CLSI EP28 A3 : 3ED 2010

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Use of Système International d'Unités (SI Units)
6 Protocol Outline for Obtaining Reference Values and
   Establishing Reference Intervals
7 Selection of Reference Individuals
8 Preanalytical and Analytical Considerations
9 Analysis of Reference Values
10 Transference
11 Validation
12 Presentation of Reference Values
13 Other Issues
14 Summary
References
Appendix A - Effectiveness of Several Statistical Tests in
             Validating Transference of Reference Intervals
Appendix B - Robust Calculation
Summary of Consensus Comments and Subcommittee Responses
Summary of Delegate Comments and Subcommittee Responses
The Quality Management System Approach
Related CLSI Reference Materials

Provides guidelines for determining reference values and reference intervals for quantitative clinical laboratory tests.

This document provides diagnostic laboratories and diagnostic test manufacturers with updated guidelines for determining reference intervals for quantitative laboratory tests. It includes specific recommendations regarding procedures that can be used to establish and verify reliable reference intervals for use in clinical laboratory medicine. By following these recommendations, laboratories can provide reference intervals that are adequate and useful for clinical interpretation.Issues related to the reference subject selection process, the importance of preanalytical and analytical considerations, the calculation methods and requirements for estimating valid reference intervals, and the transference of reference intervals are discussed. Examples of the recommended estimation and calculation processes are provided. Finally, issues related to the presentation and use of reference intervals are discussed, followed by a brief section that examines a number of important but collateral reference value topics not amenable to inclusion in this document.