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Several commercial methods have been proposed for lipoprotein(a) (Lp(a)) measurements over the past decades. However, only a few of them appear completely suitable in terms of analytical performance, costs and practicability. We evaluated the analytical performance of a new commercial fully automated immunonephelometric assay for Lp(a) measurements on the IMMAGE ®  Immunochemistry System. Mean within- and between-run coefficients of variation were 2.7 % (range 1.2–4.7 %) and 3.8 % (range 1.8–7.9 %), respectively. The linearity of the assay was confirmed up to 102 mg/dl and the deviation from the expected values did not exceed 4% (mean deviation: 1.9%). Moreover, the relative non-linearity was acceptable, ranging from 1.4 % to 1.6 % and hence constantly lower than the 2.5 % upper limit. Since there is no reference method for Lp(a) measurements, 100 routine random serum samples measured by the IMMAGE ®  Immunochemistry System immunonephelometric assay were further compared with two other commercial immunonephelometric assays (Array ®  LPA immunonephelometric assay and BNA Latex-Enhanced Lp(a) nephelometric assay). Non-parametric regression and relative Spearman's correlation coefficients were satisfactory, ( y  = 1.009x−1.38; r = 0.998 IMMAGE ®  Immunochemistry System vs. Array LPA and  y  = 0.922x−0.40; r = 0.989 IMMAGE ®  Immunochemistry System vs. Behring Nephelometer Analyzer (BNA) Latex Lp(a) assay). On the basis of the results of the present evaluation we conclude that the analytical performance and the main technical features of the IMMAGE ®  Immunochemistry System immunonephelometric assay make it a suitable method for Lp(a) measurement in clinical laboratories.

Evaluation of the Analytical Performances of a New Fully Automated Commercial Immunonephelometric Assay for Lipoprotein(a)