Abstract
An optimal level of circulating red blood cells or hemoglobin for oxygen transport is under the hormonal control of erythropoietin (EPO). The importance of EPO in anemia and polycythemia has been demonstrated. Historically, EPO determination has been costly and time consuming. It has become increasingly evident, however, that the knowledge of a patient's EPO levels would be valuable in the diagnosis and treatment of erythropoietic disorders. The purpose of this project was to conduct an independent clinical trial study of an EPO enzymelinked immunoassay (ElA) marketed by JCL ClinicalResearch. When this study was compared to the reference method of analysis, the polycythemic mouse bioassay, a high level of correlation was demonstrated. A separate comparison study of values obtained with EPO kits of different manufactured lots demonstrated acceptable correlation and reproducibility between samples from healthy and anemic groups of individuals. Reproducibility data demonstrate statistical similarity between the means from multiple analysis of a single sample with kits of different lots. An acceptable level of between-day precision and sensitivity was obtained from samples with low, normal, and elevated EPO values. This study demonstrates the EPO-EIA to have a level of sensitivity and reproducibility necessary for clinical laboratory determination of EPO.
Published Version
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