Technical requirements of the pathogen-specific IgM qualitative detection reagents
10.3760/cma.j.issn.1009-9158.2013.10.022
- VernacularTitle:病原体特异性IgM定性检测试剂的技术要求
- Author:
Yaohua LI
- Publication Type:Journal Article
- Keywords:
Immunoglobulin M;
Reagent kits,diagnostic;
Indicators and reagents;
Registries;
Evaluation studies
- From:
Chinese Journal of Laboratory Medicine
2013;36(10):947-949
- CountryChina
- Language:Chinese
-
Abstract:
To offer the guidance of the registration application of in vitro diagnostic (IVD) reagents,the technical requirements for registration of the pathogen-specific Immunoglobulin M (IgM) qualitative test reagents were discussed.The application paperwork including the evaluation of analytical performance was analyzed based on the the legal requirement from the China Food and Drug Administration (CFDA)and the experience of the IVD registration.
