Recently, China’s NMPA (National Medical Products Administration, formerly CFDA) formally released the industry standards for Nucleic Acid Extraction Kits (Magnetic Bead Method). It is reported that the project to set up the official standards was led by Xi'an Tianlong Technology, and jointly developed Anhui Provincial Hospital, Beijing Institute of Medical Device Testing, National Institutes for Food, as well as various other IVD enterprises including Guangzhou Darui Biotechnology, Sansure Biotech, Shanghai Fosun Long March, Shanghai Kehua Bio-Engineering, and Suzhou Beaver Biomedical.
The standards of the classification, technical requirements, and test methods, etc., of nucleic acid extraction kits (magnetic bead method), are now specified, which fill the gaps in this field and will advance the long-term development of this industry, and is of great significance for the prevention and control of the COVID-19 epidemic at this point.