Document Detail


A WHO reference reagent for the Serum Transferrin Receptor (sTfR): international collaborative study to evaluate a recombinant soluble transferrin receptor preparation.
MedLine Citation:
PMID:  20446759     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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 A(280 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).
Authors:
Susan J Thorpe; Alan Heath; Giles Sharp; James Cook; Richard Ellis; Mark Worwood
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Clinical chemistry and laboratory medicine : CCLM / FESCC     Volume:  48     ISSN:  1434-6621     ISO Abbreviation:  Clin. Chem. Lab. Med.     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-06-03     Completed Date:  2010-09-09     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9806306     Medline TA:  Clin Chem Lab Med     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  815-20     Citation Subset:  IM    
Affiliation:
National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK. susan.thorpe@nibsc.hpa.org.uk
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MeSH Terms
Descriptor/Qualifier:
Immunoassay / methods,  standards*
Indicators and Reagents
Protein Stability
Receptors, Transferrin / blood*,  genetics
Recombinant Proteins / blood,  genetics,  standards*
Reference Standards
Reproducibility of Results
World Health Organization
Chemical
Reg. No./Substance:
0/Indicators and Reagents; 0/Receptors, Transferrin; 0/Recombinant Proteins
Comments/Corrections
Comment In:
Clin Chem Lab Med. 2010 Jun;48(6):747-8   [PMID:  20441465 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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