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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. Thorpe , Alan Heath , Giles Sharp , James Cook , Richard Ellis and Mark Worwood
Published/Copyright: May 6, 2010
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Clinical Chemistry and Laboratory Medicine
From the journal Clinical Chemistry and Laboratory Medicine Volume 48 Issue 6

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
Corresponding author: Susan J. Thorpe, Biotherapeutics Group, NIBSC, Blanche Lane, South Mimms, Potters Bar, Herts EN6 3QG, UK Fax: +44 (0)1707 641057,
Received: 2010-1-11
Accepted: 2010-2-26
Published Online: 2010-05-6
Published in Print: 2010-06-01

©2010 by Walter de Gruyter Berlin New York

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https://doi.org/10.1515/CCLM.2010.167
Keywords for this article
iron deficiency marker; sTfR immunoassays; standardization

Articles in the same Issue

  1. Editorials
  2. The “Obamanomics”: a revolution in laboratory diagnostics
  3. Skeletal muscle biomarkers: not new but still interesting diagnostic tools
  4. Necessity for high-quality reference materials in the harmonization of laboratory assays
  5. Reviews
  6. Rhabdomyolysis: historical background, clinical, diagnostic and therapeutic features
  7. Biochemical markers of muscular damage
  8. Minireview
  9. Interpretation of serum parathyroid hormone concentrations in dialysis patients: what do the KDIGO guidelines change for the clinical laboratory?
  10. Guidelines and Recommendations
  11. 2010 Consensus statement on the worldwide standardization of the hemoglobin A1c measurement
  12. Genetics and Molecular Diagnostics
  13. Development of a low-cost real-time reverse transcriptase-polymerase chain reaction technique for the detection and quantification of hepatitis C viral load
  14. Microsatellite polymorphisms in intron 2 of the toll-like receptor 2 gene and their association with susceptibility to pulmonary tuberculosis in Han Chinese
  15. Evaluation of a panel of circulating DNA, RNA and protein potential markers for pathologies of pregnancy
  16. General Clinical Chemistry and Laboratory Medicine
  17. Traceability of values for catalytic activity concentration of enzymes: a Certified Reference Material for aspartate transaminase
  18. Development and preparation of a new serum protein reference material: feasibility studies and processing
  19. A WHO Reference Reagent for the Serum Transferrin Receptor (sTfR): international collaborative study to evaluate a recombinant soluble transferrin receptor preparation
  20. Hyperhomocysteinemia is not associated with reduced bone quality in humans with hip osteoarthritis
  21. Diagnostic performance of anti-citrullinated peptide antibodies for the diagnosis of rheumatoid arthritis: the relevance of likelihood ratios
  22. New quantitative electrochemiluminescence method (ECLIA) for interleukin-6 (IL-6) measurement
  23. Evaluation of cell counting and leukocyte differentiation in cerebrospinal fluid controls using hematology analyzers by the German Society for Clinical Chemistry and Laboratory Medicine
  24. Reference Values and Biological Variations
  25. The relationship of coffee and green tea consumption with high-sensitivity C-reactive protein in Japanese men and women
  26. Cancer Diagnostics
  27. Potential biomarkers for esophageal carcinoma detected by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry
  28. Identification of candidate molecular markers predicting chemotherapy resistance in non-small cell lung cancer
  29. Factors affecting soluble mesothelin related protein levels in an asbestos-exposed population
  30. Cardiovascular Diseases
  31. Dynamic changes in N-terminal pro-brain natriuretic peptide in acute coronary syndromes treated with percutaneous coronary intervention: a marker of ischemic burden, reperfusion and outcome
  32. Performance characteristics of a microfluidic Lab-on-Chip electrophoresis system for high-density lipoprotein (HDL) subfraction separation and measurement
  33. Letters to the Editor
  34. Hemolysis correction factor in the measurement of serum neuron-specific enolase
  35. Serum paraoxonase-1 activity and genetic polymorphisms: common errors in measurement and interpretation of results
  36. Neuropharmacology of schizophrenia: is there a role for leptin?
  37. Relationship between serum concentrations of keratin-18 and apoptosis in chronic hepatitis C
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