Technical Guideline on the Registration of Cryptococcal Antigen Detection Reagent (draft)

On August 21, 2020, CMDE announced its preparation of Technical Guideline on the Registration of Cryptococcal Antigen Detection Reagent (draft). The “cryptococcal antigen” referred to in these guidelines is “cryptococcal capsular polysaccharide antigen”. It is suitable for the qualitative detection in vitro of cryptococcal capsular polysaccharide antigens from human samples, such as serum and/or plasma and/or whole blood and/or cerebrospinal fluid, based on the principle of antigen antibody reaction by elisa (enzyme-linked immuno sorbent assay), latex agglutination test and lateral immunochromatography. All kinds of opinions are welcome to be filled in the information collection form and submit it to CMDE before September 19, 2020 via email.

Link: https://www.cmde.org.cn/CL0065/21525.html