CLSI EP30 A : 1ED 2010
Current
The latest, up-to-date edition.
CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
Hardcopy , PDF
English
28-05-2010
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
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.