Multicenter evaluation of a fully mechanized soluble transferrin receptor assay on the Hitachi and cobas integra analyzers. the determination of reference ranges

Clin Chem Lab Med. 2002 May;40(5):529-36. doi: 10.1515/CCLM.2002.091.

Abstract

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.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anemia, Iron-Deficiency / diagnosis
  • Female
  • Hematologic Tests
  • Humans
  • Latex Fixation Tests / methods
  • Latex Fixation Tests / standards
  • Male
  • Middle Aged
  • Nephelometry and Turbidimetry / methods*
  • Nephelometry and Turbidimetry / standards
  • Receptors, Transferrin / blood*
  • Reference Values
  • Reproducibility of Results
  • Sex Factors
  • Solubility

Substances

  • Receptors, Transferrin