China's NMPA perspective on the clinical performance of SARS-CoV-2 antigen test reagents.
Bioanalysis
; 14(6): 317-324, 2022 Mar.
Article
in English
| MEDLINE | ID: covidwho-1704052
ABSTRACT
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.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Specimen Handling
/
COVID-19 Serological Testing
Type of study:
Diagnostic study
/
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Country/Region as subject:
Asia
Language:
English
Journal:
Bioanalysis
Year:
2022
Document Type:
Article
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