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C61-A: Determination of Serum Iron, Total Iron-Binding Capacity

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C61-A: Determination of Serum Iron, Total Iron-Binding Capacity December 1998 C61-A Determination of Serum Iron, Total Iron- Binding Capacity and Percent Transferrin Saturation; Approved Standard This document provides methods for determining serum iron and total iron-binding capacity; and describes the measurement ofSAMPLE serum iron concentration as well as the determination of the percent saturation of transferrin with iron. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. SettingClinical the standard and for quality Laboratoryin clinical laboratory testing aroundStandards the world. Institute The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. Consensus Process Consensus—the substantial agreement by materially affected, competent, and interested parties—is core to the development of all CLSI documents. It does not always connote unanimous agreement, but does mean that the participants in the development of a consensus document have considered and resolved all relevant objections and accept the resulting agreement. Commenting on Documents CLSI documents undergo periodic evaluation and modification to keep pace with advancements in technologies, procedures, methods, and protocols affecting the laboratory or health care. CLSI’s consensus process depends on experts who volunteer to serve as contributing authors and/or as participants in the reviewing and commenting process. At the end of each comment period, the committee that developed the document is obligated to review all comments, respond in writing to all substantive comments, and revise the draft document as appropriate. Comments on published CLSI documents are equally essential, and may be submitted by anyone, at any time, on any document. All comments are addressed according to the consensus process by a committee of experts. Appeals Process If it is believed that an objection has not been adequately addressed, the process for appeals is documented in the CLSI Administrative Procedures. All comments and responses submitted on draft and published documents are retained on file at CLSI and are available upon request. Get Involved—Volunteer! Do you use CLSI documents in your workplace? Do you see room for improvement? Would you like to get involved in the revision process? Or maybe you see a need to develop a new document for an emerging technology? CLSI wants to hear from you. We are always looking for volunteers. By donating your time and talents to improve the standards that affect your own work, you will play an active role in improving public health across the globe. SAMPLE For further information on committee participation or to submit comments, contact CLSI. Clinical and Laboratory Standards Institute 950 West Valley Road, Suite 2500 Wayne, PA 19087 USA P: 610.688.0100 F: 610.688.0700 www.clsi.org [email protected] Vol. 18 No. 19 H17-A NOTE: In an effort to more accurately categorize our library of documents, some CLSI documents were recently assigned new codes. H17‐A is now C61‐A. Visit www.clsi.org for the complete list of affected documents. Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard 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. Clinical and Laboratory Standards Institute (CLSI). Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard. CLSI document C61-A (ISBN 1-56238-362-0). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 1998. The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through two or more levels of review by the health care community, is an ongoing process. Users should expect revised editions of any given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI documents. Current editions are listed in the CLSI catalog and posted on our website at www.clsi.org. If your organization is not a member and would like to become one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail: [email protected]; Website: www.clsi.org. SAMPLE i NOTE: This document is no longer being reviewed as part of the CLSI consensus process. However, because of its usefulness to segments of the health care community, it is available for its informational content. C61-A ISBN 1-56238-362-0 December 1998 ISSN 0273-3099 Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard Volume 18 Number 19 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. SAMPLE December 1998 NCCLS Copyright ©1998 Clinical and Laboratory Standards Institute. Except as stated below, any reproduction of content from a CLSI copyrighted standard, guideline, companion product, or other material requires express written consent from CLSI. All rights reserved. Interested parties may send permission requests to [email protected]. CLSI hereby grants permission to each individual member or purchaser to make a single reproduction of this publication for use in its laboratory procedure manual at a single site. To request permission to use this publication in any other manner, e-mail [email protected]. Suggested Citation CLSI. Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard. CLSI document C61-A. Wayne, PA: Clinical and Laboratory Standards Institute; 1998. Proposed Standard February 1990 Approved Standard December 1998 ISBN 1-56238-362-0SAMPLE ISSN 0273-3099 iv Vol. 18 No. 19 H17-A Contents Abstract .............................................................. i Committee Membership ................................................... v Active Membership ......................................................vii Foreword .............................................................xv 1 Introduction ...................................................... 1 2 Scope .......................................................... 1 3 Units of Measurement ............................................... 1 4 Specimens ....................................................... 2 5 Standard Precautions ................................................ 2 6 Recommended Method for the Determination of Serum Iron ..................... 2 6.1 Principle of the Method .......................................... 2 6.2 Materials .................................................... 2 6.3 Reagents .................................................... 3 6.4 Iron Standard Solutions .......................................... 4 6.5 Determination of Serum Iron Concentration ............................. 4 6.6 Quality Control ................................................ 5 6.7 Interferences and Sources of Error ................................... 7 6.8 Alternative Chromogen .......................................... 7 6.9 Reference Range ............................................... 7 7 Guideline for the Determination of Total Iron Binding Capacity of Serum, TIBC ......... 8 7.1 Principle of the Method .......................................... 8 7.2 Materials .................................................... 9 7.3 Reagents .................................................... 9 7.4 Determination of Total Iron Binding Capacity of Serum, TIBC ................ 10 7.5 Quality Control ............................................... 11 7.6 Interferences and Sources of Error .................................. 11 7.7 Reference Range .............................................. 12 8 Calculation of Percent Transferrin Saturation ............................... 13 8.1 Transferrin .................................................. 13 8.2 Transferrin Measurement ........................................ 13 8.3 % TransferrinSAMPLE Saturation ........................................ 14 8.4 Reference Range .............................................. 14 8.5 Interpretation of Results ......................................... 14 References .........................................................
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