Standard Document
First Edition
Clinical Chemistry and Toxicology

CLSI C61

Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation

CLSI C61 provides guidance on measuring serum iron concentration, total iron-binding capacity (TIBC), and transferrin saturation. This guideline outlines standardized methods for these determinations, ensuring accuracy, minimal interference, and adequate precision. While these measurements have traditionally been labor-intensive, the document also addresses semi-automated approaches to improve efficiency and reduce sample size. Additionally, it includes reference ranges by age, race, and gender, derived from U.S. National Health and Nutrition Examination Surveys, to support clinically relevant interpretation of iron status.

December 01, 1998
Onno van Assendelft, MD, PhD

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Abstract

This document describes the measurement of serum iron concentration, provides guidelines for the determination of serum total iron-binding capacity, and describes the determination of the percent saturation of transferrin with iron. The methods are linear over a wide range of iron concentrations, interference is negligible, and the precision is adequate. Although the methods, as described, are tedious and demand a large sample size and meticulous processing, they can be (semi)automated and the required amount of sample can be decreased. An example of automation is included. The document also provides reference ranges by age groups, race, and gender for serum iron concentration, total iron-binding capacity, and % transferrin saturation as determined during the U.S. National Health and Nutrition Examination Surveys, 1971-74, 1976-80, and 1988-94.

Scope

This standard describes the recommended method for the determination of serum iron, guidelines for the determination of TIBC, and the calculation of % transferrin iron saturation. Accurate determinations are required: 

• for the evaluation of patient iron status and the differential diagnosis of anemia; 

• for screening and diagnosis of iron overload syndromes; and 

• in the evaluation of other manual or automated methods for the determination of these analytes. 

This standard is thus intended primarily for clinical laboratory personnel.

Product Details
C61AE
1-56238-362-0
60
Authors
Onno W. van Assendelft, M.D., Ph.D., Chairholder
Basil T. Doumas, Ph.D.
Virgil F. Fairbanks, M.D.
Elaine W. Gunter, M.T.(ASCP)
Daniel A. Nealon, Ph.D.
Abstract

This document describes the measurement of serum iron concentration, provides guidelines for the determination of serum total iron-binding capacity, and describes the determination of the percent saturation of transferrin with iron. The methods are linear over a wide range of iron concentrations, interference is negligible, and the precision is adequate. Although the methods, as described, are tedious and demand a large sample size and meticulous processing, they can be (semi)automated and the required amount of sample can be decreased. An example of automation is included. The document also provides reference ranges by age groups, race, and gender for serum iron concentration, total iron-binding capacity, and % transferrin saturation as determined during the U.S. National Health and Nutrition Examination Surveys, 1971-74, 1976-80, and 1988-94.

Scope

This standard describes the recommended method for the determination of serum iron, guidelines for the determination of TIBC, and the calculation of % transferrin iron saturation. Accurate determinations are required: 

• for the evaluation of patient iron status and the differential diagnosis of anemia; 

• for screening and diagnosis of iron overload syndromes; and 

• in the evaluation of other manual or automated methods for the determination of these analytes. 

This standard is thus intended primarily for clinical laboratory personnel.

Authors
Onno W. van Assendelft, M.D., Ph.D., Chairholder
Basil T. Doumas, Ph.D.
Virgil F. Fairbanks, M.D.
Elaine W. Gunter, M.T.(ASCP)
Daniel A. Nealon, Ph.D.