New assay of apolipoproteins A-I and B by rate nephelometry evaluated.

We evaluated new, commercially available reagents for assaying apolipoproteins (apo) A-I and B by rate nephelometry (INA). Our initial linearity studies for apoA-I indicated that use of the commercial diluent resulted in incomplete immunoreactivity. Subsequent revision of the calibration line by the manufacturer compensated for this and improved the linearity for the apoA-I assay. We observed good linearity for the apoB assay. The within-run CVs were less than 4.0% and the between-run CVs were less than 5.5% for both assays. Results were 109% for apoA-I and 101% for apoB as compared with those measured for IUIS-WHO reference materials from the Centers for Disease Control. Recovery averaged 103% for apoA-I and 105% for apoB, for duplicate assays of three concentrations of purified apoA-I and low-density lipoprotein (LDL). Assaying sera from 45 patients, we demonstrated a good correlation between INA and radial immunodiffusion for both apoA-I (r = 0.92) and apoB (r = 0.95). Correlations between apoA-I and high-density lipoprotein cholesterol, and between apoB and LDL cholesterol compared favorably with previous reports. We conclude that these assays are accurate, precise, and easily automated for clinical application.