System and apparatus for the hand-held amplification and detection of nucleic acids

A nucleic acid amplification and detection device comprising:

• a collection handle configured to collect a nucleic acid sample;
• a sample processing assembly in fluid communication with an amplification assembly, wherein the nucleic acid sample is introduced to the sample processing assembly and the amplification assembly through a first action of the collection handle;
• a heater assembly thermally coupled to the amplification assembly and responsive to a heater activation assembly, wherein the heater activation assembly activates the heater assembly in response to the first action of the collection handle;
• and
• a lateral flow assay configured to receive amplification products from the amplification assembly in response to a second action of a collection handle.

A device for the sequential amplification and detection of nucleic acids comprising:

• a collection handle containing a nucleic acid sample, wherein a first action of the handle causes the sample to be delivered to a processing chamber containing one or both of:
• a lysis pad;
• one or more filters;
• a transfer pad in fluid communication with the processing chamber that transmits the sample to an amplification pad containing lyophilized reagents necessary for amplification of nucleic acids present in the sample;
• a reaction housing containing a heater assembly thermal coupled to the amplification pad;
• a heater activation assembly comprising an exothermic reagent positioned within a reagent syringe and separated from the heater assembly by a reagent seal, wherein said exothermic reagent is released in response to the first action of the collection handle thereby activating the heater assembly;
• and
• a lateral flow assay separated from the amplification pad by an amplicon seal, and adapted to receive amplification products from said amplification pad in response to the second action of the collection handle.