Performance characteristics of the IMMULITE 2000 erythropoietin

Background: Erythropoietin (EPO) is a glycoprotein hormone produced by specialized cells in the kidney that acts as the primary regulator of erythropoiesis. Serum EPO measurements are useful for diagnostic evaluations of anemia and polycythemia. Methods: The IMMULITE 2000 is an automated random access immunoassay analyzer for the central laboratory. The limit of detection (LOD), linearity, imprecision, comparison to another commercially available assay, and reference interval of a new EPO assay for this analyzer were assessed. Results: The LOD was 0.2 U/l. The assay was linear within an allowable systematic error of 10% over the range tested (2-178 U/l). The total imprecision of the new assay was < 7% for concentrations from 15.8 to 68.4 U/l. Comparison with the Advantage EPO assay method showed comparable results. Deming regression analysis gave a slope of 1.13 +/- 0.02, an intercept of -1.09 +/- 0.97, and a S-y/x, of 7.1 (r = 0.99) over the range tested (2-200 U/l). Conclusions: The IMMULITE 2000 EPO assay shows acceptable performance and is suitable for routine clinical use. (C) 2003 Elsevier B.V. All rights reserved.