关键词: 检验医学, 体外诊断产品, 参考系统, 量值溯源

Abstract:

The reference system research based on metrological traceability is an important research topic in the field of laboratory medicine,and it is also an important research direction for in vitro diagnosis product（IVD） enterprises to improve product quality and influence. The accuracy and reliability of test results are important guarantees for clinical diagnosis,treatment and prevention. In this review,from the perspective of IVD enterprises,basic situation and classification of medical reference system are briefly described. The reference system applied in IVD enterprises of China were introduced from the aspects of reference measurement procedures,reference materials and uniformity. The existing problems,such as the current number of reference methods and reference materials,can not meet the demand of enterprises and clinical applications,IVD industry understanding of metrological traceability and standardization is not perfectly enough,there is a lack of laboratory network for reference measuring service,were summarized. It is expected to provide a reference for the researchers of reference system of laboratory medicine.

Key words: Laboratory medicine, In vitro diagnosis product, Reference system, Metrological traceability