Multisite evaluation of a monoclonal IMMULITE erythropoietin immunoassay

William E. Owen, Geralyn Lambert-Messerlian, Cabrini Delaney, Robert Christenson, Bertrand Plouffe, Rocio Ludewig, Anne Woods, Jyh Dar Lei, Stephan Thompson, William L. Roberts, Joely A. Straseski

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Background: Erythropoietin (EPO) measurements are useful in diagnosing anemias and polycythemias. We conducted a multisite evaluation of a monoclonal IMMULITE EPO immunoassay.11Not available for sale in the U.S. Product availability varies by country. 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). +. 2.57. IU/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). 3.51. IU/L, r. =. 0.98 and (IMMULITE 1000). =. 0.95(ACCESS 2). +. 0.52. IU/L, r. =. 0.95. Total imprecision ranged from 6.4% to 10.3% and linearity was confirmed from 3.5 to 562. IU/L. LoB, LoD, and functional sensitivity were 0.5, 1.0, and 1.5. IU/L, respectively. The assay was highly specific for EPO. Nonparametric reference interval was 4.3 to 29.0. IU/L (n. =. 170). Conclusions: The monoclonal IMMULITE EPO assay showed acceptable performance for EPO measurement. © 2013 The Canadian Society of Clinical Chemists.
Original languageEnglish (US)
Pages (from-to)216-219
Number of pages4
JournalClinical Biochemistry
Volume47
Issue number3
DOIs
StatePublished - Feb 1 2014
Externally publishedYes

ASJC Scopus subject areas

  • Clinical Biochemistry

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