of the target amplicon and a second signal indicating a presence of the control amplicon. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method of detecting a target nucleic acid molecule using a molecular diagnostic test device, comprising:
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conveying a biological sample into a sample preparation module within the molecular diagnostic test device; and actuating the molecular diagnostic test device to cause the molecular diagnostic test device to; convey the biological sample from a sample input volume defined by the sample preparation module towards an amplification module such that a solid control organism within the sample input volume is mixed with the biological sample to form an input solution, the solid control organism being nonpathogenic to humans, the amplification module defining a reaction volume and including a heater; heat the input solution within the reaction volume via the heater through at least 30 thermal cycles to amplify a control nucleic acid within the control organism and the target nucleic acid molecule within the biological sample thereby producing an output solution containing a target amplicon and a control amplicon; and react within a detection module within the molecular diagnostic test device each of A) the output solution and B) a reagent to produce a first signal indicating a presence of the target amplicon and a second signal indicating a presence of the control amplicon. - View Dependent Claims (11, 12, 13, 14, 15, 16)
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Specification