Research progress on commutability of biological reference standards
10.13200/j.cnki.cjb.004571
- VernacularTitle:生物标准物质互换性的研究进展
- Author:
ZHANG Xuanxuan
- Publication Type:Journal Article
- Keywords:
Biological reference standards;
Commutability;
Diagnostic reference standards;
Vaccine reference standards;
Therapeutic biological product reference standards
- From:
Chinese Journal of Biologicals
2025;38(10):1247-1252
- CountryChina
- Language:Chinese
-
Abstract:
As a critical quality attribute to ensure the accuracy and comparability of the results of reference standards in different detection systems, commutability has attracted increasing attention in related research fields. The World Health Organization(WHO) has issued several technical reports and guidelines to clarify its definition, evaluation requirements. The American Clinical and Laboratory Standards Institute(CLSI), the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC) and relevant departments in China have also successively issued relevant guidelines and specifications. At present,commutability evaluation has been widely practiced in diagnostic reference standards, but there is still a lack of systematic research in the field of vaccine and therapeutic biological product reference standards. This paper systematically sorts out the relevant documents on the research on the commutability of reference standards, and summarizes the research progress in this field, so as to provide ideas and reference for the in-depth research on the commutability of biological reference standards.
