Abstract

A new point-of-care test (POCT) clinical diagnostic system, which was developed for use in emergency room or intensive care unit, will be presented. A simple spiral microchannel-based reaction cell, which delivers the well-established benefits of microfluidics in terms of high sensitivity, rapid assays and ultra-low sample volumes, is introduced and discussed for its commercial application. The fluidic cell has been extensively explored and validated as an ultra-high sensitive immunoassay platform, which is a simple yet elegant integration of microfluidics into immunoassay systems for in vitro diagnostics (IVD). The POCT system can perform rapid and real-time assays with ultra-high sensitivity, and wide-dynamic range for cardiac health diagnostics or infectious diseases. As an academic researcher, the lesson learned from the commercialization will be shared and discussed. Furthermore, 101 rules for the start-up bio-venture of POCT diagnostics will be recommended based on the speaker’s experience.