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Susanne Kolbe-Busch, Johannes Lotz, Gerd Hafner, Norbert J.C. Blanckaert, Georg Claeys, Giovanni Togni, Jürgen Carlsen, Ralf Röddiger, Lothar Thomas

Multicenter Evaluation of a Fully Mechanized Soluble Transferrin Receptor Assay on the Hitachi and Cobas Integra Analyzers. The Determination of Reference Ranges

Soluble transferrin receptor (sTfR) is reported to be a reliable marker for the diagnosis of iron deficiency, especially when iron metabolism is influenced by inflammatory disorders such as infection, chronic inflammation and cancer-related anemia. In the present multicenter study the analytical performance of a recently introduced, latex-enhanced immunoturbidimetric assay for the determination of soluble transferrin receptor (Tina quant®[a] sTfR, Roche Diagnostics) on different fully mechanized analyzers such as Hitachi 917 and 911, and Cobas Integra 400 and 700 was evaluated. Within-run and between-run imprecision showed good results (CV<5% and <7%, respectively). The assay was found to be linear over a wide measuring range (0.4–35 mg/l). Endogenous substances did not interfere with the test results. Comparison of serum sTfR concentrations with those of heparinized plasma revealed good correlation (r>0.976). Method comparison with an existing fully mechanized method as well as with ELISA tests for sTfR showed very good correlation (r>0.987). Because of the lack of international standardization the results differed from each other up to 2.5-fold. The 95% of serum levels in healthy individuals ranged from 1.9 to 4.4 mg/l (n=427). However, the reference ranges should be reported in a sex-dependent manner, as 2.2–5.0 mg/l for men (n=211) and as 1.9–4.4 mg/l for premenopausal (n=216) and postmenopausal (n=45) women. The Tina quant®[a] sTfR assay enables the precise, accurate, rapid and convenient determination of sTfR concentrations for routine clinical chemistry purposes.

Clinical Chemical Laboratory Medicine, Walter de Gruyter

Print ISSN: 1434-6621
Volume: 40, 06/2002
Pages: 529 - 536

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