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.
Keywords: SARS-CoV-2; antigen; clinical trial; medical devices.