China's NMPA perspective on the clinical performance of SARS-CoV-2 antigen test reagents
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
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| Enthalten in: |
Bioanalysis - 14(2022), 6 vom: 21. März, Seite 317-324 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lv, Yunfeng [VerfasserIn] |
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| Links: |
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| Themen: |
Ag-RDTs |
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| Anmerkungen: |
Date Completed 14.03.2022 Date Revised 14.03.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.4155/bio-2021-0176 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM337202087 |
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| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 7 | |a Reagent Kits, Diagnostic |2 NLM | |
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| 700 | 1 | |a He, Jingyun |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Chao |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Rongzhi |e verfasserin |4 aut | |
| 700 | 1 | |a Zheng, Shengwei |e verfasserin |4 aut | |
| 700 | 1 | |a Fang, Li |e verfasserin |4 aut | |
| 700 | 1 | |a Han, Congyin |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Ran |e verfasserin |4 aut | |
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