Deploying Robotic System in the PCR Testing: The Regulatory Basis for the Medicine in the Era of Automation
Since the outbreak of COVID-19, the public health agencies have been seriously challenged by the pandemic; countries tried to accelerate the quality and quantity of PCR test and tried to improve the storage of testing reagent with different solutions. In Taiwan, TFDA authorized case-by-case on the importation of test reagent for the emergency use and assisted the domestically produced test reagent. In Japan, the robot manufacturer developed an automated PCR viral testing robot system in crowded places, such as airports and stadiums to speed up the test and ceased the infection risk when the health professionals collected the sample. There was also an automated system for the analysis of the novel coronavirus, which the pre-process could automatically conduct the gene analysis to the positive sample, monitor the infection status of the sample and detect new variants. In the Netherlands, the research institute developed a pioneering automated test robot, which claimed to be the fastest and most accurate robotic test system.