TY - JOUR
T1 - Multisite evaluation of a monoclonal IMMULITE erythropoietin immunoassay
AU - Owen, William E.
AU - Lambert-Messerlian, Geralyn
AU - Delaney, Cabrini
AU - Christenson, Robert
AU - Plouffe, Bertrand
AU - Ludewig, Rocio
AU - Woods, Anne
AU - Lei, Jyh Dar
AU - Thompson, Stephan
AU - Roberts, William L.
AU - Straseski, Joely A.
N1 - Generated from Scopus record by KAUST IRTS on 2023-09-20
PY - 2014/2/1
Y1 - 2014/2/1
N2 - 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.
AB - 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.
UR - https://linkinghub.elsevier.com/retrieve/pii/S0009912013005419
UR - http://www.scopus.com/inward/record.url?scp=84893780245&partnerID=8YFLogxK
U2 - 10.1016/j.clinbiochem.2013.11.012
DO - 10.1016/j.clinbiochem.2013.11.012
M3 - Article
SN - 0009-9120
VL - 47
SP - 216
EP - 219
JO - Clinical Biochemistry
JF - Clinical Biochemistry
IS - 3
ER -