Devices and methods for molecular diagnostic testing

A method of detecting a target nucleic acid using a molecular diagnostic test device, comprising:

• coupling the molecular diagnostic test device to a power source;
• conveying, via a sample input opening, a biological sample into the molecular diagnostic test device, the molecular diagnostic test device comprising a flow path within which the biological sample is received via the sample input opening, a reaction volume within the flow path, a control module, and a heater;
• actuating the molecular diagnostic test device to cause the molecular diagnostic test device to:
• provide power from the power source to the heater;
• regulate, via the control module, the power from the power source to the heater based on a temperature set point to amplify, within the reaction volume, the target nucleic acid within the biological sample to produce a target amplicon;
• and
• react, within the molecular diagnostic test device, each of the target amplicon and a reagent formulated to produce a signal indicating a presence of the target amplicon within the biological sample;
• and
• reading a result associated with the signal,
• wherein the molecular diagnostic test device is a stand-alone molecular diagnostic test device that does not use any external instrument to perform the amplifying and reacting steps.

A method of detecting a target nucleic acid within a biological sample using a molecular diagnostic test device, comprising:

• accessing at a decentralized location the molecular diagnostic test device, the molecular diagnostic test device comprising a housing, a sample input portion, a flow path configured to receive the biological sample from the input portion, a reaction volume within the flow path, a control module, a heater, and a power source, the flow path, the control module, the heater, and the power source being contained within the housing;
• conveying the biological sample into the sample input portion of the molecular diagnostic test device;
• and
• actuating the molecular diagnostic test device to cause the molecular diagnostic test device to:
• provide power from the power source to the heater to amplify, within the reaction volume, the target nucleic acid within the biological sample to produce a target amplicon;
• and
• react, within the molecular diagnostic test device, each of the target amplicon and a reagent formulated to produce a signal indicating a presence of the target amplicon within the biological sample;
• reading, from an outer surface of the housing, a result associated with the signal;
• and
• discarding, after the reading, the molecular diagnostic test device,
• wherein the molecular diagnostic test device is a stand-alone molecular diagnostic test device that does not use any external instrument to perform the amplifying and reacting steps.