Abstract
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. J. Clin. Lab. Anal. 14:271–233, 2000. © 2000 Wiley‐Liss, Inc.
Keywords: immunoassay, anemia, polycythemia, kidney, hormone
REFERENCES
- 1. Lee GR, Foerster J, Lukens J, Paraskevas F, Greer J, Rodgers GM, editors. Wintrobe’s clinical hematology. Baltimore: Williams & Wilkins; 1999. 184 p. [Google Scholar]
- 2. Marsden JT, Sherwood RA, Peters TJ. 1999. Evaluation of six erythropoietin kits. Ann Clin Biochem 36:380–387. [DOI] [PubMed] [Google Scholar]
- 3. Carneskog J, Kutti J, Wadenvik H, Lundberg P, Lindstedt G. 1998. Plasma erythropoietin by high‐detectability immunoradiometric assay in untreated and treated patients with polycythaemia vera and essential thrombocythaemia. Eur J Haematol 60:278–282. [DOI] [PubMed] [Google Scholar]
- 4. Lindstedt G, Lundberg P. 1998. Are current methods of measurement of erythropoietin (EPO) in human plasma or serum adequate for the diagnosis of polycythaemia vera and the assessment of EPO deficiency? Scand J Clin Lab Invest 58:441–458. [DOI] [PubMed] [Google Scholar]
- 5. Marsden JT, Sherwood RA, Hillis A, Peters TJ. 1993. Monitoring erythropoietin therapy for anaemia of chronic renal failure by serum erythropoietin assays. Ann Clin Biochem 30:205–206. [DOI] [PubMed] [Google Scholar]
- 6. Birgegard G, Wide L. 1992. Serum erythropoietin in the diagnosis of polycythemia and after phlebotomy treatment. Br J Haematol 81:603–606. [DOI] [PubMed] [Google Scholar]
- 7. Tanebe M, Teshima S, Hanyu T, Hayashi Y. 1992. A rapid and sensitive method for erythropoietin determination in serum. Clin Chem 38/39:1752–1755. [PubMed] [Google Scholar]
- 8. Tefferi A. 1999. Diagnosing polycythemia vera: a paradigm shift. Mayo Clin Proc 74:159–162. [DOI] [PubMed] [Google Scholar]
- 9. Shih L‐Y, Lee C‐T, See L‐C, et al. 1998. In vitro culture growth of erythroid progenitors and serum erythropoietin assay in the differential diagnosis of polycythaemia. Eur J Clin Invest 28:569–576. [DOI] [PubMed] [Google Scholar]