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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 / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2017: 3.556

CiteScore 2017: 2.34

SCImago Journal Rank (SJR) 2017: 1.114
Source Normalized Impact per Paper (SNIP) 2017: 1.188

Online
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1437-4331
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Volume 48, Issue 6

Issues

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

Susan J. Thorpe / Alan Heath / Giles Sharp / James Cook / Richard Ellis / Mark Worwood
Published Online: 2010-05-06 | DOI: https://doi.org/10.1515/CCLM.2010.167

Abstract

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

About the article

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


Received: 2010-01-11

Accepted: 2010-02-26

Published Online: 2010-05-06

Published in Print: 2010-06-01


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

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