Soluble transferrin receptor (sTfR) concentration quantified using two sTfR kits: analytical and clinical performance characteristics.

We compared the analytical and clinical performance characteristics of the Ramco and R&D Systems enzyme-linked immunosorbent assays (ELISAs) for quantifying serum levels of soluble transferrin receptor (sTfR). In addition, we determined both the number of samples required to determine the true individual mean sTfR concentration for a single individual and the critical difference (CD) between serial measurements that indicates a statistically significant change in sTfR concentration. sTfR concentration was determined in 127 serum samples selected retrospectively from males (n=32) and non-pregnant (n=40) and pregnant women (n=55). Intra- and inter-assay precision for both methods was good (CV values 5--10%) to excellent (CV values <5%) over a wide range of sTfR concentrations. Correlation between these methods was good (r=0.93); however, sTfR values by the R&D kit were approximately 2.9 times higher than values obtained using the Ramco kit on the same serum samples. Nevertheless, receiver-operator characteristic (ROC) curve analysis demonstrated that the diagnostic accuracy of both assays in discriminating between patients with iron-deficiency anemia (IDA) or anemia of chronic disease (ACD) was high (area-under-the-curve (AUC) values >0.95) and not significantly different (P=0.480). We determined that a minimum of 8 samples are required to determine an individual's true sTfR concentration, while a >40% difference between serial sTfR measurements would be required to indicate a statistically significant change in sTfR concentration. We concluded that both the Ramco and R&D Systems sTfR methods have similar analytical and clinical performance characteristics and were likely to be equally useful in discriminating between patients with biochemically defined IDA or ACD.