Comparison of requirements for clinical study of SARS-CoV-2 antigen test kits in China, the USA and Europe

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. 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. 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. 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.