Analytical performance of the Genzyme LipoPro Lp(a) kit for plasma lipoprotein(a)-cholesterol assay

The analytical performance of a new assay for plasma lipoprotein(a)-cholesterol (Lp[a]-C) was compared with that of our existing Lp(a) protein assay. The Lp(a)-C assay utilises lectin affinity chromatography to isolate intact Lp(a) particles. The effect of apo(a) isoform size on this system was assessed and found to be negligible. Plasma Lp(a) concentrations measured by both assays were in excellent accord in 24 subjects with Lp(a) protein concentrations ranging from 1-65 mg/dL (r2 = 0.916). Linearity of the Lp(a)-C assay system was excellent (r2 = 0.997) and within-run precision was 6.9% at an Lp(a)-C concentration of 0.3 mmol/L. Between-calibration precision was checked and proved to be 7.9%. The lectin-binding reagent used in the assay bound different sized apo(a) isoforms equally, and the recovery of Lp(a) from the reagent was, on average, 64%. We conclude that the Lp(a)-C assay system performs well but that further information is required on what new information, if any, the assay provides over traditional Lp(a) protein measurements by enzyme-linked immunosorbent assay (ELISA) or immunoturbidimetry.