China NMPA perspective on clinical evaluation of SARS-CoV-2 antibody test reagents in the process of emergency approval

Lv Y, He J, Liu R et.al. | Regulatory | Bioanalysis Epub ahead of print Keywords: antibody test reagents • clinical evaluation • COVID-19 • emergency approval • SARS-CoV-2 • supplementary detection Coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The SARS-CoV-2 antibody testing an important supplement to nucleic acid testing. In the process of emergency approval, the Center for Medical Device Evaluation of the China National Medical Products Administration released The Key Points of Technical Review for the Registration of SARS-CoV-2 Antigen/Antibody Detection Reagents. The Clinical Study Requirement section of the Key Point has put forward requirements in...