Abstract：
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.
摘要：
目的：本研究旨在分析SARS-CoV-2抗原检测的临床试验要求，以探讨临床试验的合理性和科学性。方法:比较SARS-CoV-2抗原试验的上市指南,分析临床试验的要求,找出我国之间的异同,美国和欧洲。结果:中国SARS-CoV-2抗原试验的临床试验要求,美国和欧洲在方法上是一致的。然而,在方案设计要求方面存在差异.结论:临床试验要求的差异源于不同地区的法规和实际情况,但所有的临床试验都是为了获得有效的产品临床性能。
