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Rapid Single-use PCR-based Nucleic Acid Testing

The goal of this project is to establish the first rapid PCR-based test kits where the reagents are co-packaged with a disposable thermocycling instrument.
Categories
Vaccines
Equipment and Supplies

Industry Need

  • Increase the ability to perform nucleic acid analysis in a variety of PON settings 

Solution

The project objectives include:  

  1. Instrument and detection system design which will leverage recent technical breakthroughs to design and build a portable thermocycling instrument.  
    1. This will be achieved by integration of a hardware platform that imposes a prescribed temperature gradient to the PCR reagents using: 
      1. Resistive heating under battery power  
      2. Multi-well PCR tubes that support convective thermocycling and detection 
      3. Fluorescence analysis components 
  2. Assay development and validation which will be achieved by quantifying performance characteristics of thermocycling instrument and identify optimal design for protocol development. 
    1. This will involve evaluating a test panel of single- and multiplex amplification reactions to establish performance benchmarks pertinent to cell-based manufacturing, vaccine manufacturing, and diagnostic scenarios.  
    2. This will also establish a framework for optimal primer design and introduce protocols
  3. The platform including instrument configuration, user interface, and standardized assay test kits design will be finalized. 



Outcomes and Impacts

The development of single-use PCR-based nucleic acid testing will catalyze a radical shift in biomanufacturing and diagnostics by enabling gold standard nucleic acid analysis to be routinely performed in virtually any PON setting.

In addition, the completion of this project will lay the groundwork for efforts to organize manufacturing partners, initiate regulatory processes, and engage in customer discovery so that deployment can begin immediately upon project completion.

Updates, Related Publications, and Deliverables

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Project Lead

Texas A&M University System

Texas A&M University System