According to the research paper Introduction to Molecular Diagnostics, rapid point to point COVID-19 diagnostics are being developed in the molecular diagnostics field. Molecular diagnostics uses a collection of techniques to analyze and capture the genetic material or proteins associated with a specific health condition or disease.
To achieve rapid, high volume diagnostics at the point of care, the DNA or RNA sequence of interests need to be amplified, a process of making millions or billions of copies from a very small sample of DNA or RNA in the raw human sample (e.g., blood, tissue, saliva, etc.), to a detectable amount. The most fundamental and widely used amplification technique is the polymerase chain reaction (PCR) method.
The majority of PCR tests use rapid thermal cycling combined with enzyme-driven DNA replication. Basic steps to perform a molecular diagnostic using PCR-based test involve:
- Extracting DNA from raw human samples by isolating and lysing cells.
- Separating and purifying extracted DNA.
- Amplifying the target gene sequence of interest out of the whole DNA sample. This process needs a heat-resistant enzyme called TAQ polymerase which drives the amplification reaction. A series of repeated thermal cycles - temperature raises and drops is applied to help accelerate the DNA replication process.
- Analyzing the amplified target DNA region.
Achieving scalable, reliable results and meeting demand
TAQ polymerase can be grown and harvested from bacterial cells (E. Coli). To liberate the enzyme from the cells, Microfluidizer® technology is an ideal solution (for lab-scale development) and can be used to directly and reliably scale up to large batches which will accommodate the massive diagnostic demand resulting from the Covid-19 pandemic.
Technology for Scalable Vaccine Production
Microfluidics supplies both lab-scale and full production scale, High Shear Homogenisers that are suitable for virus diagnostic component development and production. Read our Application Note to see how our technology is linearly scalable so that the results achieved in the lab are also possible at pilot and production-scale.