Devices and methods for molecular diagnostic testing
First Claim
1. A method of detecting a target nucleic acid using a stand-alone molecular diagnostic test device without any external instrument, the stand-alone molecular diagnostic test device including an amplification module, a detection module, and a control module, each of the amplification module, the detection module, and the control module integrated within a housing, the method comprising:
- heating a first heating portion of a heater of the amplification module to produce a first temperature zone within a first portion of a reaction volume of the amplification module and a second heating portion of the heater to produce a second temperature zone within a second portion of the reaction volume;
producing a flow of an input sample within the reaction volume such that the input sample is thermally cycled through at least 30 thermal cycles to amplify the target nucleic acid within the input sample to produce an output solution containing a target amplicon;
controlling, via the control module, the flow of the input sample through the reaction volume to produce a flow rate of the input sample of at least 0.2 μ
l/sec;
conveying to the detection module the output solution, the detection module containing a reagent formulated to produce a signal that indicates a presence of the target amplicon within the output solution, the detection module including a detection surface capturing the target amplicon to produce the signal; and
discarding the stand-alone molecular test device after the signal is read.
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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.
249 Citations
21 Claims
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1. A method of detecting a target nucleic acid using a stand-alone molecular diagnostic test device without any external instrument, the stand-alone molecular diagnostic test device including an amplification module, a detection module, and a control module, each of the amplification module, the detection module, and the control module integrated within a housing, the method comprising:
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heating a first heating portion of a heater of the amplification module to produce a first temperature zone within a first portion of a reaction volume of the amplification module and a second heating portion of the heater to produce a second temperature zone within a second portion of the reaction volume; producing a flow of an input sample within the reaction volume such that the input sample is thermally cycled through at least 30 thermal cycles to amplify the target nucleic acid within the input sample to produce an output solution containing a target amplicon; controlling, via the control module, the flow of the input sample through the reaction volume to produce a flow rate of the input sample of at least 0.2 μ
l/sec;conveying to the detection module the output solution, the detection module containing a reagent formulated to produce a signal that indicates a presence of the target amplicon within the output solution, the detection module including a detection surface capturing the target amplicon to produce the signal; and discarding the stand-alone molecular test device after the signal is read. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 13, 14, 15)
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9. A method of detecting a target nucleic acid using a stand-alone molecular diagnostic test device without any external instrument, comprising:
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conveying a biological sample into a sample preparation module within the stand-alone molecular diagnostic test device; and actuating the stand-alone molecular diagnostic test device to cause the stand-alone molecular diagnostic test device to; lyse, within the sample preparation module, the biological sample to produce an input sample; heat a first heating portion of a heater of an amplification module fixedly coupled within the stand-alone molecular diagnostic device to produce a first temperature zone within a first portion of a reaction volume of the amplification module; heat a second heating portion of the heater to produce a second temperature zone within a second portion of the reaction volume; produce a flow of the input sample within the reaction volume such that the input sample flows within the first temperature zone and the second temperature zone through at least 30 cycles to amplify the target nucleic acid within the input sample to produce an output solution containing a target amplicon, the flow of the input sample and the heater being controlled to produce at least 75 μ
l of the output solution in 10 minutes or less;convey to a detection module within the stand-alone molecular diagnostic test device the output solution, the detection module containing a reagent formulated to produce a signal that indicates a presence of the target amplicon within the output solution, the detection module that including a detection surface configured to capture the target amplicon to produce the signal; reading a result associated with the signal; and discarding, after the reading, the stand-alone molecular test device. - View Dependent Claims (10, 11, 12, 16)
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17. A method of detecting a target nucleic acid using a stand-alone molecular diagnostic test device without any external instrument, comprising:
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conveying a biological sample into a sample preparation module within the stand-alone molecular diagnostic test device; and actuating the stand-alone molecular diagnostic test device to cause the stand-alone molecular diagnostic test device to; lyse, within the sample preparation module, the biological sample to produce an input sample; heat a first heating portion of a heater of an amplification module fixedly coupled within the stand-alone molecular diagnostic device to produce a first temperature zone within a first portion of a flow path of the amplification module; heat a second heating portion of the heater to produce a second temperature zone within a second portion of the flow path; produce a flow of the input sample within the flow path such that the input sample flows between the first temperature zone and the second temperature zone at a flow rate of at least 0.1 μ
l/sec through at least 30 cycles to amplify the target nucleic acid within the input sample to produce an output solution containing a target amplicon; andconvey to a detection module within the stand-alone molecular diagnostic test device the output solution, the detection module containing a reagent formulated to produce a signal that indicates a presence of the target amplicon within the output solution, the detection module including a detection surface configured to capture the target amplicon to produce the signal; reading a result associated with the signal; and discarding, after the reading, the stand-alone molecular test device. - View Dependent Claims (18, 19, 20, 21)
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Specification