A new on-site nucleic acid detection system for quick identification of the SARS-CoV-2 that causes COVID-19 was recently developed by a research team at the Suzhou Institute of Biomedical Engineering and Technology (SIBET) of the Chinese Academy of Sciences.
The system is based on hybrid capture immunofluorescence analysis (HC-IFA) and requires only 20 μl of swab or sputum samples, making it easy and convenient to use. As a result, RNA from the novel coronavirus can be detected quickly, thus providing accurate and reliable data for real-time monitoring of the COVID-19 pandemic.
"The system can detect suspected cases rapidly with a qualitative result in 45 minutes. In addition to its high efficiency, the instrument is portable and can be stored and transported at normal temperature," said WANG Daming, one of the team's lead researchers.
The National Medical Products Administration (NMPA) approved the test kit and granted it a medical device product registration certificate on March 24. As well, the detecting instrument used in the system received a medical device registration device certificate in 2017.
The system also obtained Conformité Européenne (CE) certification on April 9.
With approval by both Chinese and EU authorities, the scientists hope the quick detection system will soon be used both in the EU and China to support the needs of healthcare and research institutions to quickly identify cases of COVID-19.