Evaluation of an automated soluble transferrin receptor (sTfR) assay on the Roche Hitachi analyzer and its comparison to two ELISA assays

Soluble transferrin receptor (sTfR) assays are currently not standardized. This hinders data comparison between studies and also affects the use of a recently proposed model to estimate body iron. We evaluated the analytical performance of a fully automated sTfR immunoturbidimetric assay (Roche Diag...

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Bibliographic Details
Published in:Clinica chimica acta 2007-07, Vol.382 (1), p.112-116
Main Authors: Pfeiffer, Christine M., Cook, James D., Mei, Zuguo, Cogswell, Mary E., Looker, Anne C., Lacher, David A.
Format: Article
Language:English
Subjects:
Analytical performance
Automation
Body iron model
Clinical Chemistry Tests - instrumentation
Enzyme-Linked Immunosorbent Assay
Humans
Iron deficiency
Method comparison
Nephelometry and Turbidimetry - instrumentation
NHANES
Reagent Kits, Diagnostic
Receptors, Transferrin - blood
Reproducibility of Results
ROC Curve
Soluble transferrin receptor
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Summary:Soluble transferrin receptor (sTfR) assays are currently not standardized. This hinders data comparison between studies and also affects the use of a recently proposed model to estimate body iron. We evaluated the analytical performance of a fully automated sTfR immunoturbidimetric assay (Roche Diagnostics) and compared it with two ELISA assays (Ramco Laboratories and an in-house ELISA assay used in the body iron model). The Roche assay showed excellent intra- and inter-assay precision (CV < 5%). Prolonged exposure of serum samples to room temperature and multiple freeze–thaw cycles did not affect sTfR concentrations. Receiver–operator characteristic curve analysis demonstrated that the Roche assay (area-under-the-curve (AUC) = 0.882) was superior to the Ramco assay (AUC = 0.794) in predicting iron deficiency (defined as serum ferritin < 10 μg/L; P = 0.013). Method comparison between the Roche and the two ELISA assays showed good correlations ( r > 0.8); however, sTfR values by the Roche assay were on average 30% lower than values obtained with the two ELISA assays. sTfR data measured with an immunoturbidimetric assay can be compared to a commonly used ELISA assay, and can be used in the body iron model through regression equations obtained in the present study.
ISSN:0009-8981
1873-3492
DOI:10.1016/j.cca.2007.04.008