Abstract

Point-of-Care Molecular Testing Platform for COVID Testing and Lessons Learned

Ming Tan, CTO, Wainamics Inc.

Point-of-care (POC) molecular testing allows rapid direct measurement of the molecular signature in infectious diseases. This allows for identification of the infectious agent at low copy numbers. Wainamics has developed multiple SARS-CoV2 testing platforms in collaborations with our partners, including AmplifiDX and UC Berkeley Innovative Genomic Institute. We present here a unique approach for rapid development of disposable microfluidic systems for nasal swab or saliva sample testing, as well as the lessons learned during the development cycle. The key technology is Wainamics’ innovative, patented microfluidic cartridge that allows sample to answer detection. It has a single lysing solution blister on cartridge that releases lysing solution to the sample chamber. Primer and master mix are sealed on cartridge. The cartridge does not contain any moving parts or integrated on cartridge valves. The cartridge is manufactured using injection molding and die-cut lamination, allowing low cost and high-volume manufacturing. Our platform requires minimum training. After inserting sample into the cartridge, the user simply inserts the cartridge into the machine. All bio-assay steps are performed automatically in the instrument.