CLSI C53 P : 1ED 2008

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
   4.1 A Note on Terminology
   4.2 Definitions
   4.3 Abbreviations/Acronyms
5 Qualification Requirements
   5.1 Definition of the Measurand
   5.2 Intended Use
   5.3 Material Specifications
6 Characterization of Homogeneity, Stability, and Property Value
   6.1 Characterization of Homogeneity
   6.2 Characterization of Stability
   6.3 Establishing Traceability
7 Characterization of Commutability of Reference Materials
   7.1 General Considerations Regarding Samples and Measurement
        Procedures Used for Commutability Validation
   7.2 Logistical Considerations of a Commutability Validation
   7.3 Procedures for Commutability Validation and Assessing
        Numeric Relationships
   7.4 Selection of a Procedure to Validate Commutability
   7.5 Criteria for Acceptance of the Equivalence of the
        Mathematical Relationship for Native Clinical Samples
        and Candidate Reference Materials
   7.6 Reporting Commutability Information
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 Mathematical Model Used for
             Evaluating Commutability of Reference Materials
             Using Deming Regression
Appendix D - Procedure for Establishing Commutability of a
             Reference Material With Native Clinical Specimens
             for a Pair of Measurement Methods With Deming
             Regression
The Quality Management System Approach
Related CLSI Reference Materials

Describes information to help material manufacturers in the production and characterization of commutable reference materials as well as assist assay manufacturers, proficiency testing providers, and laboratorians in the appropriate use of these materials for calibration and trueness assessment of in vitro diagnostic medical devices.