New automated chemiluminescent assay for erythropoietin.

Erythropoietin (EPO) is a polypeptide hormone produced by the kidney that regulates erythropoiesis by controlling the proliferation and differentiation of erythroid progenitors in bone marrow. Assays for EPO are used to monitor dosage and response to human recombinant erythropoietin also may have diagnostic utility in the differential diagnosis of anemia and polycythemia. We evaluated an automated, chemiluminescent immunoassay for EPO (DPC Immulite) in terms of precision, linearity, interference, and correlation with reference assays. The Immulite assay demonstrated acceptable correlation with the reference immunochemiluminometric method (slope = 1.087, y intercept = 0.567, R value = 0.990). Within-run CVs ranged from 2.3% to 5.0%, while between-run CVs ranged from 4.1% to 9.5%. Linearity extended beyond the manufacturer's stated claims, and recovery ranged from 96.8% to 100.9% across the concentrations tested. No significant interference was noted with hemoglobin, bilirubin, or triglyceride. Overall, this method compares favorably with the existing immunochemiluminometric reference method and offers clinical laboratories an alternative for the analysis of erythropoietin.