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CLSI EP30 A : 1ED 2010

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE

Available format(s)

Hardcopy , PDF

Superseded date

02-08-2024

Language(s)

English

Published date

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

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.

DevelopmentNote
Supersedes NCCLS C53 P. (06/2010) Formerly CLSI C53 A. (07/2013)
DocumentType
Standard
ISBN
1-56238-726-X
Pages
76
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy
Supersedes

CLSI EP19 : 2ED 2015 A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES
CSA ISO 15197 : 2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
CLSI EP26 A : 1ED 2013 USER EVALUATION OF BETWEEN-REAGENT LOT VARIATION
CLSI POCT12 A3 : 3ED 2013 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition<br>
CLSI EP21 : 2ED 2016 EVALUATION OF TOTAL ANALYTICAL ERROR FOR QUANTITATIVE MEDICAL LABORATORY MEASUREMENT PROCEDURES
CLSI EP14 A3 : 2014 EVALUATION OF COMMUTABILITY OF PROCESSED SAMPLES
ISO Guide 80:2014 Guidance for the in-house preparation of quality control materials (QCMs)
I.S. EN ISO 15197:2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
ISO Guide 30:2015 Reference materials — Selected terms and definitions
ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
CLSI C57 : 1ED 2015 MASS SPECTROMETRY FOR ANDROGEN AND ESTROGEN MEASUREMENTS IN SERUM
12/30271500 DC : 0 BS ISO GUIDE 80 - GUIDANCE FOR IN-HOUSE PRODUCTION OF REFERENCE MATERIALS FOR QUALITY CONTROL (QCMS)
13/30294275 DC : 0 BS ISO GUIDE 30 - REFERENCE MATERIALS - SELECTED TERMS AND DEFINITIONS
PD ISO GUIDE 30:2015 Reference materials. Selected terms and definitions
CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES

CLSI EP14 A2 : 2ED 2005 EVALUATION OF MATRIX EFFECTS
CLSI C37 A : 1ED 99 PREPARATION AND VALIDATION OF COMMUTABLE FROZEN HUMAN SERUM POOLS AS SECONDARY REFERENCE MATERIALS FOR CHOLESTEROL MEASUREMENT PROCEDURES
CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
CLSI EP6 A : 1ED 2003 EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI EP32 R : 1ED 2006 METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION
CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY

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