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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Tate, Jillian R. / Tsongalis, Gregory J.

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A WHO Reference Reagent for the Serum Transferrin Receptor (sTfR): international collaborative study to evaluate a recombinant soluble transferrin receptor preparation

Susan J. Thorpe1 / Alan Heath1 / Giles Sharp1 / James Cook2 / Richard Ellis3 / Mark Worwood4

1National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK

2University of Kansas, Medical Center, Kansas City, KS, USA

3University Hospital of Wales, Cardiff, UK

4School of Medicine, Cardiff University, Cardiff, UK

Corresponding author: Susan J. Thorpe, Biotherapeutics Group, NIBSC, Blanche Lane, South Mimms, Potters Bar, Herts EN6 3QG, UK Fax: +44 (0)1707 641057,

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 48, Issue 6, Pages 815–820, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2010.167, May 2010

Publication History

Published Online:


Background: The usefulness of serum transferrin receptor (sTfR) as a marker of iron deficiency is limited by lack of standardization of commercial immunoassays for sTfR. An international collaborative study was performed to evaluate a lyophilized preparation of recombinant soluble transferrin receptor (rsTfR) for its suitability to serve as a World Health Organization (WHO) Reference Reagent to standardize immunoassays for sTfR.

Methods: The concentration of pure rsTfR was determined from the A280 nm using the adjusted theoretical extinction coefficient and molecular weight calculated from its sequence, before dilution and lyophilization in a sTfR-depleted serum matrix. Six manufacturers and a health protection laboratory assayed the candidate Reference Reagent, coded 07/202, along with three lyophilized serum samples, using commercial assays for sTfR.

Results: Dose-response plots demonstrated acceptable overall parallelism between 07/202, manufacturers' in-house standards, and serum samples. However, there was poor agreement on the estimated (r)sTfR content of 07/202 and serum samples. Expressing the sTfR content of the serum samples relative to 07/202 markedly improved agreement between methods.

Conclusions: Use of 07/202 would reduce inter-method variability. The preparation was established as the 1st WHO Reference Reagent for sTfR with assigned free rsTfR monomer values of 21.7 mg/L and 303 nmol/L (0.5 mL reconstitution).

Clin Chem Lab Med 2010;48:815–20.

Keywords: iron deficiency marker; sTfR immunoassays; standardization

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