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

Clin Chim Acta. 2007 Jul;382(1-2):112-6. doi: 10.1016/j.cca.2007.04.008. Epub 2007 Apr 24.

Abstract

Background: 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.

Methods: 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).

Results: 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 microg/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.

Conclusions: 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.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Automation
  • Clinical Chemistry Tests / instrumentation*
  • Enzyme-Linked Immunosorbent Assay
  • Humans
  • Nephelometry and Turbidimetry / instrumentation*
  • ROC Curve
  • Reagent Kits, Diagnostic*
  • Receptors, Transferrin / blood*
  • Reproducibility of Results

Substances

  • Reagent Kits, Diagnostic
  • Receptors, Transferrin