%0 Journal Article
%T Comparison of requirements for clinical study of SARS-CoV-2 antigen test kits in China, the USA and Europe.
%A Lyu Y
%A Zhu Y
%A Zhang Y
%A Hou Y
%A Zhang Y
%A He J
%A Deng G
%J Bioanalysis
%V 15
%N 10
%D 2023 May 6
%M 37278334
%F 2.695
%R 10.4155/bio-2023-0042
%X Aims: This study was designed to analyze the requirements for clinical trials of SARS-CoV-2 antigen testing to explore the rationality and scientific rigor of clinical trials. Methods: The guidelines for the listing of SARS-CoV-2 antigen tests were compared and the requirements for clinical trials were analyzed to find similarities and differences between China, the USA and Europe. Results: The requirements for clinical trials of SARS-CoV-2 antigen tests in China, the USA and Europe were consistent in terms of methods. However, differences were found in the requirements for protocol design. Conclusion: The differences in clinical trial requirements stem from regulations and the actual conditions across regions, but all clinical trials are designed to obtain valid clinical performance of products.