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

Lv, Yunfeng; He, Jingyun; Liu, Rongzhi; Gao, Yu; Xu, Chao; Hu, Peng; Zheng, Shengwei; Fang, Li; Li, Ran; Han, Congyin; An, Juanjuan; Dong, Jinchun

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 terms of reference methods and subject enrolment among others, which can ensure that the test results can meet the clinical needs. This article draws on the experience of the China NMPA in evaluating diagnostic reagents used to supplement the gold standard test method in the early stage of an epidemic of an infectious disease, as well as to serve as reference for clinicians and regulators.