Comparison of requirements for clinical study of SARS-CoV-2 antigen test kits in China, the USA and Europe-Reference-Cited by-同舟云学术

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

Published:2023-05 Issue:10 Volume:15 Page:581-589
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Lyu Yunfeng¹^ORCID,Zhu Yuting²,Zhang Ying³,Hou Yuanyuan⁴,Zhang Yining⁵,He Jingyun¹,Deng Gang¹

Affiliation:

1. Center for Medical Device Evaluation, National Medical Products Administration, China

2. Fujian Center For Drug Evaluation & Monitoring, China

3. Shanghai Center For Medical Device & Cosmetics Evaluation & Verification, China

4. Hainan Center for Drugs & Medical Devices Evaluation & Service, China

5. Beijing Institute of Medical Device Testing, Beijing Center for Testing & Research of Medical Biological Protective Equipment, China

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.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

https://www.future-science.com/doi/pdf/10.4155/bio-2023-0042

Reference33 articles.

1. Considerations for diagnostic COVID-19 tests

2. Applications of the High Impact Practices in Family Planning during COVID-19

3. Comparison of the SARS-CoV-2 Rapid antigen test to the real star Sars-CoV-2 RT PCR kit

4. Development and clinical application of a rapid IgM‐IgG combined antibody test for SARS‐CoV‐2 infection diagnosis

5. Center for Medical Device Evaluation of the China National Medical Products Administration, Beijing, China. Key Points of Technical Review for Registration of SARS-CoV-2 Antigen/Antibody Detection Reagents (Trial Version). www.cmde.org.cn/CL0004/20512.html (2020).