CLSI EP30 A : 1ED 2010

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Qualification Requirements
6 Characterization of Homogeneity, Stability, and Property
  Value
7 Characterization of Commutability of Reference Materials
8 Considerations for Reference Materials Intended for
  Immediate Use and/or Limited Available Quantities
References
Appendix A - Examples of Value Transfer Procedures
Appendix B - Hypothetical Data Set Used for Examples of
             Procedures for Assessment of Commutability
Appendix C - Description of a Mathematical Model Used for
             Evaluating Commutability of Reference Materials
             Using Deming Regression
Appendix D - Procedure for Establishing Commutability of
             Reference Materials With Native Clinical
             Specimens for a Pair of Measurement Methods
             Using Deming Regression
Appendix E - Cross-Tables to Describe Commutability Results
Summary of Delegate Comments and Subcommittee Responses
The Quality Management System Approach
Related CLSI Reference Materials

This guideline provides recommendations for the characterization, assessment of commutability, and assignment of analyte concentration or activity values to reference materials (RMs) that are used for calibration and trueness assessment of in vitro diagnostic medical devices.