The biotechnology research team from National Chiao Tung University (NCTU) announced on October 27 that they had developed a unique “full quantitative” rapid test system. The system only takes 5 minutes to determine the COVID-19 nucleic acid, antigen, and antibody amounts in human body. With those data, the level of infection can be analyzed to accurately judge whether the patient was contracted with the disease recently or carried antibodies after recovery from the disease.
The research team is composed of the Department of Biological Science and Technology of NCTU, AgriTalk, AllBio, and Bio Smart Co. Ltd. Under the guidance of NCTU Lifetime Chair Professor Jason Yi-Bing Lin, the team researched and developed the “AllCHECKTM Compositional Electronic Chip Platform,” which can accurately detect whether COVID-19 antibodies, antigens, or nucleic acids exist in the human body from a whole blood sample (0.02 mL) within 5 minutes. Professor Lin stated that the quantitative test system can monitor patients’ in vivo infection variation in real time and enables first-line medical personnel to adopt isolation or other medical treatments for the patient according to patient conditions.
The electronic chip platform is composed of biosensor chips and electrochemical sensing devices. The chips have high reproducibility (>96%), high accuracy (>95%), and high stability (>94%), conforming to the international error requirements established by the Clinical and Laboratory Standards Institute. The electrochemical sensing device possesses system sensibility (antibody/antigen test: 1 pg/mL; nucleic acid test: 1 fM) and precision (clinical sample precision >99%) in compliance with the certification standards of Conformité Européenne (CE) and Taiwan Food and Drug Administration (TFDA).
Currently, the team has developed rapid test kits for antigens and antibodies and acquired CE and TFDA certifications. Based on the certified kits, a unique highly sensitive electronic chip platform system is further developed. The technology will be able to be applied as an efficient protective device to effectively prevent large scale infection of the pandemic and enable timely treatment. The system can be set at venues that require massive tests such as airports, medical institutions, and public assembly areas. It can also serve as an effective solution for countries under tremendous economic losses because of the pandemic.
The electronic chip platform technology can respond to new test targets by replacing the modified biological molecules. If another new strain of virus begins to spread, development of the test technology for the new target can be completed in a week, substantially reducing the development duration of the epidemic detection measure. The team has successfully completed application to the Institutional Review Board and is ready to implement the trial. Application of the clinical trial has passed the Emergency Use Authorization of the US FDA. The technology is estimated to enter the mass production phase and be launched onto the market in 2021.