Reference Materials for the Standardization of the Apolipoproteins A-I and B, and Lipoprotein(a)

Measurement of the apolipoproteins A-I and B, and lipoprotein(a) enable identification of individuals at increased risk of cardiovascular disease. However, the lack of standardized methods to measure these risk markers has resulted for many years in the non-comparability of values and often a conflicting interpretation of clinical studies. Due to the collaborative efforts of the International Federation of Clinical Chemistry and Laboratory Medicine, research organizations, clinical chemistry laboratories and diagnostic companies, secondary reference materials for the apolipoproteins A-I and B, and lipoprotein(a) have been prepared and tested for their ability to harmonize test values. SP1-01 and SP3-07 WHO-IFCC reagents are now available to manufacturers for use in the value transfer of apolipoprotein A-I and B values to master calibrators, and PRM is proposed to be the secondary reference material for Lp(a). By the worldwide use of such reference materials a better traceability and standardization of measurement is being achieved in the clinical laboratories.