Human serum Lp(a), APOA-I, APOB

Objectives: The procurement is for obtaining fresh (never frozen) human serum samples intended for the production of international serum certified reference materials (CRMs) for lipoprotein(a) (Lp(a)), apolipoprotein A-I (ApoA-I), and apolipoprotein B (ApoB). These CRMs are critical for clinical chemistry due to EU regulations on in vitro diagnostic medical devices that require traceability of calibrants and control materials. The tender is split into three lots: serum donations with specific levels of Lp(a), serum donations with specific levels of ApoA-I and ApoB, and serum donations with very high levels of Lp(a). Each lot has a specified minimum and maximum number of donations required.