A sandwich ELISA based on anti-apo(a) and anti-apo B monoclonal antibodies for lipoprotein(a) measurement.

Lipoprotein(a) (Lp(a)) is one of the most important independent risk factors for the prediction of premature atherosclerosis. Lp(a) is a low-density lipoprotein (LDL)-like particle which contains a glycoprotein (apoprotein(a)) disulfide linked to apo B-100. We describe a sandwich ELISA based on an anti-apo(a) monoclonal antibody (MAb) and an anti-apo B MAb for the quantitative determination of Lp(a) in human serum. The assay is sensitive, precise and specific. Samples with different apo(a) isoforms had a linear response in a range of 3-70 mg/dl of Lp(a). Correlations between the ELISA and a commercial ELISA, an immunoradiometric assay and electroimmunodiffusion were 0.92, 0.96 and 0.98, respectively. The frequency distribution of Lp(a) concentration in blood donors showed the skew toward the right reported in other populations. Patients with angiographically assessed coronary atherosclerosis had three times higher levels of Lp(a) than those with no signs of coronary atherosclerosis.