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When is a serum iron really a serum iron? The status of serum iron measurements

N W Tietz1, A D Rinker, S R Morrison

  • 1Department of Pathology and Laboratory Medicine, University of Kentucky Medical Center, Lexington 40536-0084.

Clinical Chemistry
|April 1, 1994
PubMed

Insights

Routine serum iron tests show significant inaccuracies, questioning their reliability for diagnosing iron deficiency. Current methods exhibit biases and poor correlation, especially at low concentrations.

Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Diagnostic Accuracy

Background:

  • Serum iron determinations are crucial for diagnosing conditions like iron deficiency anemia.
  • Existing routine methods for serum iron measurement have raised concerns regarding their accuracy and reliability.
  • Performance issues with current assays are frequently highlighted in external quality assessment programs.

Purpose of the Study:

  • To evaluate the accuracy and reliability of commonly used routine methods for serum iron determination.
  • To compare the performance of various automated analyzers against established reference methods.
  • To assess the suitability of routine methods for accurately quantifying low serum iron concentrations relevant to iron deficiency diagnosis.

Main Methods:

  • Comparison of routine serum iron assays (DuPont aca, Abbott TDx, Kodak Ektachem, BM/Hitachi 717, Synermed) against the 1990 International Committee for Standardization in Haematology (ICSH) reference method.
  • Analysis of bias, intercept, and correlation coefficients for iron values across the analytical range.
  • Evaluation of method performance based on data from College of American Pathologists surveys.

Main Results:

  • Routine methods demonstrate significant negative bias and poor correlation with the 1990 ICSH method, particularly for serum iron levels below 750 micrograms/L.
  • The 1978 ICSH Reference Method and the National Committee for Clinical Laboratory Standards method also show notable biases (+3.4% and -17.8%, respectively) compared to the 1990 ICSH method.
  • Observed discrepancies between methods reached several hundred percent, indicating substantial analytical variability.
  • Imprecision was ruled out as the primary cause of these observed discrepancies.

Conclusions:

  • Current routine serum iron assays exhibit substantial inaccuracies and biases, compromising their diagnostic utility.
  • The reliability of low serum iron concentration measurements by routine methods is questionable for confirming iron deficiency.
  • Further improvements in analytical methods are necessary to ensure accurate and dependable serum iron testing for clinical diagnosis.

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