China's NMPA perspective on the clinical performance of SARS-CoV-2 antigen test reagents
| Autor: | Yunfeng Lv, Yu Gao, Jingyun He, Chao Xu, Rongzhi Liu, Shengwei Zheng, Li Fang, Congyin Han, Ran Li |
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| Rok vydání: | 2022 |
| Předmět: |
China
Clinical Trials as Topic SARS-CoV-2 Clinical Biochemistry General Medicine COVID-19 Serological Testing Specimen Handling Analytical Chemistry Medical Laboratory Technology COVID-19 Nucleic Acid Testing Humans Indicators and Reagents Reagent Kits Diagnostic General Pharmacology Toxicology and Pharmaceutics Antigens Viral |
| Zdroj: | Bioanalysis. 14:317-324 |
| ISSN: | 1757-6199 1757-6180 |
| DOI: | 10.4155/bio-2021-0176 |
| Popis: | The COVID-19 pandemic continues to spread all over the world. In the process of emergency use authorization, the Center for Medical Device Evaluation of the China National Medical Products Administration issued ‘Key Points of Technical Review for the Registration of SARS-CoV-2 Antigen/Antibody Detection Reagents’ as the guidance of registration of antigen and antibody test reagents for the industry. In this document, clinical evaluation requirements of antigen detection reagents are elaborated. Based on the Key Points document and the authors’ review practice, this article explains the evaluation methods and requirements of clinical performance of SARS-CoV-2 antigen-detecting rapid diagnostic tests, then analyzes the application scenarios and intended use of antigen detection reagents. |
| Databáze: | OpenAIRE |
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