Evaluation of a fully-automated particle-enhanced turbidimetric immunoassay for the measurement of plasma lipoprotein (a).: Population-based reference values in an area with low incidence of cardiovascular disease

Objectives: Lipoprotein(a) has been pro sed as an independent risk factor for cardiovascular disease. This lipoprotein possesses a marked size-polymorphism that makes difficult to measure accurately its concentration in plasma. The International Federation of Clinical Chemistry recently recommended to carefully evaluate new commercial methods for lipoprotein(a) measurement to discard the possible influence of lipoprotein(a) isoforms on immunoreactivity. They also recommended to perform population-based studies for different ethnic and geographic groups. Therefore, in the evaluation-of a fully automated, particle-enhanced turbidimetric immunoassay for the measurement of lipoprotein(a) we have determined its reference interval in the Spanish population, an area with the lowest incidence of cardiovascular disease in Europe. Design and methods: We evaluated a commercial kit of reagents calibrated against the Proposed Reference Material and determined the effect of lipoprotein(a) size polymorphism on the, measurements. A population-based study was carried out in two different villages on the Mediterranean coast of Spain. Results: Imprecision at different lipoprotein(a) concentrations ranged between 3.0 and 15.4%. Recovery was 98.5 +/- 2.1. Detection limit was 4.8 nmol/L. There were. no-significant interferences from lipemia, jaundice, hemolysis, paraproteinemia, apolipoprotein B or plasminogen. We did not observe any effect of the lipoprotein(a) size polymorphism on the measurements. Mean (and SD) values for plasma lipoprotein(a) (n = 369) were 53.6 (65.3) nmol/L, the median was = 25.3 nmol/L and range varied between <4.8 and 356.0 nmol/L. Conclusion: The present article presents an accurate and practical assay for measuring plasma lipoprotein(a) concentrations and describes its reference values in a populalion of Spanish Caucasians. Our results are similar to those obtained in other Caucasian populations (between 10 and 25% higher than in participants of the CARDIA study). (C) 2003 The Canadian Society of Clinical Chemists. All rights reserved.