(Yicai Global) March 3 -- Ge Junbo, the academician leading Shanghai-based development of a Covid-19 testing re-agent, expects the kit to get a medical device registration certificate in the near future.
"If everything goes well, we'll get the certificate soon," Ge told Yicai Global in an interview. "The clinical validation of our antibody detection re-agents is very good. Clinical tests have been started on 1,000 patients."
New medical devices in China must obtain government approval before going on sale, and the National Medical Products Administration has already emergency approved three antibody detection re-agents made domestically.
The testing re-agent, developed by Shanghai Fudan University and Zhongshan Hospital, has already completed the first phase of clinical trials, involving 310 patients in Jiangsu, Chongqing, Shanghai and other regions. It has a specificity of 99.6 percent and an overall diagnostic compliance rate of 98.1 percent.
The kit can be even more accurate when used in combination with commonly used nucleic acid detection re-agents, which when used alone have had issues in diagnosing in several countries. Ge expects the new test will become the standard for assessing whether or not Covid-19 patients are fit to be discharged.
Editors: Tang Shihua, James Boynton