Abstract:

Lipoprotein（a）[Lp（a）] is a predictive factor for evaluating the risk of cardiovascular diseases. However,there is no comparability for the results of Lp（a） determinations. So,Lp（a） determination can not be applied widely. Although its reference method and reference materials have been established in 2003,until now,commercial reagents expressing the results as nmol/L just appear. Then,determination results can be traced to World Health Organization （WHO）/ the International Federation of Clinical Chemistry and Laboratory Medicine（IFCC）standard reference material（SRM）2B. This article introduces the causes of result inconsistency,the progress of Lp（a） determination standardization and a valuable example about Roche research. In the guidance of Professor Marcovina from the Northwest Lipid Research Laboratories（NWLRL）at the University of Washington,Roche overcomes the influence of apolipoprotein （apo）（a） kringle structure on the determination of Lp（a）,which makes routine determination system being traceable to WHO/IFCC SRM 2B and related results with comparability.

Key words: Lipoprotein（a）, Reference materials, Traceability