Multisite evaluation of a monoclonal IMMULITE erythropoietin immunoassay

Abstract

Background: Erythropoietin (EPO) measurements are useful in diagnosing anemias and polycythemias. We conducted a multisite evaluation of a monoclonal IMMULITE® EPO immunoassay.(1) DESIGN AND METHODS: The IMMULITE EPO assay is a solid-phase enzyme-labeled chemiluminescent immunometric assay. Method comparison to the Beckman ACCESS 2 assay using clinically characterized samples and reproducibility studies were conducted at three external independent laboratories. Internal evaluation conducted at Siemens included comparison of IMMULITE® 2000 and IMMULITE® 1000 assays to the ACCESS 2 assay; imprecision; linearity; limit of blank (LoB), limit of detection (LoD), and functional sensitivity; potential interference and cross-reactants; and reference interval determination.

Results: External method comparison gave Deming regression of (IMMULITE 2000)=0.96(ACCESS 2)+2.57IU/L, r=0.98 (n=217). Reproducibility ranged from 6.1% to 16.2%. Internal method comparisons gave Deming regressions of (IMMULITE 2000)=1.09(ACCESS 2)-3.51IU/L, r=0.98 and (IMMULITE 1000)=0.95(ACCESS 2)+0.52IU/L, r=0.95. Total imprecision ranged from 6.4% to 10.3% and linearity was confirmed from 3.5 to 562IU/L. LoB, LoD, and functional sensitivity were 0.5, 1.0, and 1.5IU/L, respectively. The assay was highly specific for EPO. Nonparametric reference interval was 4.3 to 29.0IU/L (n=170).

Conclusions: The monoclonal IMMULITE EPO assay showed acceptable performance for EPO measurement.

Keywords: Chemiluminescent immunoassay; IMMULITE; Imprecision; Interference; Method comparison; Reference interval; Serum erythropoietin.